DUET: Efficacy and Safety of RE-021, A Dual Endothelin receptor and Angiotensin Receptor Blocker, in Patients with Focal Segmental Glomerulosclerosis (FSGS): A Randomized, Double-Blind, Active-Control, Dose-Escalation Study
Principal Investigator: Patrick Nachman, MD
Sponsor: Retrophin, Inc
Age Range: 8-75
Status: Ongoing; not enrolling
Purpose: The purpose of the DUET study is to evaluate the safety and effectiveness of an investigational drug in patients with focal segmental glomerulosclerosis (FSGS). The goal is to learn whether the investigational drug, called RE-021, may change the amount of protein in the urine and decrease proteinuria. RE-021 will be compared to the drug irbesartan, which is approved to treat high blood pressure, kidney disease caused by diabetes, and proteinuria.
Study Procedures: After the screening period (a period of observation without study drug), there is an 8-week period during which participants will receive either RE-021 or irbesartan. Following the 8-week treatment period, participants may be able to continue taking RE-021 for 136 weeks. The study drugs are taken orally.
Participation: Participation in the study may last approximately 3 years and include up to 19 visits to UNC.
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