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Report for D051437: Renal Insufficiency NIH

(Synonyms: Renal I, Renal In, Renal Ins, Renal Insu, Renal Insuf, Renal Insuff, Renal Insuffi, Renal Insuffic, Renal Insufficie, Renal Insufficien, Renal Insufficienc, Renal Insufficiency, Renal Insufficiency,, Renal Insufficiency,)

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (4)

Name (Synonyms) Correlation
drug300 BMS-986259 Wiki 0.50
drug762 Diet tracking and survey Wiki 0.50
drug809 EHR-based Clinician Jumpstart Wiki 0.50
drug2413 TAK-788 Wiki 0.29

Correlated MeSH Terms (13)

Name (Synonyms) Correlation
D014652 Vascular Diseases NIH 0.35
D016491 Peripheral Vascular Diseases NIH 0.35
D058729 Peripheral Arterial Disease NIH 0.29
D009362 Neoplasm Metastasis NIH 0.29
D008175 Lung Neoplasms NIH 0.25
D008103 Liver Cirrhosis, NIH 0.25
D007676 Kidney Failure, Chronic NIH 0.20
D006333 Heart Failure NIH 0.19
D029424 Pulmonary Disease, Chronic Obstructive NIH 0.18
D017563 Lung Diseases, Interstitial NIH 0.16
D002908 Chronic Disease NIH 0.16
D008171 Lung Diseases, NIH 0.13
D009369 Neoplasms, NIH 0.11

Correlated HPO Terms (9)

Name (Synonyms) Correlation
HP:0000083 Renal insufficiency HPO 1.00
HP:0001395 Hepatic fibrosis HPO 0.25
HP:0100526 Neoplasm of the lung HPO 0.25
HP:0004950 Peripheral arterial stenosis HPO 0.22
HP:0001635 Congestive heart failure HPO 0.19
HP:0006510 Chronic pulmonary obstruction HPO 0.18
HP:0006515 Interstitial pneumonitis HPO 0.16
HP:0002088 Abnormal lung morphology HPO 0.13
HP:0002664 Neoplasm HPO 0.11

There are 4 clinical trials

Clinical Trials

1 A Phase 1 Pharmacokinetic Study of Oral TAK-788 in Participants With Severe Renal Impairment and Normal Renal Function

The purpose of this study is to characterize the single-dose plasma and urine PK of TAK-788 and its active metabolites (AP32960 and AP32914) in participants with severe RI compared to matched-healthy participants with normal renal function.

NCT04056455 Renal Impairment Healthy Volunteers Drug: TAK-788
MeSH:Renal Insufficiency
HPO:Renal insufficiency

Primary Outcomes

Measure: Cmax: Maximum Observed Plasma Concentration for TAK-788 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 TAK-788 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 TAK-788 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 TAK-788 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 TAK-788 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 TAK-788 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 TAK-788 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 TAK-788 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 TAK-788 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 TAK-788 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 TAK-788 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 TAK-788 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 TAK-788

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 TAK-788

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 TAK-788

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 TAK-788

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 TAK-788 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 TAK-788 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 TAK-788 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 TAK-788 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 Renal Failure 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 Dementia Chronic Disease Neoplasm Metastasis Lung Neoplasm Pulmonary Disease, Chronic Obstructive Heart Failure，Congestive Liver Cirrhosis Kidney Failure, Chronic Lung Diseases, Interstitial Peripheral Vascular Disease Diabetes With End Organ Injury Palliative Care, Patient Care Health Care Quality, Access, and Evaluation Patient Care Inpatients Health Communication Patient Care Planning Behavioral: EHR-based Clinician Jumpstart
MeSH: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 Neoplasms
HPO:Abnormal lung morphology Chronic pulmonary obstruction Cirrhosis Congestive heart failure Hepatic fibrosis Interstitial pneumonitis Interstitial pulmonary abnormality Left ventricular dysfunction 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 COVID 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

