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    HP:0000083: Renal insufficiency

    Developed by Shray Alag, The Harker School
    Sections: Correlations, Clinical Trials, and HPO

    Correlations computed by analyzing all clinical trials.

    Navigate: Clinical Trials and HPO


    Correlated Drug Terms (9)


    Name (Synonyms) Correlation
    drug3032 PF-06882961 20 mg Wiki 0.33
    drug2486 MT-7117 Wiki 0.33
    drug747 CE-Iohexol Wiki 0.33
    Name (Synonyms) Correlation
    drug1412 EHR-based Clinician Jumpstart Wiki 0.33
    drug524 BMS-986259 Wiki 0.33
    drug2214 Iohexol Wiki 0.33
    drug189 AZD9977 Wiki 0.24
    drug2655 Mobocertinib Wiki 0.24
    drug1238 DWRX2003 Wiki 0.19

    Correlated MeSH Terms (18)


    Name (Synonyms) Correlation
    D051437 Renal Insufficiency, NIH 1.00
    D016491 Peripheral Vascular Diseases NIH 0.19
    D008103 Liver Cirrhosis, NIH 0.17
    Name (Synonyms) Correlation
    D058729 Peripheral Arterial Disease NIH 0.17
    D014652 Vascular Diseases NIH 0.17
    D007676 Kidney Failure, Chronic NIH 0.14
    D009362 Neoplasm Metastasis NIH 0.13
    D051436 Renal Insufficiency, Chronic NIH 0.11
    D017563 Lung Diseases, Interstitial NIH 0.09
    D002908 Chronic Disease NIH 0.09
    D008175 Lung Neoplasms NIH 0.08
    D006333 Heart Failure NIH 0.08
    D007674 Kidney Diseases NIH 0.08
    D029424 Pulmonary Disease, Chronic Obstructive NIH 0.08
    D003924 Diabetes Mellitus, Type 2 NIH 0.07
    D008171 Lung Diseases, NIH 0.06
    D003920 Diabetes Mellitus, NIH 0.05
    D009369 Neoplasms, NIH 0.05

    Correlated HPO Terms (12)


    Name (Synonyms) Correlation
    HP:0001395 Hepatic fibrosis HPO 0.17
    HP:0004950 Peripheral arterial stenosis HPO 0.13
    HP:0012622 Chronic kidney disease HPO 0.11
    Name (Synonyms) Correlation
    HP:0006515 Interstitial pneumonitis HPO 0.09
    HP:0100526 Neoplasm of the lung HPO 0.08
    HP:0001635 Congestive heart failure HPO 0.08
    HP:0000077 Abnormality of the kidney HPO 0.08
    HP:0006510 Chronic pulmonary obstruction HPO 0.08
    HP:0005978 Type II diabetes mellitus HPO 0.07
    HP:0002088 Abnormal lung morphology HPO 0.06
    HP:0000819 Diabetes mellitus HPO 0.05
    HP:0002664 Neoplasm HPO 0.05

    Clinical Trials

    Navigate: Correlations   HPO

    There are 9 clinical trials


    1 A Phase 1 Pharmacokinetic Study of Oral Mobocertinib in Subjects With Severe Renal Impairment and Normal Renal Function

    The purpose of this study is to characterize the single-dose plasma and urine PK of mobocertinib and its active metabolites (AP32960 and AP32914) in participants with severe RI compared to matched-healthy participants with normal renal function.

    NCT04056455
    Conditions
    1. Renal Impairment
    2. Healthy Volunteers
    Interventions
    1. Drug: Mobocertinib
    MeSH:Renal Insufficiency
    HPO:Renal insufficiency

    Primary Outcomes

    Measure: Cmax: Maximum Observed Plasma Concentration for Mobocertinib and its Active Metabolites (AP32960 and AP32914)

    Time: Day 1 pre-dose and at multiple time points (up to 216 hours) post-dose

    Measure: Cmax,u: Maximum Observed Unbound Plasma Concentration for Mobocertinib and its Active Metabolites (AP32960 and AP32914)

    Time: Day 1 pre-dose and at multiple time points (up to 216 hours) post-dose

    Measure: AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Mobocertinib and its Active Metabolites (AP32960 and AP32914)

    Time: Day 1 pre-dose and at multiple time points (up to 216 hours) post-dose

    Measure: AUCinf,u: Area Under the Unbound Plasma Concentration-time Curve From Time 0 to Infinity for Mobocertinib and its Active Metabolites (AP32960 and AP32914)

    Time: Day 1 pre-dose and at multiple time points (up to 216 hours) post-dose

    Measure: AUClast: Area Under the Plasma Concentration-time Curve from Time 0 to the Time of the Last Quantifiable Concentration for Mobocertinib and its Active Metabolites (AP32960 and AP32914)

    Time: Day 1 pre-dose and at multiple time points (up to 216 hours) post-dose

    Measure: AUClast,u: Area Under the Unbound Plasma Concentration-time Curve from Time 0 to the Time of the Last Quantifiable Concentration for Mobocertinib and its Active Metabolites (AP32960 and AP32914)

    Time: Day 1 pre-dose and at multiple time points (up to 216 hours) post-dose

    Measure: Combined Molar Unbound Cmax, for Mobocertinib and its Active Metabolites (AP32960 and AP32914)

    Time: Day 1 pre-dose and at multiple time points (up to 216 hours) post-dose

    Measure: Combined Molar Unbound AUClast, for Mobocertinib and its Active Metabolites (AP32960 and AP32914)

    Time: Day 1 pre-dose and at multiple time points (up to 216 hours) post-dose

    Measure: Combined Molar Unbound AUCinf, for Mobocertinib and its Active Metabolites (AP32960 and AP32914)

