Trial · NCT04064346
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Annualized Change in Estimated Glomerular Filtration Rate (eGFR) - Part 1 | Baseline to the end of Follow-up Period I (up to 71 weeks) | The annualized change in eGFR will be calculated from the Chronic Kidney Disease Epidemiology Collaboration eGFR creatinine equation refit without the race variable (CKD-EPIcr\_R) equation for serum creatinine from baseline (mean of 3 eGFR determinations obtained during Screening and Placebo Run-in Periods \[Visits 1a/1b (if required), Visit 2, and Visit 3\]) to final assessment (mean of 3 eGFR determinations obtained during Follow-up Period I or, for participants who discontinue treatment prior to Visit 22, during the Follow-up Period 8 to 28 days following study drug treatment discontinuation). |
| Primary | Annualized Change in Estimated Glomerular Filtration Rate (eGFR) - Part 2 | Baseline to the end of Follow-up Period II (up to 64 weeks) | The annualized change in eGFR will be calculated from the CKD-EPIcr\_R equation for serum creatinine from baseline (mean of 3 eGFR determinations obtained during obtained during Follow-up Period I) to final assessment (mean of 3 eGFR determinations obtained during Follow-up Period II or, for participants who discontinue treatment prior to Visit 43, during the Follow-up Period 8 to 28 days following study drug treatment discontinuation). |
| Secondary | Number of Participants With Serum Alanine Aminotransferase (ALT) Levels >3 × the Upper Limit of Normal (ULN) - Part 1 | From the end of the Single-blind Lixivaptan Titration Period to the end of Follow-up Period I (maximum of 102 days) | Number of participants randomized to lixivaptan with serum ALT levels \>3 × the ULN compared to those randomized to placebo. The normal range of ALT was defined as 0-33 or 0-44 U/L, depending on the lab used. |
| Secondary | Number of Participants With Serum ALT Levels >3 × the ULN - Part 2 | Duration of the Lixivaptan Re-titration Period and the Maintenance Treatment Period (56 weeks) and Follow-up Period II (4 weeks) | Number of participants randomized to lixivaptan with serum ALT levels \>3 × ULN compared to those randomized to placebo. The normal range of ALT was defined as 0-33 or 0-44 U/L, depending on the lab used. |
| Secondary | eGFR Slope - Part 1 | Baseline to the end of Double-blind Randomized Treatment Period (up to 67 weeks), with changes from baseline calculated every 4 weeks during the Double-blind Randomized Treatment Period | Annualized rate of change (slope) in eGFR for serum creatinine, based on all eGFR determinations from baseline to all visits with on-treatment eGFR values during the Double-blind, Randomized Treatment Period. The baseline value will be calculated as the mean of 3 eGFR determinations obtained during Screening and Placebo Run-in Periods (Visits 1a/1b \[if required\], Visit 2, and Visit 3). |
| Secondary | eGFR Slope - Part 2 | Baseline to the end of the Maintenance Treatment Period (up to 60 weeks), with changes from baseline calculated every 4 weeks during the Maintenance Treatment Period | Annualized rate of change (slope) in eGFR for serum creatinine, based on all eGFR determinations from baseline to all visits with on-treatment eGFR values during the Maintenance Treatment Period. The baseline value will be calculated as the mean of 3 eGFR determinations obtained during obtained during Follow-up Period I. |
| Secondary | Height-adjusted Total Kidney Volume (htTKV) - Part 1 | Baseline to the end of Follow-up Period I (up to 71 weeks) | Annualized percent change in htTKV, determined by magnetic resonance imaging (MRI), from baseline (obtained at Screening \[Visit 1a\]) to the end of Follow-up Period I. |
| Secondary | Height-adjusted Total Kidney Volume (htTKV) - Part 2 | Baseline to the end of Follow-up Period II (up to 60 weeks) | Annualized percent change in htTKV, determined by MRI from baseline (obtained at Visit 25/Week 56) to the end of Follow-up Period II. |
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the Lixivaptan Titration Period in Part 1 | Up to 6 weeks | Number of participants with TEAEs during the Lixivaptan Titration Period. |
