Overview

This trial is active, not recruiting.

Condition autosomal dominant polycystic kidney disease (adpkd)
Treatment tesevatinib
Phase phase 2
Sponsor Kadmon Corporation, LLC
Start date December 2015
End date November 2018
Trial size 50 participants
Trial identifier NCT02616055, KD019-207

Summary

Subjects who received tesevatinib in Study KD019-101 and completed 24 months of treatment will continue on the dose of tesevatinib they were receiving at 24 months on the KD019-101 study.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
One 50mg tesevatinib tablet per day
tesevatinib KD019, XL647
(Experimental)
Two 50mg tesevatinib tablets per day
tesevatinib KD019, XL647
(Experimental)
Three 50mg tesevatinib tablets every Monday and Thursday.
tesevatinib KD019, XL647
(Experimental)
Three 50mg tesevatinib tablets every Monday, Wednesday and Friday.
tesevatinib KD019, XL647

Primary Outcomes

Measure
Monitor Longitudinal Changes in Estimated Glomerular Filtration Rate
time frame: 37 Months

Secondary Outcomes

Measure
Monitor Longitudinal Changes in Total Kidney Volume
time frame: 37 Months
Number of Subjects Experiencing Adverse Events as a Measure of Safety and Tolerability
time frame: 37 Months

Eligibility Criteria

Male or female participants from 18 years up to 55 years old.

Inclusion Criteria: - The subject must have received 24 months of treatment with tesevatinib on study KD019-101. (Twenty-four months of study drug treatment includes days without treatment that were allowed by the KD019-101 protocol.) - Sexually active subject (male and female) has agreed to use two forms of accepted methods of contraception during the course of the study and for 3 months after the last dose of study drug. Effective birth control includes (a) IUD plus one barrier method; (b) on stable doses of hormonal contraception for at least 3 months (eg, oral, injectable, implant, transdermal) plus one barrier method; or (c) 2 barrier methods. Effective barrier methods are male or female condoms, diaphragms, and spermicides (creams or gels that contain a chemical to kill sperm). - Female subjects of childbearing potential have a negative pregnancy test at screening. Females of childbearing potential are defined as sexually mature women without prior hysterectomy or who have had any evidence of menses in the past 12 months. However, women who have been amenorrheic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, anti-estrogens, or ovarian suppression.

Additional Information

Official title Long-Term Treatment and Follow up of Subjects Completing 24 Months of Treatment With Tesevatinib on Study KD019-101 in Subjects With Autosomal Dominant Polycystic Kidney Disease
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Kadmon Corporation, LLC.