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| Name (Synonyms) | Correlation | |
|---|---|---|
| drug4019 | Sodium Zirconium Cyclosilicate (SZC) Dose During 28 Day Maintenance Phase Wiki | 1.00 |
| drug4021 | Sodium Zirconium Cyclosilicate (SZC) Dose Level 2 (DL2) Wiki | 1.00 |
| drug4023 | Sodium Zirconium Cyclosilicate (SZC) Reduced Dose Level Wiki | 1.00 |
| Name (Synonyms) | Correlation |
|---|
Navigate: Correlations HPO
There is one clinical trial.
Sodium zirconium cyclosilicate has been shown to be effective and safe in adults for the treatment of hyperkalaemia, and therefore it is expected to be beneficial in children. This study will evaluate the efficacy, safety and tolerability of sodium zirconium cyclosilicate for the treatment of hyperkalaemia in children <18 years of age. Primary Objective:28-day maintenance phase (MP) primary objective: To compare the effect of SZC vs placebo on maintaining normokalaemia during the MP. Correction phase (CP) primary objective: To evaluate SZC efficacy of different dose levels on achieving normokalaemia during the CP. Overall design: Approximately 140 participants will be enrolled at approximately 40 sites in locations including but not limited to Europe and North America for this study. Treatment will include 3 phases: the CP, MP, and LTMP. Participants from 2 to <18 years are eligible to participate in all phases of the study. Participants <2 years of age will be included in the first 2 phases, namely the CP and the MP. During the study, participants are recommended to be fasting prior to any visit pre-dose laboratory testing. All laboratory tests are taken pre-dose except select post dose K+ values during the CP. Electrocardiograms are to be taken prior to dosing. On visit days, the study treatment is to be taken at the site (during the CP this pertains only to the morning dose). For participants with diabetes, K+ measurements should be performed prior to insulin administration where possible. For inclusion into the study and for determining the ≥0.5 mmol/L decrease in K+, i-STAT is used. For subsequent decisions on eligibility and determination of hyper and normokalaemia for entry into the MP and LTMP phases, local laboratory K+ is the determinant value. Tolerability and safety will be assessed using AE reporting, results from laboratory testing, vital signs, physical examinations and ECG findings during the study. Care will be taken not to introduce bias when detecting AEs and/or SAEs. Open ended non leading verbal questioning of the participant or participant's legal representative, as appropriate, is the preferred method to inquire about AE occurrences. Participants are allowed to discontinue the study treatment and assessments at any time or at the discretion of the Investigator(s). The independent Data Monitoring Committee (iDMC) will monitor data during all phases of the study including DL evaluations.
Description: The proportion of participants in whom normokalaemia can be maintained throughout the Maintenance phase.
Measure: 28-day maintenance phase (MP) primary endpoint (Primary Analysis Endpoint): The proportion of participants in whom normokalaemia can be maintained throughout the MP. Time: 28 DaysDescription: The proportion of participants in whom S-K+ decreases by ≥0.5 mmol/L and who achieve normokalaemia at (by or before) 24, 48 and 72 hours during Correction Phase.
Measure: Correction phase (CP) primary endpoint: The proportion of participants in whom S-K+ decreases by ≥0.5 mmol/L and who achieve normokalaemia at (by or before) 24, 48 and 72 hours during Correction Phase. Time: 24, 48 and 72 HoursDescription: The proportion of participants in whom S-K+ decreases by ≥0.5 mmol/L and who achieve normokalaemia during the first 72 hours.
Measure: Correction Phase secondary endpoints The proportion of participants in whom S-K+ decreases by ≥0.5 mmol/L and who achieve normokalaemia during the first 72 hours Time: 72 hoursDescription: Time from randomisation to relapse of hyperkalaemia in each treatment group
Measure: Maintenance Phase secondary endpointsTime from randomization to relapse of hyperkalaemia.: Time: 28 DaysDescription: Proportion of participants within each treatment group who maintain normokalaemia per visit over the MP
Measure: Maintenance Phase Secondary endpoint. Proportion of participants within each treatment group who maintain normal S-K+ levels . Time: 28 daysDescription: Absolute change from baseline in S-K+ levels post dose during the MP and at any time point thereafter in each treatment group
Measure: Maintenance Phase Secondary End Point. Absolute change from base line in S-K+ levels post dose during MP and at any time point thereafter in each treatment group. Time: 28 daysDescription: Time to an increase in S-K+ concentration of ≥0.5 mmol/L in each treatment group
Measure: Maintenance Phase Secondary End Point. Time to an increase in S-K+ concentration of 0.5 mmol/L in each treatment group. Time: 28 DaysDescription: The difference in mean of all S-K+ values obtained during the MP in participants receiving either SZC or placebo
Measure: Maintenance Phase Secondary End point. The difference in mean of all S-K values obtained during the MP in subjects receiving either SZC or placebo. Time: 28 DaysDescription: The number and percentage of participants with hypo- or hyperkalaemia in participants receiving either SZC or placebo
Measure: Maintenance Phase Secondary End Point Percentage of subjects with hypokalaemia in subjects receiving either SZC or Placebo Time: 28 DaysDescription: Change from baseline in S-Aldo to end of the MP
Measure: Maintenance Phase Secondary End point. Change from baseline in S-Aldo to end of the MP Time: 28 DaysDescription: Proportion of participants per response category in Study Medication Palatability Assessment questionnaires (self-reported or observer assessment)
Measure: Maintenance Phase Secondary Endpoint. Proportion of patients per response category in Study Medication Palatability Assessment questionnaires. Time: 28 DaysDescription: Number and percentage of days of normokalaemia
Measure: Maintenance Phase Secondary End poinPercentage of days of normokalaemia. Time: 28 DaysDescription: Proportion of participants in whom normokalaemia can be maintained over the LTMP.
