RecruitingPhase 4NCT07219121

Sparsentan in Posttransplant Immunoglobulin A Nephropathy or Focal Segmental Glomerulosclerosis

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)

Sponsor

Travere Therapeutics, Inc.

Enrollment

20 participants

Start Date

Oct 7, 2025

Study Type

INTERVENTIONAL

Conditions

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

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria8

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.

Exclusion Criteria17

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.
The participant, in the opinion of the Investigator, is unable to adhere to the requirements of the study, including the ability to swallow the study IMP whole.
The participant, in the opinion of the Investigator, has a medical condition or abnormal clinically significant laboratory screening value not listed above that may interfere with the evaluation of sparsentan safety or activity.

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Interventions

DRUGSparsentan

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.