Trial · NCT04064346
Outcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Annualized Change in Estimated Glomerular Filtration Rate (eGFR) - Part 1 | Baseline to the end of Follow-up Period I (up to 71 weeks) | Efficacy data were not analyzed as only 5 participants were randomized, and all 5 participants were prematurely terminated from the study drug by the sponsor less than 1 month following randomization. One month after randomization was the first scheduled post-randomization visit during which efficacy parameters would have been collected. | ||
| PRIMARY | Annualized Change in Estimated Glomerular Filtration Rate (eGFR) - Part 2 | Baseline to the end of Follow-up Period II (up to 64 weeks) | Efficacy data were not analyzed as only 5 participants were randomized, and all 5 participants were prematurely terminated from the study drug by the sponsor less than 1 month following randomization. One month after randomization was the first scheduled post-randomization visit during which efficacy parameters would have been collected. The study terminated prior to any participants entering Part 2 of study. | ||
| 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) | All participants who entered the Double-blind Randomized Treatment Period. | Participants | COUNT_OF_PARTICIPANTS |
| 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) | The study terminated prior to any participants entering Part 2 of study. | ||
| 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 | Efficacy data were not analyzed as only 5 participants were randomized, and all 5 participants were prematurely terminated from the study drug by the sponsor less than 1 month following randomization. One month after randomization was the first scheduled post-randomization visit during which efficacy parameters would have been collected. | ||
| 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 | Efficacy data were not analyzed as only 5 participants were randomized, and all 5 participants were prematurely terminated from the study drug by the sponsor less than 1 month following randomization. One month after randomization was the first scheduled post-randomization visit during which efficacy parameters would have been collected. The study terminated prior to any participants entering Part 2 of study. | ||
| SECONDARY | Height-adjusted Total Kidney Volume (htTKV) - Part 1 | Baseline to the end of Follow-up Period I (up to 71 weeks) | Efficacy data were not analyzed as only 5 participants were randomized, and all 5 participants were prematurely terminated from the study drug by the sponsor less than 1 month following randomization. One month after randomization was the first scheduled post-randomization visit during which efficacy parameters would have been collected. | ||
| SECONDARY | Height-adjusted Total Kidney Volume (htTKV) - Part 2 | Baseline to the end of Follow-up Period II (up to 60 weeks) | Efficacy data were not analyzed as only 5 participants were randomized, and all 5 participants were prematurely terminated from the study drug by the sponsor less than 1 month following randomization. One month after randomization was the first scheduled post-randomization visit during which efficacy parameters would have been collected. The study terminated prior to any participants entering Part 2 of study. | ||
| SECONDARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the Lixivaptan Titration Period in Part 1 | Up to 6 weeks | All participants entering the Lixivaptan Titration Period. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With TEAEs After Randomization in Part 1 | From Randomization to study completion (up to 102 days) | All participants who were randomized. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With TEAEs in Part 2 | Up to 60 weeks | All participants were prematurely terminated from the study drug by the sponsor less than 1 month following randomization; none proceeded to Part 2 of the study. | ||
| SECONDARY | Number of Participants With Potentially Clinically Important Clinical Laboratory Findings During the Lixivaptan Titration Period in Part 1 | Up to 6 weeks | All participants entering the Lixivaptan Titration Period. | Participants | COUNT_OF_PARTICIPANTS |
| 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) | All participants who were randomized. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Potentially Clinically Important Clinical Laboratory Findings in Part 2 | Up to 60 weeks | All participants were prematurely terminated from the study drug by the sponsor less than 1 month following randomization; none proceeded to Part 2 of the study. | ||
| SECONDARY | Number of Participants With Potentially Clinically Important Vital Signs Findings During the Lixivaptan Titration Period in Part 1 | Up to 6 weeks | All participants entering the Lixivaptan Titration Period. | Participants | COUNT_OF_PARTICIPANTS |
| 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) | All participants who were randomized. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Potentially Clinically Important Vital Signs Findings in Part 2 | Up to 60 weeks | All participants were prematurely terminated from the study drug by the sponsor less than 1 month following randomization; none proceeded to Part 2 of the study. | ||
| 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 | All participants entering the Lixivaptan Titration Period. | Participants | COUNT_OF_PARTICIPANTS |
| 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) | All participants who were randomized. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Potentially Clinically Significant 12-lead ECG Findings in Part 2 | Up to 60 weeks | All participants were prematurely terminated from the study drug by the sponsor less than 1 month following randomization; none proceeded to Part 2 of the study. |
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.
For software
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GET https://conductscience.org/api/trials/v1/NCT04064346/outcomes