    Time: Day 1 pre-dose and at multiple time points (up to 216 hours) post-dose

    Measure: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Mobocertinib and its Active Metabolites (AP32960 and AP32914)

    Time: : Day 1 pre-dose and at multiple time points (up to 216 hours) post-dose

    Measure: t1/2z: Terminal Disposition Phase Half-life for Mobocertinib and its Active Metabolites (AP32960 and AP32914)

    Time: Day 1 pre-dose and at multiple time points (up to 216 hours) post-dose

    Measure: λz: Terminal Disposition Phase Rate Constant for Mobocertinib and its Active Metabolites (AP32960 and AP32914)

    Time: Day 1 pre-dose and at multiple time points (up to 216 hours) post-dose

    Measure: CL/F: Apparent Clearance After Extravascular Administration for Mobocertinib

    Time: Day 1 pre-dose and at multiple time points (up to 216 hours) post-dose

    Measure: CLu/F: Apparent Clearance for Unbound Drug After Extravascular Administration for Mobocertinib

    Time: Day 1 pre-dose and at multiple time points (up to 216 hours) post-dose

    Measure: Vz/F: Apparent Volume of Distribution During the Terminal Disposition Phase After Extravascular Administration for Mobocertinib

    Time: Day 1 pre-dose and at multiple time points (up to 216 hours) post-dose

    Measure: Vz,u/F: Apparent Volume of Distribution for Unbound Drug During the Terminal Disposition Phase After Extravascular Administration for Mobocertinib

    Time: Day 1 pre-dose and at multiple time points (up to 216 hours) post-dose

    Measure: Aet: Amount of Drug Excreted in Urine From Time 0 to time t for Mobocertinib and its Active Metabolites (AP32960 and AP32914)

    Time: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose

    Measure: fe,t: Fraction of Administered Dose Excreted in Urine From Time 0 to Time t for Mobocertinib and its Active Metabolites (AP32960 and AP32914)

    Time: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose

    Measure: CLR: Renal Clearance for Mobocertinib and its Active Metabolites (AP32960 and AP32914)

    Time: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose

    Secondary Outcomes

    Measure: Plasma Protein Binding of Mobocertinib and its Active Metabolites (AP32960 and AP32914)

    Time: Day 1 at multiple time points (up to 24 hours) post-dose

    Measure: Number of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs)

    Time: Baseline up to 30 days after the last of study drug (Day 31)
    2 A Phase 1, Open-Label, Multiple-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BMS-986259 in Participants With Varying Degrees of Renal Function

    A study to evaluate the drug effect, safety, and tolerability of BMS-986259 in participants with different levels of kidney function

    NCT04237831
    Conditions
    1. Renal Failure
    Interventions
    1. Drug: BMS-986259
    MeSH:Renal Insufficiency
    HPO:Renal insufficiency

    Primary Outcomes

    Measure: Maximum plasma Concentration (Cmax) of BMS-986259 in Blood serum

    Time: Day 1 and Day 8

    Measure: Time to reach maximum concentration in plasma (Tmax) of BMS-986259 in blood serum

    Time: Day 1 and Day 8

    Measure: Area under the concentration- time curve over the dosing interval of BMS-986259 in blood serum - AUC(TAU)

    Time: Day 1 and Day 8

    Measure: Concentration of BMS-986259 in blood serum at 24 hours (C24)

    Time: Day 1 and Day 8

    Measure: Area under the concentration-time curve of BMS-986259 from time 0 (dosing) to the time of the last quantifiable - AUC(0-T)

    Time: Day 8

    Measure: Accumulation ratio in the maximum plasma concentration of BMS-986259 in blood serum -AR(Cmax)

    Time: Day 8

    Measure: Accumulation ratio of Area under the concentration-time curve in BMS-986259 over the dosing interval -AR (AUC [TAU])

    Time: Day 8

    Measure: Accumulation ratio concentration of BMS-986259 at 24 hours- AR(C24)

    Time: Day 8

    Measure: Terminal elimination half-life of BMS-986259 (T-HALF)

    Time: Day 8

    Measure: Apparent total clearance of BMS-986259 at steady-state (CLss/F)

    Time: Day 8

    Measure: Apparent volume of distribution of BMS-986259 at terminal phase at steady-state (Vss/F)

    Time: Day 8

    Secondary Outcomes

    Measure: Incidence of Non serious Adverse Events (AEs)

    Time: Up to 4 months

    Measure: Incidence of Serious Adverse Events (SAEs)

    Time: Up to 4 months

    Measure: Incidence of AEs leading to discontinuation

    Time: Up to 4 months

    Measure: Number of clinically significant changes in vital signs

    Time: Up to 4 months

    Measure: Number in clinically significant changes in Electrocardiogram (ECG)

    Time: Up to 4 months

    Measure: Number of clinically significant changes in physical examinations

    Time: Up to 4 months

    Measure: Number of clinically significant changes in clinical laboratory tests

    Time: Up to 4 months
    3 Using the Electronic Health Record to Identify and Promote Goals-of-Care Communication for Older Patients With Serious Illness

    The objective of this protocol is to test the effectiveness of a Jumpstart intervention on patient-centered outcomes for patients with chronic illness by ensuring that they receive care that is concordant with their goals over time, and across settings and providers. This study will examine the effect of the EHR-based intervention to improve quality of palliative care for patients over the age of 65 with chronic, life-limiting illness with a particular emphasis on Alzheimer's disease and related dementias (ADRD). The specific aims are: 1) to evaluate the effectiveness of a novel EHR-based (electronic health record) clinician Jumpstart guide, compared with usual care, for improving the quality of care; the primary outcome is documentation of a goals-of-care discussion during the hospitalization. Secondary outcomes focus on intensity of care: ICU use, ICU and hospital length of stay, costs of care during the hospitalization, and 30-day hospital readmissions; and 2) to conduct a mixed-methods evaluation of the implementation of the Jumpstart intervention, guided by the RE-AIM and CFIR frameworks for implementation science, incorporating quantitative assessments of effectiveness, implementation and maintenance and qualitative assessments of clinician perspectives on barriers and facilitators to future implementation and dissemination.

