Sparsentan in Posttransplant Immunoglobulin A Nephropathy or Focal Segmental Glomerulosclerosis

NCT07219121 | Recruiting Phase 4 FDA Drug

• 1 other identifier: TVTX-RE021-426
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 9

Brief 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.

Conditions

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

Keywords

IgAN; FSGS; kidney transplant; proteinuria

Outcome Measures

Primary Outcomes (1)

• Urinary protein/creatinine ratio (UPCR)

  Change from baseline (Day 1) in urinary protein/creatinine ratio (UPCR) to Week 36.

  36 weeks

Secondary Outcomes (6)

• Change from baseline in UPCR

  36 weeks

• Urinary albumin/creatinine ratio (UACR)

  36 weeks

• Change from baseline in eGFR (estimated glomerular filtration rate)

  36 weeks

• Change from baseline in blood pressure (BP)

  36 weeks

• Achievement of UPCR <0.3 g/g

  36 weeks

Study Arms (1)

Drug: Sparsentan

EXPERIMENTAL

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.

Drug: Sparsentan

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.

Drug: Sparsentan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in the protocol.
• Male and female aged ≥18 years
• Participants with a kidney transplant with biopsy-proven IgAN or FSGS histological pattern in the graft.
• A period of ≥12 months since kidney transplantation.
• UPCR ≥0.5 g/g and eGFR (CKD-EPI creatinine-based formula ≥30 mL/min/1.73 m2.
• Participants who can become pregnant, must agree to the use of 1 highly reliable method of contraception from 7 days prior to the first dose of study intervention until 30 days after the last dose of study intervention.
• Systolic BP ≤160 mmHg and ≥100 mmHg, and diastolic BP ≤100 mmHg and ≥60 mmHg at screening.
• For participants on an ACEI and/or ARB, and/or sodium glucose cotransporter-2 (SGLT2) inhibitor, the dosing regimen(s) is stable for ≥6 weeks prior to screening.

You may not qualify if:

• Participant has multiorgan transplants (with the exception of pancreas and corneal transplants).
• Immunosuppressive therapy (IST) regimen for kidney transplant or other systemic chronic ISTs including enteric budesonide that is not stable for \>6 weeks prior to Day 1. Exceptions include routine changes in the dose of CNIs to meet target level.
• \<3 months after antirejection treatment and active rejection.
• Active bacterial, fungal or viral infection and/or active treatment of infection including BK virus (BKV), cytomegalovirus (CMV), human immunodeficiency virus (HIV), Hepatitis B and C \<3 months prior to and during the screening period.
• Current treatment for surgical complications.
• History of heart failure (New York Heart Association \[NYHA\] Class II-IV).
• Jaundice, hepatitis, or known hepatobiliary disease.
• Malignancy within the past 2 years with the exception of adequately treated basal cell carcinoma or non-metastatic squamous cell carcinoma of the skin, with no evidence or recurrence.
• History of alcohol or illicit drug use disorder (as defined in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition).
• History of serious side effects or allergic response to any angiotensin II antagonist or ERA.
• Participant requires any of the prohibited concomitant medications.
• Treatment with sparsentan \<12 weeks prior to screening.
• Participant has participated in a study of another investigational product \<28 days prior to screening or plans to participate in such a study during the course of this study.
• Hematocrit \<27%, hemoglobin \<90 g/L (9 g/dL), or potassium \>5.5 mmol/L (5.5 mEq/L).
• The participant is pregnant, plans to become pregnant during the course of the study, or is breastfeeding.

Sponsors & Collaborators

• Travere Therapeutics, Inc.: lead

Study Sites (9)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

RECRUITING

Cornell Medical Center

New York, New York, 10065, United States

RECRUITING

University of North Carolina Chapel Hill

Morrisville, North Carolina, 27560, United States

RECRUITING

Ohio State University

Columbus, Ohio, 43210, United States

RECRUITING

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

Dallas Nephrology Associates

Dallas, Texas, 75204, United States

RECRUITING

University of Texas

Galveston, Texas, 27599, United States

RECRUITING

University of Washington

Seattle, Washington, 98195, United States

RECRUITING

University of Wisconsin

Madison, Wisconsin, 53705, United States

RECRUITING

MeSH Terms

Conditions

Proteinuria; Kidney Diseases; Glomerulosclerosis, Focal Segmental

Interventions

sparsentan

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glomerulonephritis; Nephritis

Study Officials

• Radko Komers, MD, PhD

  Travere Therapeutics

  STUDY DIRECTOR

Central Study Contacts

Travere Call Center

CONTACT

1-877-659-5518; medinfo@travere.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 46-week, open-label, multicenter, single-group Phase 4 study

Study Record Dates

• First Submitted: October 9, 2025
• First Posted: October 21, 2025
• Study Start: October 7, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Time Frame: Requests can be made following completion of the study and full publication of the study data in a peer reviewed journal for up to 36 months following its publication.

Locations

US (9)