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RECRUITING
NCT07219121
PHASE4

Sparsentan in Posttransplant Immunoglobulin A Nephropathy or Focal Segmental Glomerulosclerosis

Sponsor: Travere Therapeutics, Inc.

View on ClinicalTrials.gov

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

Interventions

DRUG

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