    NCT04281784
    Conditions
    1. Dementia
    2. Chronic Disease
    3. Neoplasm Metastasis
    4. Lung Neoplasm
    5. Pulmonary Disease, Chronic Obstructive
    6. Heart Failure,Congestive
    7. Liver Cirrhosis
    8. Kidney Failure, Chronic
    9. Lung Diseases, Interstitial
    10. Peripheral Vascular Disease
    11. Diabetes With End Organ Injury
    12. Palliative Care, Patient Care
    13. Health Care Quality, Access, and Evaluation
    14. Patient Care
    15. Inpatients
    16. Health Communication
    17. Patient Care Planning
    Interventions
    1. Behavioral: EHR-based Clinician Jumpstart
    MeSH:Neoplasms Neoplasm Metastasis Lung Neoplasms Liver Cirrhosis Lung Diseases Pulmonary Disease, Chronic Obstructive Lung Diseases, Interstitial Renal Insufficiency Kidney Failure, Chronic Heart Failure Vascular Diseases Peripheral Vascular Diseases Peripheral Arterial Disease Chronic Disease
    HPO:Abnormal left ventricular function Abnormal lung morphology Abnormal pulmonary Interstitial morphology Chronic pulmonary obstruction Cirrhosis Congestive heart failure Hepatic fibrosis Interstitial pneumonitis Neoplasm Neoplasm of the lung Peripheral arterial stenosis Renal insufficiency Right ventricular failure

    Primary Outcomes

    Description: The primary outcome is the proportion of patients who have a goals-of-care (GOC) discussion that has been documented in the EHR in the period between randomization and 30 days following randomization The proportion is the number of patients with GOC documentation over the number of patients in each study arm. Documentation of goals-of-care discussions will be evaluated using our NLP/ML methods. Study staff will manually review and compare findings using a randomly-selected sample of charts using our standard EHR abstraction methods; manual chart abstraction will be the gold standard.

    Measure: EHR documentation of Goals of Care discussions

    Time: Assessed for the period between randomization and 30 days following randomization

    Secondary Outcomes

    Description: Secondary outcomes include measures of intensity of care, including utilization metrics: Number of ICU admissions during the patient's (index) hospital stay will be collected from the EHR using our automated and validated methods.

    Measure: Intensity of care/ICU use: ICU admissions

    Time: Assessed for the period between randomization and 30 days following randomization

    Description: Secondary outcomes include measures of intensity of care, including utilization metrics: Number of days the patient spent in the ICU during their (index) hospital stay will be collected from the EHR using our automated and validated methods.

    Measure: Intensity of care/ICU use: ICU length of stay

    Time: Assessed for the period between randomization and 30 days following randomization

    Description: Secondary outcomes include measures of intensity of care, including utilization metrics: Number of days the patient spent in the hospital during that (index) hospital stay will be collected from the EHR using our automated and validated methods.

    Measure: Intensity of care/Hospital use: Hospital length of stay

    Time: Assessed for the period between randomization and 30 days following randomization

    Description: Secondary outcomes include measures of intensity of care, including utilization metrics: Number of hospital readmissions between randomization and 30 days following randomization will be collected from the EHR using our automated and validated methods.

    Measure: Intensity of care: Hospital Readmissions 30 days

    Time: Assessed for the period between randomization and 30 days following randomization

    Description: Secondary outcomes include measures of intensity of care, including utilization metrics: Number of ICU readmissions between randomization and 30 days following randomization will be collected from the EHR using our automated and validated methods.

    Measure: Intensity of care: ICU Readmissions 30 days

    Time: Assessed for the period between randomization and 30 days following randomization

    Description: Costs for intervention vs. control will be reported in US dollars and identified from UW Medicine administrative financial databases. Costs will be reported for total hospital costs and disaggregated costs (direct-variable, direct fixed, indirect costs). Direct-variable costs will include supply and drug costs. Direct-fixed costs will include labor, clinical department administration, and overhead fees. Indirect costs represent services provided by cost centers not directly linked to patient care such as information technology and environmental services. Costs for ED (emergency department) days and ICU days will be similarly assessed.

    Measure: Intensity of care: Healthcare costs

    Time: 1 and 3 months after randomization

    Description: From Washington State death certificates.

    Measure: All-cause mortality at 1 year (safety outcome)

    Time: 1 year after randomization

    Other Outcomes

    Description: Qualitative interviews after individual participation. Interviews will be guided by the RE-AIM and Consolidated Framework for Implementation Research (CFIR) to explore the factors associated with implementation (e.g., reach, maintenance, feasibility, inner and outer settings, individuals, and processes of care.) Individual constructs within these domains were chosen to fit this specific intervention and context.

    Measure: Key Implementation Factors

    Time: 3 months after randomization
    4 Antistof Respons Mod SARS-CoV-2 Hos Dialysepatienter i Forbindelse Med COVID-19

    Determination of IgM and IgG antibodies against SARS-CoV-2 in dialysis patients by continous monitoring in the period from March 2020 to december 2020

    NCT04367714
    Conditions
    1. COVID
    2. Terminal Renal Insufficiency
    MeSH:Renal Insufficiency
    HPO:Renal insufficiency

    Primary Outcomes

    Description: IgM and IgG against SARS-CoV-2

    Measure: AAntibody response

    Time: 1 year
    5 A Single Dose, Non-Randomized, Open-Label, Parallel Group Study to Assess the Pharmacokinetics, Safety and Tolerability of AZD9977 in Participants With Renal Impairment

    This is a single dose, non-randomized, open-label, parallel group study. The study will be conducted in participants with severe renal impairment and compared with matched participants with normal renal function. The duration of the study for an individual participant from Screening to Follow-up will be approximately 5 weeks.

