At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 31 enrolled
Drug / intervention
Lixivaptandrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2, Open-Label, Multi-Center Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of Lixivaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease
In Brief
A Phase 2 clinical trial evaluating Lixivaptan for Autosomal Dominant Polycystic Kidney Disease. Completed, enrolled 31 participants across 13 sites.
Detailed Summary
This is a Phase 2, open-label, parallel-group, multiple dose study designed to evaluate the pharmacokinetics, pharmacodynamics, safety and tolerability of multiple doses of lixivaptan in Autosomal Dominant Polycystic Kidney Disease subjects with chronic kidney disease (CKD) in stages CKD1, CKD2 or CKD3.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20192020202120222023202420252026
First PostedApr 2018
Enrollment StartSep 2018
Primary CompletionDec 2019
Study CompletionFeb 2020
TodayJul 2026
First PostedApr 4, 2018
Enrollment StartSep 14, 2018
Primary CompletionDec 2, 2019
Study CompletionFeb 11, 2020
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 8.2 years ago
Interventions
Lixivaptandrug
Oral vasopressin V2 receptor antagonist