Measure: Long Term Maintenance Phase secondary endpointsProportion of participants in whom normokalaemia can be maintained over the LTMP. Time: 22 WeeksDescription: Proportion of participants who needed dose escalation/de-escalaion to higher dose levels during the LTMP
Measure: Long Term Maintenance Phase Secondary End Proportion of participants who needed dose escalation/de-esclation to higher dose levels during the LTMP. Time: 22 weeksDescription: Proportion of participants who needed dose de-escalation to lower dose levels during the LTMP
Measure: Long Term Maintenance Phase Secondary End PointProportion of participants who needed dose de-escalation to lower dose levels during the LTMP Time: 22 WeeksDescription: The percentage of subjects with hypokalaemia during the LTMP.
Measure: Long Term Maintenance Phase Secondary End Point Percentage of participants with hypokalaemia during LTMP Time: 22 WeeksDescription: Proportion of participants per response category in Study Medication Palatability Assessment questionnaires (self reported or observer assessment)
Measure: Long Term Maintenance Phase Secondary End PoinProportion of participants per response category in Study Medication Palatability Assessment. Time: 22 weeksDescription: Time to first day achievement of normokalaemia
Measure: Correction Phase Secondary enpoints Time to first day achievement of normokalaemia Time: From date of first dose in the Correction Phase to date of first date of normokalaemia, or date of censoring as applicable, assessed up to 72 hoursDescription: Absolute change from baseline in serum K levels at all intervals of follow-up after dosing has been initiated
Measure: Correction Phase Secondary Endpoint Absolute change from baseline in serum K levels at all intervals of follow-up Time: At baseline and at 24, 48 and 72 hoursDescription: Time to decrease of 0.5 mmol/L in serum K level
Measure: Correction Phase Secondary End Point Time to decrease of 0.5 mmol/L in serum K level Time: From date of first dose in the CP to date of first date of decrease of ≥0.5 mmol/L, or date of censoring as applicable, assessed up to 72 hours"Description: Proportion of patients per response category in Study Medication Palatability Assessment questionnaires (self reported or observer assessment)
Measure: Correction Phase Secondary EndpointProportion of patients per response category in Study Medication Palatability Assessment questionnaires. Time: At baseline and 48 hoursDescription: Change from Baseline to Visit 7 For Sodium (Plasma Electrolyte)
Measure: Maintenance Phase Secondary Endpoint Change from Baseline in Sodium (plasma electrolytes.) Time: 28 DaysDescription: Change from Baseline to Visit 7 For Potassium (Plasma Electrolyte)
Measure: Maintenance Phase Secondary Endpoint Change from Baseline in Potassium (plasma electrolytes.) Time: 28 DaysDescription: Change from Baseline to Visit 7 For Calcium (Plasma Electrolyte)
Measure: Maintenance Phase Secondary Endpoint Change from Baseline in Calcium ( plasma electrolytes.) Time: 28 DaysDescription: Change from Baseline to Visit 7 For Phosphrous (Plasma Electrolyte)
Measure: Maintenance Phase Secondary Endpoint Change from Baseline in Phosphrous ( plasma electrolytes.) Time: 28 DaysDescription: Change from Baseline to Visit 7 For Megnesium (Plasma Electrolyte)
Measure: Maintenance Phase Secondary Endpoint Change from Baseline in Megnesium ( plasma electrolytes.) Time: 28 DaysDescription: Percentage change from base in serum K levels at all intervals of follow up after dosing has been initiated.
Measure: Correction Phase Secondary Endpoint Percent change from baseline in serum K levels at all intervals of follow up Time: At Baseline and at 24, 48 and 72 HoursDescription: Percent change from baseline in serum K levels post dose during the MP and at any time point thereafter in each treatment group
Measure: percent change from baseline in serum K levels post dose during the MP and at any time point thereafter in each treatment group Time: 28 DaysDescription: The percentage of subjects with hyperkalaemia in participants receiving either SZC or placebo
Measure: The percentage of subjects with hyperkalaemia in participants receiving either SZC or placebo. Time: 28 DaysDescription: Change from Baseline to Visit 7 For Bicarbonate (plasma electrolytes)
Measure: Maintenance phase secondary end point change from baseline in Bicarbonate (plasma electrolytes) Time: 28 daysDescription: Change from Baseline to Visit 7 For Spot Urine PH.
Measure: Maintenance Phase Secondary Endpoint Change from Baseline in Spot Urine PH Time: 28 DaysDescription: Percentage of days of normokalaemia.
Measure: Maintenance Phase Secondary End Point percentage of days of normokalaemia Time: 28 DaysDescription: Proportion of patients per response category in Study Medication Palatability Assessment questionnaires (self reported or observer assessment)
Measure: Long Term Maintenance Phase Secondary End PoinProportion of patients per response category in Study Medication Palatability Assessment. Time: 22 weeksDescription: The percentage of participants with hyperkalaemia during the LTMP.
Measure: Long Term Maintenance Phase Secondary End Point Percentage of participants with hyperkalaemia during LTMP. Time: 22 WeeksDescription: Change from Baseline to Visit 7 For Spot urine Sodium.
Measure: Maintenance Phase Secondary Endpoint Change from Baseline in Spot Urine Sodium Time: 28 DaysDescription: Change from Baseline to Visit 7 For Spot urine Potassium.
Measure: Maintenance Phase Secondary Endpoint Change from Baseline in Spot Urine Potassium Time: 28 DaysDescription: Change from Baseline to Visit 7 For Spot urine Bicarbonate.
Measure: Maintenance Phase Secondary Endpoint Change from Baseline in Spot Urine Bicarbonate Time: 28 DaysAlphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
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.
Drug Reports MeSH Reports HPO Reports