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Sparsentan in Posttransplant Immunoglobulin A Nephropathy or Focal Segmental Glomerulosclerosis
Sponsor: Travere Therapeutics, Inc.
Summary
To evaluate the safety and efficacy of sparsentan tablets for the treatment of patients with proteinuria after kidney transplantation with once-daily dosing for 36 weeks.
Official title: A Multicenter, Open-label Single Arm Study to Evaluate the Safety and Efficacy of Sparsentan in Posttransplant Immunoglobulin A Nephropathy (IgAN) or Focal Segmental Glomerulosclerosis (FSGS) (SPARX)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2025-10-07
Completion Date
2027-05
Last Updated
2026-02-27
Healthy Volunteers
No
Conditions
Interventions
Sparsentan
For participants with a kidney transplant with IgAN: Day 1 through Week 2 visit, participants will take 200 mg once daily (QD) prior to the morning meal. At the Week 2 visit, participants will titrate up to 400 mg QD and take this dose through Week 36, if tolerated and determined to be safe by the Investigator. For participants with a kidney transplant with FSGS, or a biopsy finding of both IgAN and glomeruli with FSGS patterns: Day 1 through Week 2 visit, participants will take 400 mg QD prior to the morning meal. At the Week 2 visit, participants will titrate up to 800 mg QD and take this dose through Week 36, if tolerated and determined to be safe by the Investigator.
Locations (9)
University of Alabama at Birmingham
Birmingham, Alabama, United States
Cornell Medical Center
New York, New York, United States
University of North Carolina Chapel Hill
Morrisville, North Carolina, United States
Ohio State University
Columbus, Ohio, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Dallas Nephrology Associates
Dallas, Texas, United States
University of Texas
Galveston, Texas, United States
University of Washington
Seattle, Washington, United States
University of Wisconsin
Madison, Wisconsin, United States