At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 69 enrolled
Drug / intervention
Tesevatinibdrug
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 1b/2a, Safety, Pharmacokinetic and Dose-Escalation Study of KD019 (Tesevatinib) in Subjects With Autosomal Dominant Polycystic Kidney Disease (ADPKD)
In Brief
A Phase 2 clinical trial evaluating Tesevatinib for Polycystic Kidney, Autosomal Dominant. Completed, enrolled 69 participants across 11 sites.
Detailed Summary
The primary objective of this study Phase 1b was to determine the safety, plasma pharmacokinetics, and maximum tolerated dose (MTD) of tesevatinib when administered to participants with autosomal dominant polycystic kidney disease (ADPKD). The primary objective of this study Phase 2a was to evaluate the annualized change in glomerular filtration rate (GFR) in participants with ADPKD when treated with tesevatinib.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPolycystic Kidney, Autosomal Dominant
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 2012
Enrollment StartOct 2012
Primary CompletionFeb 2019
TodayJul 2026
First PostedMar 21, 2012
Enrollment StartOct 11, 2012
Primary CompletionFeb 8, 2019
TodayJul 2, 2026
Enrollment to primary: 6.3 yearsPosted 14.3 years ago
Interventions
Tesevatinibdrug
Pharmaceutical form: Tablets Route of administration: Oral