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Study of the Efficacy and Safety of Tesevatinib in Subjects With ADPKD

NCT03203642 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2023-02-06

Study results available
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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).

Conditions

  • Autosomal Dominant Polycystic Kidney
  • ADPKD

Interventions

DRUG

Tesevatinib

Pharmaceutical form: Tablet; Route of administration: orally

DRUG

Placebo

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

Sponsors & Collaborators

  • Kadmon, a Sanofi Company

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-12
Primary Completion
2022-01-25
Completion
2022-01-25
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03203642 on ClinicalTrials.gov