Long-Term Treatment and Follow up of Subjects Completing 24 Months of Treatment With Tesevatinib on Study KD019-101

Phase 2

Terminated

• Conditions: Autosomal Dominant Polycystic Kidney Disease (ADPKD)
• Interventions: Drug: tesevatinib

• Registration Number: NCT02616055
• Lead Sponsor: Kadmon Corporation, LLC

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-11-24
• Study First Submitted QC: 2015-11-24
• Study First Posted: 2015-11-26
• Study Start: 2015-12-25
• Primary Completion: 2016-12-21
• Study Completion: 2016-12-21
• Disposition First Submitted: 2018-03-06
• Disposition First Submitted QC: 2018-03-08
• Disposition First Posted: 2018-03-09
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-23
• Last Update Posted: 2022-05-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 15

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
100mg Daily	tesevatinib	Two 50mg tesevatinib tablets per day
150mg M/Th	tesevatinib	Three 50mg tesevatinib tablets every Monday and Thursday.
150mg MWF	tesevatinib	Three 50mg tesevatinib tablets every Monday, Wednesday and Friday.
50mg Daily	tesevatinib	One 50mg tesevatinib tablet per day

Primary Outcome Measures

Name	Time	Method
Monitor Longitudinal Changes in Estimated Glomerular Filtration Rate	37 Months	Monitor longitudinal changes in estimated glomerular filtration rate (eGFR) in subjects with ADPKD when treated with tesevatinib.

Secondary Outcome Measures

Name	Time	Method
Monitor Longitudinal Changes in Total Kidney Volume	37 Months	Monitor longitudinal changes from baseline in total kidney volume (TKV) in subjects with ADPKD when treated with tesevatinib.
Number of Subjects Experiencing Adverse Events as a Measure of Safety and Tolerability	37 Months	To evaluate the long term safety and tolerability of tesevatinib in subjects with ADPKD when treated with tesevatinib.

Trial Locations

Locations (6)

Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States

University of Virginia - Nephrology Clinical Research Center; 🇺🇸 Charlottesville, Virginia, United States

UCLA Medical Center; 🇺🇸 Los Angeles, California, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States