    NCT04469907
    Conditions
    1. Renal Impairment
    Interventions
    1. Drug: AZD9977
    MeSH:Renal Insufficiency
    HPO:Renal insufficiency

    Primary Outcomes

    Description: To assess the PK of AZD9977 following administration of AZD9977

    Measure: Maximum observed plasma concentration (Cmax)

    Time: Day 1 to 3 (Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 16, 20, 24, 36, and 48 hours post-dose), Day 4 to 7

    Description: To assess the PK of AZD9977 following administration of AZD9977

    Measure: Area under the plasma concentration-time curve from time zero to infinity (AUC)

    Time: Day 1 to 3 (Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 16, 20, 24, 36, and 48 hours post-dose), Day 4 to 7

    Description: To assess the PK of AZD9977 following administration of AZD9977

    Measure: Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC0-t)

    Time: Day 1 to 3 (Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 16, 20, 24, 36, and 48 hours post-dose), Day 4 to 7

    Description: To assess the PK of AZD9977 following administration of AZD9977

    Measure: Time to reach maximum observed plasma concentration (tmax)

    Time: Day 1 to 3 (Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 16, 20, 24, 36, and 48 hours post-dose), Day 4 to 7

    Description: To assess the PK of AZD9977 following administration of AZD9977

    Measure: Half-life associated with terminal slope of a semi-logarithmic concentration time curve (t½λz)

    Time: Day 1 to 3 (Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 16, 20, 24, 36, and 48 hours post-dose), Day 4 to 7

    Description: To assess the PK of AZD9977 following administration of AZD9977

    Measure: Terminal elimination rate constant (λz)

    Time: Day 1 to 3 (Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 16, 20, 24, 36, and 48 hours post-dose), Day 4 to 7

    Description: To assess the PK of AZD9977 following administration of AZD9977

    Measure: Apparent total body clearance of drug from plasma after extravascular administration (CL/F)

    Time: Day 1 to 3 (Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 16, 20, 24, 36, and 48 hours post-dose), Day 4 to 7

    Description: To assess the PK of AZD9977 following administration of AZD9977

    Measure: Non-renal clearance of drug from plasma after oral administration (CLNR/F)

    Time: Day 1 to 3 (Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 16, 20, 24, 36, and 48 hours post-dose), Day 4 to 7

    Description: To assess the PK of AZD9977 following administration of AZD9977

    Measure: Apparent volume of distribution during the terminal phase after extravascular administration (Vz/F)

    Time: Day 1 to 3 (Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 16, 20, 24, 36, and 48 hours post-dose), Day 4 to 7

    Description: To assess the PK of AZD9977 following administration of AZD9977

    Measure: Mean residence time (MRT)

    Time: Day 1 to 3 (Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 16, 20, 24, 36, and 48 hours post-dose), Day 4 to 7

    Description: To assess the PK of AZD9977 following administration of AZD9977

    Measure: Renal clearance of the drug from plasma (CLR)

    Time: Day 1 to 3 (Pre-dose, 0-4, 4-8, 8-12, and 12-24 hours post-dose), Day 4 to 7

    Description: To assess the PK of AZD9977 following administration of AZD9977

    Measure: Cumulative amount of unchanged drug excreted into the urine (Ae)

    Time: Day 1 to 3 (Pre-dose, 0-4, 4-8, 8-12, and 12-24 hours post-dose), Day 4 to 7

    Description: To assess the PK of AZD9977 following administration of AZD9977

    Measure: Fraction of the drug excreted into the urine (fe)

    Time: Day 1 to 3 (Pre-dose, 0-4, 4-8, 8-12, and 12-24 hours post-dose), Day 4 to 7

    Secondary Outcomes

    Description: To evaluate the safety and tolerability of AZD9977

    Measure: Number of participants with adverse events and serious adverse events

    Time: Day -2 to Day 14

    Description: To determine eGFR based on creatinine and cystatin C using CKD-EPI formula

    Measure: Estimated Glomerular Filtration Rate (eGFR)

    Time: Screening, Day -1, Day 1 to 3 (Pre-dose, 4, 12, 24 , 36, and 48 hours)
    6 Global Assessment of Acute and Chronic Kidney Disease Incidence and Outcomes in Patients With COVID-19 Infection

    The coronavirus (COVID-19) pandemic has created a significant strain on health care resources across the world for managing critically ill patients. Emerging reports from China, South Korea and Italy have reported varying incidence of acute kidney (AKI) ranging from 5-15% with a mortality of 60-80% however there is no systematic assessment of the risk factors, recognition, course and outcomes in patients with and without kidney disease whose course is complicated by AKI1-4. Patients with underlying CKD, immunosuppressed patients with renal transplants and ESKD patients are at high risk for COVID-19 infection and there is limited information on the effect of COVID-19 on the course and outcomes of these patients. The requirement for renal support including IHD, CRRT and sorbent based therapies has been variable and has contributed to the intense pressure on the nephrology and critical care providers for delivering these therapies. As the COVID-19 pandemic expands in the USA and abroad, there is an intense need to understand the epidemiology of the disease and the resources needed for renal support to inform clinical management and public health interventions. In this study, the investigators aim to investigate health care facilities across the world (hospital wards, ICU, outpatient clinics, nursing homes, healthcare centers) to draw a global picture of incidence, risk factors, resources available for treatment and prognosis of acute and chronic kidney disease in patient with COVID 19 confirmed infection. The aim is to identify trends in patients with acute and chronic kidney disease, determine its incidence, treatment and outcomes in different settings across the world. This information will be used to develop and implement educational tools and resources to prevent deaths from AKI and progression of CKD in this and following pandemics.

