A Study to Investigate Safety and Effect of Sparsentan in Combination With SGLT2 Inhibition in Participants With IgAN

NCT05856760 | Completed Phase 2 Results FDA Drug

• 1 other identifier: TVTX-RE021-204
• Study Type: interventional
• Target: 48
• Locations: 2 countries
• Sites: 30

Brief Summary

This was a 28-week, open-label, multicenter, single-group Phase 2 exploratory study to determine the safety and effect of sparsentan in participants with IgAN who are at risk of disease progression to kidney failure despite being on both stable RAASi and SGLT2 inhibitor treatment for at least 12 weeks prior to study entry

Conditions

Immunoglobulin A Nephropathy

Keywords

IgAN

Outcome Measures

Primary Outcomes (1)

• Change in Urine Albumin-creatinine Ratio (UA/C) at Week 24

  The change from baseline in UA/C at Week 24 based on first morning void (FMV) samples

  Week 24

Secondary Outcomes (7)

• UA/C <0.2 g/g at Week 24

  Week 24

• 30% Reduction From Baseline in UA/C at Week 24

  Week 24

• 50% Reduction From Baseline in UA/C at Week 24

  Week 24

• Change in Urine Protein-to-creatinine Ratio (UP/C) at Week 24

  Week 24

• Estimated Glomerular Filtration Rate (eGFR)

  Week 24

Study Arms (1)

sparsentan

EXPERIMENTAL

Sparsentan will be administered daily as a 200-mg oral tablet. The goal is to titrate from the initial dose of 200 mg (Day 1) to the target dose of 400 mg at Week 2.

Drug: Sparsentan

Interventions

Sparsentan DRUG

Target dose of 400 mg daily

Also known as: Filspari, RE-021

sparsentan

Eligibility Criteria

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

You may qualify if:

• Aged ≥18 years at the time of signing the informed consent.
• Biopsy-proven IgAN. The biopsy may have been performed at any time in the past.
• UA/C ≥0.3 g/g at screening
• An eGFR value of ≥25 mL/min/1.73m\^2 at screening.
• On a stable dose of an SGLT2 inhibitor for at least 12 weeks prior to screening.
• On a stable dose of ACEI and/or ARB therapy for at least 12 weeks prior to screening that is:
• The participant's maximum tolerated dose (MTD), and
• at least one half of the maximum labeled dose (MLD)
• Systolic BP must be ≤160 mmHg, and diastolic BP must be ≤110 mmHg at screening.
• For participants receiving chronic low dose systemic corticosteroids (defined as ≤10 mg/day prednisone or equivalent), or an enteric formulation of budesonide and/or a mineralocorticoid receptor antagonist (MRA), the dosage must be stable for ≥12 weeks prior to screening.

You may not qualify if:

• IgAN secondary to another condition or immunoglobulin A (IgA) vasculitis.
• Undergone any organ transplant, with the exception of corneal transplants.
• Documented history of heart failure.
• Taking high dose (defined as \>10 mg/day prednisone) or other any systemic immunosuppressive medications within 12 weeks of prior to screening.
• Has clinically significant cerebrovascular disease (transient ischemic attack or stroke) and/or coronary artery disease (hospitalization for myocardial infarction unstable angina, new onset of angina with positive functional tests, coronary angiogram revealing stenosis, or a coronary revascularization procedure) within 3 months prior to screening.
• Has jaundice, hepatitis, or known hepatobiliary disease (excluding asymptomatic cholelithiasis), or ALT and/or AST \>2 times the ULN range at screening.
• Has a history of malignancy other than adequately treated basal cell or squamous cell skin cancer or cervical carcinoma within the past 2 years.
• Has a history of serious side effect or allergic response to any AngII antagonist, ERA or sparsentan, or has a hypersensitivity to any of the excipients in the study intervention.
• Requires any of the prohibited concomitant medications.
• Treatment with sparsentan within 12 weeks prior to screening
• Has participated in a study of another investigational product within 28 days prior to screening or plans to participate in such a study during the course of this study.
• Has a screening hematocrit value \<27% (0.27 Volume/Volume) or hemoglobin value \<9 g/dL (90 g/L).
• Has a screening potassium value of \>5.5 mEq/L (5.5 mmol/L).
• 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 intervention capsules whole.

Sponsors & Collaborators

• Travere Therapeutics, Inc.: lead

Study Sites (30)

Travere Investigational Site

Birmingham, Alabama, 35233, United States

Location

Travere Investigational Site

Chula Vista, California, 91910, United States

Location

Travere Investigational Site

Garden Grove, California, 92844, United States

Location

Travere Investigational Site

Glendale, California, 91206, United States

Location

Travere Investigational Site

Denver, Colorado, 80230, United States

Location

Travere Investigational Site

Boise, Idaho, 83706, United States

Location

Travere Investigational Site

Chubbuck, Idaho, 83202, United States

Location

Travere Investigational Site

Idaho Falls, Idaho, 83404, United States

Location

Travere Investigational Site

Chicago, Illinois, 60611, United States

Location

Travere Investigational Site

Evergreen Park, Illinois, 60805, United States

Location

Travere Investigational Site

Fort Wayne, Indiana, 46804, United States

Location

Travere Investigational Site

Kansas City, Kansas, 66160, United States

Location

Travere Investigational Site

Louisville, Kentucky, 40205, United States

Location

Travere Investigational Site

Shreveport, Louisiana, 71101, United States

Location

Travere Investigational Site

Albuquerque, New Mexico, 87109, United States

Location

Travere Investigation Site

Clifton Park, New York, 12065, United States

Location

Travere Investigational Site

Fresh Meadows, New York, 11365, United States

Location

Travere Investigational Site

New York, New York, 10013, United States

Location

Travere Investigational Site

Jacksonville, North Carolina, 28546, United States

Location

Travere Investigational Site

New Bern, North Carolina, 28562, United States

Location

Travere Investigational Site

Columbus, Ohio, 43210, United States

Location

Travere Investigational Site

Philadelphia, Pennsylvania, 19104, United States

Location

Travere Investigational Site

Columbia, South Carolina, 29203, United States

Location

Travere Investigational Site

Dallas, Texas, 75230, United States

Location

Travere Investigational Site

Dallas, Texas, 75246, United States

Location

Travere Investigational Site

Hong Kong, Hong Kong

Location

Travere Investigational Site

Kowloon, Hong Kong

Location

Travere Investigational Site

Shatin, Hong Kong

Location

Travere Investigational Site

Sheung Wan, Hong Kong

Location

Travere Investigational Site

Tsuen Wan, Hong Kong

Location

Related Links

• Sponsor Website

MeSH Terms

Conditions

Glomerulonephritis, IGA

Interventions

sparsentan

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Travere Therapeutics Call Center
• Organization: Travere Therapeutics, Inc.

medinfo@travere.com

1-877-659-5518

Study Officials

• Radko Komers, MD, PhD

  Travere Therapeutics, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2023
• First Posted: May 12, 2023
• Study Start: May 19, 2023
• Primary Completion: October 14, 2024
• Study Completion: October 25, 2024
• Last Updated: November 20, 2025
• Results First Posted: November 20, 2025

Record last verified: 2025-09

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
• Access Criteria: Requires submission and approval of intended use and a data sharing agreement.

Locations

US (25); HK (5)