HPO Nodes

HP:0000083: Renal insufficiency
Genes 432
GATM DYNC2LI1 SMARCAL1 TMEM231 TMEM231 LIMK1 SDCCAG8 GRHPR TSC2 STS AMMECR1 FAN1 LPIN1 FANCL MAGI2 NPHP4 CLCN5 OCRL PEX7 SIX5 MEFV ELN IL12A-AS1 CASP10 CTLA4 NUP160 CC2D2A BRIP1 IFT27 GPR35 TMEM138 GATA3 FXYD2 SAA1 GLA UMOD CCR1 CCR6 ZNF592 CLCN5 KLRC4 ERCC8 CRB2 CFH AGXT LRIG2 IFT172 GRHPR HLA-B TCF4 TRNK MOCOS CFI CEP290 SLC7A7 HPRT1 HRAS CFI DSTYK SLC37A4 TRNT BSCL2 IFT43 MYD88 PHYH SLX4 CLDN16 DZIP1L CD46 OCLN WT1 FASLG NUP93 GCM2 RAD21 C4A CORIN RPGRIP1L NOD2 AQP2 KIAA0586 SCARB2 FANCA INVS ABCA12 MST1 GLA NPHS2 CLCN5 SCNN1A MAPKBP1 XRCC2 FOS CEP290 WDR19 WT1 OFD1 PUS3 FAM20A PAX2 NUP133 SPP1 TRAF3IP1 HLA-DPB1 OCRL UBE2T LZTFL1 TMEM216 DHDDS BNC2 MEN1 AGPAT2 LMX1B NPHP1 SMC1A GTF2IRD1 IFT80 PPARG FANCB FAS SLC22A12 TTC21B MYH9 IL12A SEC61A1 WT1 GSN FANCM RFC2 ERCC4 IQCB1 IRF5 ERCC6 SGPL1 CAV1 GANAB PKHD1 CC2D2A MUC1 EYA1 ERCC4 CD2AP CLIP2 COL4A3 HPSE2 PYGM DCDC2 STAT4 SLC34A1 IL23R SIX1 VANGL1 CFH CFI ERAP1 INF2 ITGA3 HBB MAFB CFH NLRP3 PKD2 BICC1 CFHR5 DNAJB11 CTNS BRCA2 CACNA1S NPHP1 CD151 TGM1 PAX6 CCND1 TMEM126B CFHR1 PAX2 RPGRIP1L PKD1 RAD51C PGAM2 BRCA1 IRAK1 CHRM3 CLDN10 PRTN3 WDR35 GSN EHMT1 HLA-B ELP1 ALMS1 ELN TRNL1 PNPLA6 MAD2L2 SULT2B1 IQCB1 WDR19 WDR19 NUP107 LCAT PRDX1 CAV1 TMEM67 CPT2 SPRY2 PBX1 KMT2A COL4A1 TRAF3IP1 TTC21B AGXT STOX1 LAMB2 LEMD3 BBS10 TMEM67 CTNS FAS MMUT C3 HNF1B ACTN4 COL7A1 IFT122 HSD11B2 TPRKB NPHP1 HDAC8 PALB2 LIPN SDR9C7 CEP120 PAX2 FANCE ACSL4 TMEM237 NOTCH2 TMEM67 NPHP1 IFT172 EIF2AK3 RFWD3 NPHP3 PGK1 NEK8 ALMS1 TRPC6 CPT2 CLCNKA LHX1 AVPR2 NIPBL HNF4A CYP4F22 SALL1 CHD4 AP2S1 SCNN1B SLC7A9 SCNN1B DYNC2I1 NPHP1 APRT ALDOB IFT140 TRNE LAGE3 FANCF HNF1B HNF1B IFT140 NPHP3 CC2D2A NUP85 TP53RK THBD MMUT LMX1B LRIG2 CPT2 SMC3 CEP290 HLA-DRB1 ANLN PGK1 XPNPEP3 FANCG FUZ COL4A3 NUP205 COG1 TMEM67 NIPAL4 MLXIPL HOXA13 APOE FLT1 SALL1 CFB NUP107 LAMB2 FANCI IKZF1 UBAC2 FAS PKD1 FANCD2 MMACHC LMX1B PLCE1 PTPN22 TCN2 SIX5 DGKE BAZ1B APOL1 CDC73 CLCNKB NPHP3 ALOXE3 PKD2 APRT HLA-DPA1 SHPK COL4A5 TLR4 CLPB CLCN5 RMND1 CAVIN1 ZNF423 REN RAD51 NPHP4 DYNC2H1 JAG1 FAM20A DACT1 MMUT PKHD1 BICC1 COL4A4 CPT2 WT1 FAH TBC1D8B INPP5E C3 WT1 GTF2I CEP83 TBX18 ANKS6 OCRL KYNU GLIS2 UMOD DNASE1L3 KCNE5 CDC73 IL10 TTC21B RASGRP1 NPHS1 STAT4 TMEM67 SH2B1 TMEM237 NPHP3 MEFV TMEM260 AHI1 COL4A1 CEP164 PRPS1 MEFV INVS RAD51C BTNL2 PTPN22 CEP290 SLC3A1 SDCCAG8 FN1 BBIP1 FN1 HPS1 RPGRIP1L SETD5 MYO1E COQ8B ALOX12B FANCC TSC1 TBL2 AMMECR1 HMBS DZIP1L RYR1 HELLPAR DYNC2I2 MME ARHGDIA KCTD1 GATA3 CCNQ WDR73 WDR19 CSPP1 CDC73 HLA-DRB1 LDHA NPHP4 CLDN19 UMOD CD46 HPRT1 EIF2AK3 SARS2 WDR19 HPRT1 PRKCD BSND CCN2 SCNN1G SLC30A9 SLC26A1 WDR73 CFHR3 OSGEP SOX18
Protein Mutations 2
L31F Y93H
SNP 0