    NCT04491227
    Conditions
    1. Covid19
    2. AKI
    3. CKD
    4. ESRD
    5. Transplant;Failure,Kidney
    MeSH:Kidney Diseases Renal Insufficiency, Chronic Renal Insufficiency
    HPO:Abnormality of the kidney Chronic kidney disease Nephropathy Renal insufficiency

    Primary Outcomes

    Description: Meeting of at least one of the modified KDIGO Criteria Increase or decrease in serum creatinine >0.3 mg/dl from reference in 48 hours Increase or decrease in serum creatinine > 50% from reference in 7 days Urine output < 400 ml/day

    Measure: AKI incidence

    Time: from hospital admission through hospital discharge upto 24 weeks

    Description: initiation of intermittent hemodialysis, continuous hemodialysis or peritoneal dialysis during the hospital stay

    Measure: Dialysis requirement

    Time: through study completion upto 1 year from enrollment

    Description: Deaths during primary hospitalization

    Measure: hospital mortality

    Time: through study completion within 1 year

    Secondary Outcomes

    Description: C-Complete: SCr < 0.3 mg/dL from reference P-Partial: Requires no dialysis but not complete recovery N-No recovery: Dialysis dependent C-Complete: SCr < 0.3 mg/dL from reference P-Partial: Requires no dialysis but not complete recovery N-No recovery: Dialysis dependent Percentage of patinets with renal functioanl recovery based on serum creatinien levels classfied as C-Complete: SCr < 0.3 mg/dL from reference P-Partial: Requires no dialysis but not complete recovery N-No recovery: Dialysis dependent

    Measure: Renal functional recovery

    Time: Assessed at at 3, 6 and 12 months from enrollment at hospital admission

    Description: EQL5D scale and SH8 scales completed at 3, 6 and 12 months post enrollment

    Measure: Functional status

    Time: questionnaires to be completed at 3, 6 and 12 months from enrollment at hospital admission

    Description: Number of days patient is in the hospital and ICU and is managed with ventilators, dialysis or other extracorporeal organ support e.g. ECMO during the hospital stay

    Measure: Resource utilization

    Time: Within 1 year of enrollment for primary hospitalization
    7 OPEN-LABEL, SINGLE-DOSE, PARALLEL GROUP STUDY TO EVALUATE THE PHARMACOKINETICS OF PF-06882961 IN PARTICIPANTS WITH TYPE 2 DIABETES MELLITUS WITH VARYING DEGREES OF RENAL IMPAIRMENT RELATIVE TO PARTICIPANTS WITHOUT RENAL IMPAIRMENT

    This study will characterize the effect of varying degrees of renal impairment on the pharmacokinetics (PK), safety and tolerability of a single oral dose of PF- 06882961 compared with participants with normal renal function.

    NCT04616027
    Conditions
    1. Diabetes Mellitus, Type 2
    2. Renal Impairment
    3. Healthy
    Interventions
    1. Drug: PF-06882961 20 mg
    MeSH:Renal Insuffici Renal Insufficiency Diabetes Mellitus Diabetes Mellitus, Type 2
    HPO:Diabetes mellitus Renal insufficiency Type II diabetes mellitus

    Primary Outcomes

    Measure: Maximum plasma concentration [C(max)]

    Time: Hour 0, 1, 2, 3, 4, 5, 6, 8, 10, 12, and 16 on Day 1, Hour 24 and 36 on Day 2, Hour 48 on Day 3

    Measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC(inf)]

    Time: Hour 0, 1, 2, 3, 4, 5, 6, 8, 10, 12, and 16 on Day 1, Hour 24 and 36 on Day 2, Hour 48 on Day 3

    Measure: Area under the plasma concentration-time [AUC(last)]

    Time: Hour 0, 1, 2, 3, 4, 5, 6, 8, 10, 12, and 16 on Day 1, Hour 24 and 36 on Day 2, Hour 48 on Day 3

    Measure: Fraction of unbound drug in plasma [fu]

    Time: Hour 0, 1, 2, 3, 4, 5, 6, 8, 10, 12, and 16 on Day 1, Hour 24 and 36 on Day 2, Hour 48 on Day 3

    Secondary Outcomes

    Measure: Unbound Maximum Observed Plasma Concentration [C(max,u)]

    Time: Hour 0 and 4 on Day 1

    Measure: Unbound area under the plasma concentration-time profile from time zero extrapolated to infinite time [AUC(inf,u)]

    Time: Hour 0 and 4 on Day 1

    Measure: Unbound area under the plasma concentration time profile from time zero to the time of the last quantifiable concentration [AUC[last,u])

    Time: Hour 0 and 4 on Day 1

    Measure: Apparent Oral Clearance [CL/F]

    Time: Hour 0 and 4 on Day 1

    Measure: Apparent clearance of unbound drug [CL(u)/F]

    Time: Hour 0 and 4 on Day 1

    Measure: Apparent volume of distribution [V(z)/F]

    Time: Hour 0 and 4 on Day 1

    Measure: Time to Reach Maximum Observed Plasma Concentration [T(max)]

    Time: Hour 0 and 4 on Day 1

    Measure: Time measured for plasma concentration to decrease by one half (Terminal half-life) [t(1/2)].

    Time: Hour 0 and 4 on Day 1

    Measure: Incidence and severity of treatment emergent adverse events (AEs and SAEs)

    Time: Baseline through Day 28

    Measure: Incidence of treatment emergent clinical laboratory abnormalities

    Time: Baseline to Day 3

    Measure: Incidence of treatment emergent vital signs

    Time: Baseline, Day 1 and Day 3

    Measure: Incidence of treatment emergent Electrocardiogram [ECG] abnormalities

    Time: Baseline, Day 1 and Day 3
    8 Randomized Parallel Group Study Comparing the Renal Safety of CAPTISOL-Enabled™ Iohexol (CE-Iohexol) Injection and Omnipaque™ (Iohexol) Injection in Patients With Impaired Renal Function Undergoing Coronary Angiography

    Randomized parallel group study comparing the renal safety of Captisol-Enabled™ Iohexol (CE-Iohexol) Injection and Omnipaque™ (Iohexol) Injection in patients with impaired renal function undergoing coronary angiography.

