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

Last updated: November 6, 2025
Sponsor: Travere Therapeutics, Inc.
Overall Status: Completed

Phase

2

Condition

Glomerulonephritis

Treatment

Sparsentan

Clinical Study ID

NCT05856760
TVTX-RE021-204
  • Ages > 18
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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 screeningthat 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 ≤10mg/day prednisone or equivalent), or an enteric formulation of budesonide and/or amineralocorticoid receptor antagonist (MRA), the dosage must be stable for ≥12 weeksprior to screening.

Exclusion

Exclusion Criteria:

  • 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 systemicimmunosuppressive medications within 12 weeks of prior to screening.

  • Has clinically significant cerebrovascular disease (transient ischemic attack orstroke) and/or coronary artery disease (hospitalization for myocardial infarctionunstable angina, new onset of angina with positive functional tests, coronaryangiogram revealing stenosis, or a coronary revascularization procedure) within 3months prior to screening.

  • Has jaundice, hepatitis, or known hepatobiliary disease (excluding asymptomaticcholelithiasis), or ALT and/or AST >2 times the ULN range at screening.

  • Has a history of malignancy other than adequately treated basal cell or squamouscell 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 studyintervention.

  • 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 priorto screening or plans to participate in such a study during the course of thisstudy.

  • Has a screening hematocrit value <27% (0.27 Volume/Volume) or hemoglobin value <9g/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 isbreastfeeding.

  • The participant, in the opinion of the Investigator, is unable to adhere to therequirements of the study, including the ability to swallow the study interventioncapsules whole.

Study Design

Total Participants: 48
Treatment Group(s): 1
Primary Treatment: Sparsentan
Phase: 2
Study Start date:
May 19, 2023
Estimated Completion Date:
October 25, 2024

Study Description

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 Immunoglobulin A Nephropathy (IgAN) who are at risk of disease progression to kidney failure (KF) despite being on both stable renin angiotensin aldosterone system inhibitor (RAASi) and sodium glucose cotransporter-2 (SGLT2) inhibitor treatment for at least 12 weeks prior to study entry.

Participants who provided written informed consent were assessed for eligibility and underwent baseline evaluations including clinical laboratory tests. Per the eligibility criteria, all participants were required to be on a stable dose(s) of angiotensin converting enzyme inhibitor (ACEI) and/or angiotensin receptor blocker (ARB) and on a stable dose of a SGLT2 inhibitor at screening and continued their stable treatments through the screening period. Eligible participants discontinued ACEI and/or ARB therapy the day before the Day 1 visit and remained on stable SGLT2 inhibitor dosing for the duration of the study.

Study intervention was administered daily for a treatment period of 24 weeks with study visits conducted at weeks 2-, 4-, 12-, and 24- following Day 1. Following the 24-week treatment period, study intervention was discontinued for 4 weeks and standard of care RAASi treatment resumed, with a safety visit at Week 28.

