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

Autosomal Dominant Polycystic Kidney Disease (ADPKD) Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02616055
• Other study ID #: KD019-207
• Status: Terminated
• Phase: Phase 2
• Start date: December 25, 2015
• Est. completion date: December 21, 2016

Study information

• Verified date: May 2022
• Source: Kadmon Corporation, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: December 21, 2016
• Est. primary completion date: December 21, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 62 Years

Eligibility

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.

Related Conditions & MeSH terms

• Autosomal Dominant Polycystic Kidney Disease (ADPKD)
• Kidney Diseases
• Polycystic Kidney Diseases
• Polycystic Kidney, Autosomal Dominant

Intervention

Drug:
• tesevatinib

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	University of Virginia - Nephrology Clinical Research Center	Charlottesville	Virginia
United States	Cleveland Clinic	Cleveland	Ohio
United States	UCLA Medical Center	Los Angeles	California
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Kadmon Corporation, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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