    NCT04627831
    Conditions
    1. Contrast-induced Nephropathy
    Interventions
    1. Drug: CE-Iohexol
    2. Drug: Iohexol
    MeSH:Renal Insufficiency
    HPO:Renal insufficiency

    Primary Outcomes

    Description: Evaluate the incidence of CI-AKI in patients with impaired renal function undergoing coronary angiography, from baseline to any blood draw within 7 days following intravascular administration of CE-iohexol compared with Omnipaque (iohexol).

    Measure: Incidence of contrast-induced acute kidney injury (CI-AKI)

    Time: 7 days

    Description: Compare image quality of coronary angiography in patients administered CE-iohexol versus iohexol as assessed quantitatively using a Visual Analog Scale (VAS).

    Measure: Image quality

    Time: Day 1

    Secondary Outcomes

    Description: Evaluate the changes in SCr in patients administered CE-iohexol versus iohexol.

    Measure: Change in serum creatinine (SCr)

    Time: 7 days

    Description: Evaluate the proportion of patients exhibiting an increase in SCr following intravascular administration of CE-iohexol compared with iohexol.

    Measure: Proportion of patients exhibiting an increase in SCr

    Time: 7 days

    Description: The number of patients with adverse events (AE) and severe adverse events will be assessed and graded according to Common Terminology Criteria for Adverse Events (CTCAE) v 4.0. Monitoring for Major Adverse Cardiac and Renal Events (MARCEs) will be part of the AE assessment.

    Measure: Incidence of Adverse Events

    Time: 30 days

    Description: Evaluate the changes in serum cystatin C in patients administered CE-iohexol versus iohexol.

    Measure: Change in serum cystatin C

    Time: 7 days

    Description: Compare image quality of coronary angiography in patients administered CE-iohexol versus iohexol as assessed by the investigator using qualitative methods.

    Measure: Investigator Assessed Image Quality

    Time: Day 1

    Other Outcomes

    Description: Evaluate the change in blood and urine biomarkers of renal injury from baseline to peak at 48 hours in patients administered CE-iohexol versus iohexol. Biomarkers may include neutrophil gelatinase-associated lipocalin, liver-type fatty acid binding protein, and kidney injury molecule-1.

    Measure: Change in novel biomarkers of renal injury

    Time: 7 days
    9 A Single Dose, Non-Randomized, Open-Label, Parallel Group Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics, Safety and Tolerability of MT-7117 in Subjects With Renal Impairment Compared to Subjects With Normal Renal Function

    This is an open-label, non randomised, single-dose, study in male and female subjects with renal impairment (severe and if required mild & moderate) compared to male and female subjects with normal renal function.

    NCT04656795
    Conditions
    1. Renal Impairment
    2. Normal Renal Function
    Interventions
    1. Drug: MT-7117
    MeSH:Renal Insufficiency
    HPO:Renal insufficiency

    Primary Outcomes

    Measure: Maximum observed plasma concentration (Cmax) of MT-7117

    Time: Day 1 to 4

    Measure: Area under the plasma concentration time curve from time zero to the last quantifiable concentration (AUC0-last) of MT-7117

    Time: Day 1 to 4

    Measure: Area under the plasma concentration time curve from time zero to infinity (AUC0-∞) of MT-7117

    Time: Day 1 to 4

    Secondary Outcomes

    Measure: Safety and tolerability as measured by incidence of Treatment emergent adverse events

    Time: Day -1 to Day 8

    Measure: Time to maximum plasma concentration (tmax) of MT-7117

    Time: Day 1 to 4

    Measure: Apparent elimination half-time of MT-7117 in plasma (t1/2)

    Time: Day 1 to 4

    Measure: Apparent oral clearance (CL/F) of MT-7117in plasma

    Time: Day 1 to 4

    Measure: Apparent volume of distribution during the terminal phase (Vz/F) of MT-7117in plasma

    Time: Day 1 to 4

    Measure: Unbound fraction (fu) of MT-7117 in plasma

    Time: Day 1 to 4

    Measure: Maximum observed unbound plasma concentration (Cmax,u) of MT-7117 of MT-7117

    Time: Day 1 to 4

    Measure: Area under the unbound plasma concentration time curve from time zero to the last quantifiable concentration (AUC0-last, u) of MT-7117

    Time: Day 1 to 4

    Measure: Area under the unbound plasma concentration time curve from time zero to infinity (AUC0-∞, u)of MT-7117