| Secondary | Number of Participants With TEAEs After Randomization in Part 1 | From Randomization to study completion (up to 102 days) | Number of participants with TEAEs by treatment group after Randomization (Double-blind Randomized Treatment Period and Follow-up Period I) |
| Secondary | Number of Participants With TEAEs in Part 2 | Up to 60 weeks | Number of participants with TEAEs by treatment cohort during Part 2 (Lixivaptan Re-titration Period, Maintenance Treatment Period, and Follow-up Period II). |
| Secondary | Number of Participants With Potentially Clinically Important Clinical Laboratory Findings During the Lixivaptan Titration Period in Part 1 | Up to 6 weeks | Number of participants with clinical laboratory findings (clinical chemistry, hematology and urinalysis) recorded during the Lixivaptan Titration Period and considered to be potentially clinically important. |
| Secondary | Number of Participants With Potentially Clinically Important Clinical Laboratory Findings After Randomization in Part 1 | From Randomization to last clinical laboratory evaluation (up to 102 days) | Number of participants with clinical laboratory findings (clinical chemistry, hematology and urinalysis) recorded after Randomization (Double-blind Randomized Treatment Period and Follow-up Period I) and considered to be potentially clinically important, by treatment group. |
| Secondary | Number of Participants With Potentially Clinically Important Clinical Laboratory Findings in Part 2 | Up to 60 weeks | Number of participants with clinical laboratory findings (clinical chemistry, hematology and urinalysis) recorded during Part 2 (Lixivaptan Re-titration Period, Maintenance Treatment Period, and Follow-up Period II) and considered to be potentially clinically important, by treatment cohort. |
| Secondary | Number of Participants With Potentially Clinically Important Vital Signs Findings During the Lixivaptan Titration Period in Part 1 | Up to 6 weeks | Number of participants with vital signs findings (heart rate, diastolic and systolic blood pressure, weight) recorded during the Lixivaptan Titration Period and considered to be potentially clinically important. |
| Secondary | Number of Participants With Potentially Clinically Important Vital Signs Findings After Randomization in Part 1 | From Randomization to last measurement of vital signs (up to 102 days) | Number of participants with vital signs findings (heart rate, diastolic and systolic blood pressure, weight) recorded after Randomization (Double-blind Randomized Treatment Period and Follow-up Period I) and considered to be potentially clinically important, by treatment group. |
| Secondary | Number of Participants With Potentially Clinically Important Vital Signs Findings in Part 2 | Up to 60 weeks | Number of participants with vital signs findings (heart rate, diastolic and systolic blood pressure, weight) recorded during Part 2 (Lixivaptan Re-titration Period, Maintenance Treatment Period, and Follow-up Period II) and considered to be potentially clinically important, by treatment cohort. |
| Secondary | Number of Participants With Potentially Clinically Significant 12-lead Electrocardiogram (ECG) Findings During the Lixivaptan Titration Period in Part 1 | Up to 6 weeks | Number of participants with ECG findings recorded during the Lixivaptan Titration Period and considered to be potentially clinically important (defined as a QT interval corrected for heart rate according to Fridericia's formula \[QTcF\] ≥ 450 msec). |
| Secondary | Number of Participants With Potentially Clinically Significant 12-lead ECG Findings After Randomization in Part 1 | From Randomization to last ECG (up to 102 days) | Number of participants with ECG findings recorded after Randomization (Double-blind Randomized Treatment Period and Follow-up Period I) and considered to be potentially clinically important (defined as a QTcF ≥ 450 msec), by treatment group. |
| Secondary | Number of Participants With Potentially Clinically Significant 12-lead ECG Findings in Part 2 | Up to 60 weeks | Number of participants with ECG findings recorded during Part 2 (Lixivaptan Re-titration Period, Maintenance Treatment Period, and Follow-up Period II) and considered to be potentially clinically important (defined as a QTcF ≥ 450 msec), by treatment cohort. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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