CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 80 enrolled
Drug / intervention
Tesevatinib +1 moredrug
Likely dose
Not stated in record
Key inclusion· 4
  • ✓ADPKD diagnosis confirmed by Ravine's criteria.
  • ✓Renal cysts at least 1 cm in size.
  • ✓eGFR 25-90 mL/min/1.73 m² by MDRD-4 formula.
  • ✓Height-adjusted total kidney volume (htTKV) ≥500 mL (age 18-35), ≥750 mL (age 36-49), or ≥900 mL (age 50-60).
Key exclusion· 16
  • ✕Prior nephrectomy or kidney transplant.
  • ✕Tuberous sclerosis or Von Hippel-Lindau disease.
  • ✕Acquired cystic kidney disease or congenital absence of one kidney.
  • ✕Uncontrolled hypertension.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03203642
NCT03203642Phase 2Completed
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A Double-blind Randomized Parallel Group Study of the Efficacy and Safety of Tesevatinib in Subjects With Autosomal Dominant Polycystic Kidney Disease

Kadmon, a Sanofi Company·interventional·Posted Jun 29, 2017·Updated Feb 6, 2023

In Brief

A Phase 2 clinical trial evaluating Tesevatinib and Placebo for Autosomal Dominant Polycystic Kidney and ADPKD. Completed, enrolled 80 participants across 19 sites.

Detailed Summary

The goal of the study was to compare and evaluate safety and efficacy of tesevatinib 50 milligrams (mg) versus placebo in participants with autosomal dominant polycystic kidney disease (ADPKD).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAutosomal Dominant Polycystic Kidney, ADPKD
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedJun 29, 2017
Enrollment StartOct 12, 2017
Primary CompletionJan 25, 2022
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 9.0 years ago

Interventions

Tesevatinibdrug

Pharmaceutical form: Tablet; Route of administration: orally

Placebodrug

Pharmaceutical form: Tablet (identical to tesevatinib); Route of administration: orally