    Time: Day 1 to 4

    HPO Nodes


    HP:0000083: Renal insufficiency
    Genes 451
    LHX1 LCAT ALOXE3 SH2B1 WT1 PGAM2 FN1 COL7A1 GTF2IRD1 MME GSN ERCC6 NTRK1 OSGEP FANCM TBX18 IKZF1 CTNS GRHPR IFT140 CACNA1S PAX2 IFT172 FXYD2 NPHP3 TCF4 SHPK HLA-DPA1 SCNN1G CEP164 RAD51C SLC30A9 FUZ TMEM67 OCRL PRDX1 ABCA12 MUC1 KYNU ARHGDIA NLRP3 DYNC2H1 CLIP2 ELN PKD1 NPHP1 CEP290 BRIP1 IRF5 LMX1B WT1 TGM1 ELN MYD88 CLCNKB NPHP1 ERCC8 FANCG HLA-DPB1 CFHR5 CFHR1 WDR19 SDCCAG8 LIPN CRB2 PKHD1 UMOD COQ8B PPOX SIX5 ACTN4 CC2D2A NOD2 SCNN1B AP2S1 CEP83 PAX2 HNF1B CTLA4 IFT122 CLCNKA PRKCD SLC7A7 CPT2 CCR6 DNAJB11 CLCN5 DACT1 CD46 WT1 PKD2 GLA TTC21B PKD2 FANCD2 CFI TMEM67 MYOCD SMARCAL1 MEN1 RMND1 PUS3 STAT2 FAH CEP290 PYGM FAN1 TMEM67 UMOD ERCC8 TPRKB OCRL SLC7A9 BBS10 FANCL MAGI2 FAS ALDOB GSN IQCB1 PRTN3 MEFV HRAS HPSE2 MYCN NUP160 AGXT NUP85 DZIP1L CAV1 ALOX12B C3 TMEM260 BBIP1 RYR1 ELP1 UMOD KMT2A FANCF WDR73 NPHP3 IFT80 SPRY2 CASP10 GATA3 DGKE SCNN1A IFT140 DSTYK C4A NPHP4 GATM LRIG2 CHRNA3 AGXT PGK1 GATA3 LDHA CYP4F22 ERCC8 CHRM3 MEFV NPHP3 TRNE WT1 CD2AP KCTD1 TRAF3IP1 TTC21B TMEM231 HMBS GLA MMACHC KIAA0586 FANCI NUP107 SPP1 XPNPEP3 PTPN22 PKD1 RAD21 ALMS1 CHD4 CDC73 IFT43 COL4A1 MAFB FN1 PTPN22 ACP5 DHDDS SLC3A1 ERCC4 LEMD3 HNF4A CLDN10 DNASE1L3 RASGRP1 FANCA STS MOCOS PRKCD LRIG2 NPHP4 IL12A-AS1 COG1 BICC1 PEX7 CCN2 TTC21B GANAB VANGL1 IL12A LAMB2 TSC2 WDR19 MMUT CLDN16 CFB HNF1B NIPBL HOXA13 PHYH COL4A5 SLC37A4 CFI NPHP4 MYCN SOX18 FAM20A INVS DYNC2LI1 NPHP3 COL4A3 EIF2AK3 APC2 RPGRIP1L SCARB2 LMX1B ZNF423 THBD GLIS2 CLCN5 WDR73 NSD1 SULT2B1 DYNC2I1 MMUT SDR9C7 TMEM237 PBX1 PALB2 TMEM231 TRNK OCLN TBL2 GRHPR IL10 WDR19 SDCCAG8 FANCE IFT172 EHMT1 CTNS CORIN CCNQ SLC34A1 CEP120 RFC2 SLC22A12 NPHS2 HPRT1 SGPL1 GCDH FANCC LIMK1 ZNF592 ITGA3 APOE NPHP1 FLT1 TRNT BRCA1 MYH9 SAA1 MYO1E CCND1 IQCB1 MAPKBP1 STAT4 PKHD1 CD151 MST1 ANKS6 BRCA2 NPHP1 MMACHC LPIN1 NUP107 PRPS1 FASLG NDUFAF6 AVPR2 TRAF3IP1 TMEM216 STOX1 CFH LAMB2 C3 NPHS1 IL23R CLCN5 APRT OFD1 TMEM126B MAD2L2 AMMECR1 DCDC2 NUP205 PNPLA6 TMEM237 CFH FANCB ANLN CLCN5 HLA-B SIX5 SLX4 TSC1 ALMS1 GCM2 TLR4 WT1 PAX6 RPGRIP1L AQP2 CFH TBC1D8B COL4A1 SIX1 PKDCC MEFV NEK8 HBB BSND LAGE3 CFI FAS HPS1 HNF1B APRT NOTCH2 UBE2T SCNN1B GTF2I SLC26A1 STAT4 LMX1B ERCC6 IRAK1 EIF2AK3 CLPB HPRT1 SETD5 AHI1 CSPP1 CCR1 UBAC2 PAX2 COL4A3 WDR35 TMEM138 SALL1 FAS SMC1A CFHR3 SETD2 ERCC4 RAD51 OCRL DZIP1L MMUT NPHP1 CDC73 SMC3 BNC2 XRCC2 TP53RK BICC1 ERAP1 ERCC6 CDC73 INF2 WDR19 APOL1 INF2 HLA-DRB1 IFT27 CPT2 PRPS1 CEP290 JAG1 CPT2 TMEM67 SARS2 PGK1 TCN2 HDAC8 RFWD3 COL4A4 CEP290 AVIL ACSL4 EYA1 HPRT1 KLRC4 RAD51C TRPC6 PLCE1 MMP1 MLXIPL CC2D2A FAM20A LZTFL1 MDM2 HLA-DRB1 WDR19 INPP5E AMMECR1 REN DYNC2I2 HELLPAR NUP133 NUP93 GPR35 BAZ1B ERCC4 KCNE5 SEC61A1 CPT2 HSD11B2 NIPAL4 TMEM67 CD46 CTNS SALL1 CLDN19 BTNL2 INVS HLA-B TRNL1
    Protein Mutations 2
    L31F Y93H
    SNP 0