Connect with a study center

  • Travere Investigational Site

    Hong Kong,
    Hong Kong

    Site Not Available

  • Travere Investigational Site

    Hong Kong 1819729,
    Hong Kong

    Site Not Available

  • Travere Investigational Site

    Kowloon,
    Hong Kong

    Site Not Available

  • Travere Investigational Site

    Kowloon 1819609,
    Hong Kong

    Site Not Available

  • Travere Investigational Site

    Shatin,
    Hong Kong

    Site Not Available

  • Travere Investigational Site

    Shatin 1818920,
    Hong Kong

    Site Not Available

  • Travere Investigational Site

    Sheung Wan,
    Hong Kong

    Site Not Available

  • Travere Investigational Site

    Sheung Wan 1818833,
    Hong Kong

    Site Not Available

  • Travere Investigational Site

    Tsuen Wan,
    Hong Kong

    Site Not Available

  • Travere Investigational Site

    Tsuen Wan 1818209,
    Hong Kong

    Site Not Available

  • Travere Investigational Site

    Birmingham, Alabama 35233
    United States

    Site Not Available

  • Travere Investigational Site

    Birmingham 4049979, Alabama 4829764 35233
    United States

    Site Not Available

  • Travere Investigational Site

    Chula Vista, California 91910
    United States

    Site Not Available

  • Travere Investigational Site

    Garden Grove, California 92844
    United States

    Site Not Available

  • Travere Investigational Site

    Glendale, California 91206
    United States

    Site Not Available

  • Travere Investigational Site

    Chula Vista 5336899, California 5332921 91910
    United States

    Site Not Available

  • Travere Investigational Site

    Garden Grove 5351515, California 5332921 92844
    United States

    Site Not Available

  • Travere Investigational Site

    Glendale 5352423, California 5332921 91206
    United States

    Site Not Available

  • Travere Investigational Site

    Denver, Colorado 80230
    United States

    Site Not Available

  • Travere Investigational Site

    Denver 5419384, Colorado 5417618 80230
    United States

    Site Not Available

  • Travere Investigational Site

    Boise, Idaho 83706
    United States

    Site Not Available

  • Travere Investigational Site

    Chubbuck, Idaho 83202
    United States

    Site Not Available

  • Travere Investigational Site

    Idaho Falls, Idaho 83404
    United States

    Site Not Available

  • Travere Investigational Site

    Nampa, Idaho 83687
    United States

    Site Not Available

  • Travere Investigational Site

    Boise 5586437, Idaho 5596512 83706
    United States

    Site Not Available

  • Travere Investigational Site

    Chubbuck 5588842, Idaho 5596512 83202
    United States

    Site Not Available

  • Travere Investigational Site

    Idaho Falls 5596475, Idaho 5596512 83404
    United States

    Site Not Available

  • Travere Investigational Site

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Travere Investigational Site

    Evergreen Park, Illinois 60805
    United States

    Site Not Available

  • Travere Investigational Site

    Chicago 4887398, Illinois 4896861 60611
    United States

    Site Not Available

  • Travere Investigational Site

    Evergreen Park 4891431, Illinois 4896861 60805
    United States

    Site Not Available

  • Travere Investigational Site

    Fort Wayne, Indiana 46804
    United States

    Site Not Available

  • Travere Investigational Site

    Fort Wayne 4920423, Indiana 4921868 46804
    United States

    Site Not Available

  • Travere Investigational Site

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • Travere Investigational Site

    Kansas City 4273837, Kansas 4273857 66160
    United States

    Site Not Available

  • Travere Investigational Site

    Louisville, Kentucky 40205
    United States

    Site Not Available

  • Travere Investigational Site

    Louisville 4299276, Kentucky 6254925 40205
    United States

    Site Not Available

  • Travere Investigational Site

    Shreveport, Louisiana 71101
    United States

    Site Not Available

  • Travere Investigational Site

    Shreveport 4341513, Louisiana 4331987 71101
    United States

    Site Not Available

  • Travere Investigational Site

    Albuquerque, New Mexico 87109
    United States

    Site Not Available

  • Travere Investigational Site

    Albuquerque 5454711, New Mexico 5481136 87109
    United States

    Site Not Available

  • Travere Investigation SIte

    Clifton Park, New York 12065
    United States

    Site Not Available

  • Travere Investigational Site

    Fresh Meadows, New York 11365
    United States

    Site Not Available

  • Travere Investigational Site

    New York, New York 10013
    United States

    Site Not Available

  • Travere Investigation Site

    Clifton Park 5112961, New York 5128638 12065
    United States

    Site Not Available

  • Travere Investigational Site

    Fresh Meadows 5118005, New York 5128638 11365
    United States

    Site Not Available

  • Travere Investigational Site

    New York 5128581, New York 5128638 10013
    United States

    Site Not Available

  • Travere Investigational Site

    Jacksonville, North Carolina 28546
    United States

    Site Not Available

  • Travere Investigational Site

    New Bern, North Carolina 28562
    United States

    Site Not Available

  • Travere Investigational Site

    Jacksonville 4473083, North Carolina 4482348 28546
    United States

    Site Not Available

  • Travere Investigational Site

    New Bern 4481682, North Carolina 4482348 28562
    United States

    Site Not Available

  • Travere Investigational Site

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Travere Investigational Site

    Columbus 4509177, Ohio 5165418 43210
    United States

    Site Not Available

  • Travere Investigational Site

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Travere Investigational Site

    Philadelphia 4560349, Pennsylvania 6254927 19104
    United States

    Site Not Available

  • Travere Investigational Site

    Columbia, South Carolina 29203
    United States

    Site Not Available

  • Travere Investigational Site

    Columbia 4575352, South Carolina 4597040 29203
    United States

    Site Not Available

  • Travere Investigational Site

    Dallas, Texas 75230
    United States

    Site Not Available

  • Travere Investigational Site

    Dallas 4684888, Texas 4736286 75246
    United States

    Site Not Available

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