A Double-blind Randomized Parallel Group Study of the Efficacy and Safety of Tesevatinib in Subjects with Autosomal Dominant Polycystic Kidney Disease
Protocol No: KD019-211
Sponsor: Kadmon Corporation, LLC
Investigator: Kianoosh Kaveh, DO
You have been diagnosed with a medical condition called autosomal dominant polycystic kidney disease (ADPKD). As a result, you are being asked to participate in a clinical trial or research study that is sponsored by Kadmon Corporation, LLC (the “Sponsor”) and is being conducted in collaboration with the research center where you are receiving medical care.
Purpose of this Study
The purpose of this study is to find out if the experimental study drug, tesevatinib, works as a treatment for ADPKD and if it is safe. Tesevatinib is made by the Sponsor, who provides funding to this facility for the conduct of this study.
Tesevatinib is an experimental drug that stops a protein (enzyme) and may slow down or stop uncontrolled growth of kidney cells as a treatment for ADPKD. To date, over 350 people have been enrolled in studies using tesevatinib. In the first studies, subjects received doses up to 350 mg per day. In some studies, subjects received tesevatinib continuously and in others they received tesevatinib for 5 days in a row followed by a 9-day break.
Compensation You will be paid $150 each for Screening visit, Month 12, Month 18 and Month 24 visits. You will be paid $50 each for Day 1, Day 14, Day 28, Month 2, Month 4, Month 5, Month 7, Month 8, Month 10, Month 11, Month 14, Month 16, Month 20, Month 22 and EOS visits. You will be paid $100 each for Month 3, Month 6 and Month 9 visits. You will receive a study stipend every quarter for study visits completed per protocol during that time.