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

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

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.

Study Overview

• Status: Terminated
• Conditions: Autosomal Dominant Polycystic Kidney Disease (ADPKD)
• Intervention / Treatment: Drug: tesevatinib

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90025
      • UCLA Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia - Nephrology Clinical Research Center
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College Of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 62 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 50mg Daily; One 50mg tesevatinib tablet per day	Drug: tesevatinib; Other Names: KD019; XL647
Experimental: 100mg Daily; Two 50mg tesevatinib tablets per day	Drug: tesevatinib; Other Names: KD019; XL647
Experimental: 150mg M/Th; Three 50mg tesevatinib tablets every Monday and Thursday.	Drug: tesevatinib; Other Names: KD019; XL647
Experimental: 150mg MWF; Three 50mg tesevatinib tablets every Monday, Wednesday and Friday.	Drug: tesevatinib; Other Names: KD019; XL647

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Kadmon Corporation, LLC

Study record dates

Study Major Dates

• Study Start: December 25, 2015
• Primary Completion (Actual): December 21, 2016
• Study Completion (Actual): December 21, 2016

Study Registration Dates

• First Submitted: November 24, 2015
• First Submitted That Met QC Criteria: November 24, 2015
• First Posted (Estimate): November 26, 2015

Study Record Updates

• Last Update Posted (Actual): May 25, 2022
• Last Update Submitted That Met QC Criteria: May 23, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Congenital Abnormalities; Genetic Diseases, Inborn; Abnormalities, Multiple; Kidney Diseases, Cystic; Ciliopathies; Kidney Diseases; Polycystic Kidney Diseases; Polycystic Kidney, Autosomal Dominant; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; XL647
• Other Study ID Numbers: KD019-207