    HPO

    Alphabetical listing of all HPO terms. Navigate: Correlations   Clinical Trials


    HPO Nodes


    HP:0000083: Renal insufficiency
    Genes 451
    LHX1 LCAT ALOXE3 SH2B1 WT1 PGAM2 FN1 COL7A1 GTF2IRD1 MME GSN ERCC6 NTRK1 OSGEP FANCM TBX18 IKZF1 CTNS GRHPR IFT140 CACNA1S PAX2 IFT172 FXYD2 NPHP3 TCF4 SHPK HLA-DPA1 SCNN1G CEP164 RAD51C SLC30A9 FUZ TMEM67 OCRL PRDX1 ABCA12 MUC1 KYNU ARHGDIA NLRP3 DYNC2H1 CLIP2 ELN PKD1 NPHP1 CEP290 BRIP1 IRF5 LMX1B WT1 TGM1 ELN MYD88 CLCNKB NPHP1 ERCC8 FANCG HLA-DPB1 CFHR5 CFHR1 WDR19 SDCCAG8 LIPN CRB2 PKHD1 UMOD COQ8B PPOX SIX5 ACTN4 CC2D2A NOD2 SCNN1B AP2S1 CEP83 PAX2 HNF1B CTLA4 IFT122 CLCNKA PRKCD SLC7A7 CPT2 CCR6 DNAJB11 CLCN5 DACT1 CD46 WT1 PKD2 GLA TTC21B PKD2 FANCD2 CFI TMEM67 MYOCD SMARCAL1 MEN1 RMND1 PUS3 STAT2 FAH CEP290 PYGM FAN1 TMEM67 UMOD ERCC8 TPRKB OCRL SLC7A9 BBS10 FANCL MAGI2 FAS ALDOB GSN IQCB1 PRTN3 MEFV HRAS HPSE2 MYCN NUP160 AGXT NUP85 DZIP1L CAV1 ALOX12B C3 TMEM260 BBIP1 RYR1 ELP1 UMOD KMT2A FANCF WDR73 NPHP3 IFT80 SPRY2 CASP10 GATA3 DGKE SCNN1A IFT140 DSTYK C4A NPHP4 GATM LRIG2 CHRNA3 AGXT PGK1 GATA3 LDHA CYP4F22 ERCC8 CHRM3 MEFV NPHP3 TRNE WT1 CD2AP KCTD1 TRAF3IP1 TTC21B TMEM231 HMBS GLA MMACHC KIAA0586 FANCI NUP107 SPP1 XPNPEP3 PTPN22 PKD1 RAD21 ALMS1 CHD4 CDC73 IFT43 COL4A1 MAFB FN1 PTPN22 ACP5 DHDDS SLC3A1 ERCC4 LEMD3 HNF4A CLDN10 DNASE1L3 RASGRP1 FANCA STS MOCOS PRKCD LRIG2 NPHP4 IL12A-AS1 COG1 BICC1 PEX7 CCN2 TTC21B GANAB VANGL1 IL12A LAMB2 TSC2 WDR19 MMUT CLDN16 CFB HNF1B NIPBL HOXA13 PHYH COL4A5 SLC37A4 CFI NPHP4 MYCN SOX18 FAM20A INVS DYNC2LI1 NPHP3 COL4A3 EIF2AK3 APC2 RPGRIP1L SCARB2 LMX1B ZNF423 THBD GLIS2 CLCN5 WDR73 NSD1 SULT2B1 DYNC2I1 MMUT SDR9C7 TMEM237 PBX1 PALB2 TMEM231 TRNK OCLN TBL2 GRHPR IL10 WDR19 SDCCAG8 FANCE IFT172 EHMT1 CTNS CORIN CCNQ SLC34A1 CEP120 RFC2 SLC22A12 NPHS2 HPRT1 SGPL1 GCDH FANCC LIMK1 ZNF592 ITGA3 APOE NPHP1 FLT1 TRNT BRCA1 MYH9 SAA1 MYO1E CCND1 IQCB1 MAPKBP1 STAT4 PKHD1 CD151 MST1 ANKS6 BRCA2 NPHP1 MMACHC LPIN1 NUP107 PRPS1 FASLG NDUFAF6 AVPR2 TRAF3IP1 TMEM216 STOX1 CFH LAMB2 C3 NPHS1 IL23R CLCN5 APRT OFD1 TMEM126B MAD2L2 AMMECR1 DCDC2 NUP205 PNPLA6 TMEM237 CFH FANCB ANLN CLCN5 HLA-B SIX5 SLX4 TSC1 ALMS1 GCM2 TLR4 WT1 PAX6 RPGRIP1L AQP2 CFH TBC1D8B COL4A1 SIX1 PKDCC MEFV NEK8 HBB BSND LAGE3 CFI FAS HPS1 HNF1B APRT NOTCH2 UBE2T SCNN1B GTF2I SLC26A1 STAT4 LMX1B ERCC6 IRAK1 EIF2AK3 CLPB HPRT1 SETD5 AHI1 CSPP1 CCR1 UBAC2 PAX2 COL4A3 WDR35 TMEM138 SALL1 FAS SMC1A CFHR3 SETD2 ERCC4 RAD51 OCRL DZIP1L MMUT NPHP1 CDC73 SMC3 BNC2 XRCC2 TP53RK BICC1 ERAP1 ERCC6 CDC73 INF2 WDR19 APOL1 INF2 HLA-DRB1 IFT27 CPT2 PRPS1 CEP290 JAG1 CPT2 TMEM67 SARS2 PGK1 TCN2 HDAC8 RFWD3 COL4A4 CEP290 AVIL ACSL4 EYA1 HPRT1 KLRC4 RAD51C TRPC6 PLCE1 MMP1 MLXIPL CC2D2A FAM20A LZTFL1 MDM2 HLA-DRB1 WDR19 INPP5E AMMECR1 REN DYNC2I2 HELLPAR NUP133 NUP93 GPR35 BAZ1B ERCC4 KCNE5 SEC61A1 CPT2 HSD11B2 NIPAL4 TMEM67 CD46 CTNS SALL1 CLDN19 BTNL2 INVS HLA-B TRNL1
    Protein Mutations 2
    L31F Y93H
    SNP 0

    Reports

    Data processed on December 13, 2020.

    An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.

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    706 reports on MeSH terms

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    306 reports on HPO terms

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