Sparsentan in Posttransplant Immunoglobulin A Nephropathy or Focal Segmental Glomerulosclerosis

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Travere Therapeutics, Inc.
Study ID
NCT07219121
Phase
PHASE4
Status
Recruiting
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Conditions

  • Focal Segmental Glomerulosclerosis
  • Immunoglobulin A (IgA) Nephropathy
  • Kidney Transplant
  • Proteinuria

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sparsentan — DRUG
    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.

Study Details

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.

Key Dates

Start date
Oct 7, 2025
Status verified
Feb 2026
Primary completion
Mar 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Drug: Sparsentan
    A non-immunosuppressive single molecule with dual antagonism of ETAR and AT1R, has shown potent anti-proteinuric effect in patients with native kidney disease, including IgAN and FSGS.

Primary Outcome Measure

Urinary protein/creatinine ratio (UPCR) [ Time Frame: 36 weeks ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294-
Cornell Medical CenterNew YorkNew York10065-
University of North Carolina Chapel HillMorrisvilleNorth Carolina27560-
Ohio State UniversityColumbusOhio43210-
University of Pittsburgh Medical CenterPittsburghPennsylvania15213-
Dallas Nephrology AssociatesDallasTexas75204-
University of TexasGalvestonTexas27599-
University of WashingtonSeattleWashington98195-
University of WisconsinMadisonWisconsin53705-

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham· Birmingham, ALCornell Medical Center· New York, NYUniversity of North Carolina Chapel Hill· Morrisville, NCOhio State University· Columbus, OHUniversity of Pittsburgh Medical Center· Pittsburgh, PADallas Nephrology Associates· Dallas, TX

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