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New drug aims to protect kidneys in IgA nephropathy patients

NCT ID NCT03762850

Disease control Sponsor: Travere Therapeutics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 trial tests sparsentan, a new drug, against irbesartan (a standard treatment) in 406 adults with IgA nephropathy, a kidney disease. The goal is to see if sparsentan better protects kidney function over about 2 years. Participants must have significant protein in their urine and stable kidney function at the start.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
sparsentan
What this could lead to
If successful, sparsentan could offer a new treatment option to slow kidney function decline in people with IgA nephropathy.
What could go wrong
This is a Phase 3 trial, but results are not yet final. The drug may not prove significantly better than existing treatments, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

406 people

The number who actually took part.

Started

Dec 2018

Expected to finish

Jul 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria for the Double-Blind Period: * Age 18 years or older at screening * Biopsy-proven primary IgAN * Proteinuria of ≥1 g/day at screening * eGFR ≥30 mL/min/1.73 m2 at screening * Currently on stable dose of ACEI and/or ARB therapy, for at least 12 weeks prior to screening (maximum tolerated dose and at least one-half of the maximum labeled dose) * Systolic BP ≤150 mmHg and diastolic BP ≤100 mmHg at screening * Willing to undergo change in ACEI and/or ARB and anti-hypertensive medications * Agree to contraception Key Exclusion Criteria for the Double-Blind Period: * IgAN secondary to another condition * Presence of cellular glomerular crescents in \>25% of glomeruli on renal biopsy (if biopsy available within 6 months of screening) * Chronic kidney disease (CKD) in addition to IgAN * History of organ transplantation, with exception of corneal transplants * Require any prohibited medications * Treatment of systemic immunosuppressive medications (including corticosteroids) for \>2 weeks within 3 months of screening * History of heart failure or previous hospitalization for heart failure or unexplained dyspnea, orthopnea, paroxysmal nocturnal dyspnea, ascites, and/or peripheral edema * Clinically significant cerebrovascular disease or coronary artery disease within 6 months of screening * Jaundice, hepatitis, or known hepatobiliary disease or elevations of transaminases (ALT/AST) \>2 times upper limit of normal at screening * History of malignancy other than adequately treated basal cell or squamous cell skin cancer or cervical carcinoma within the past 2 years * Hematocrit value \<27% (0.27 V/V) or hemoglobin value \<9 g/dL (90 g/L) at Screening * Potassium \>5.5 mEq/L (5.5 mmol/L) at Screening * History of alcohol of illicit drug use disorder * History of serious side effect or allergic response to any angiotensin II antagonist or endothelin receptor antagonist, including sparsentan or irbesartan, or has a hypersensitivity to any of the excipients in the study medications * For female: Pregnancy, or planning to become pregnant during the course of the study, or breastfeeding * Participation in a study of another investigational product within 28 days of screening Key Inclusion Criteria for the Open-Label Extension Period based on assessments at the Week 110 visit: * Completed participation in the double-blind period, including the Week 114 visit * Did not permanently discontinue study medication during the double-blind period * Agree to contraception Key Exclusion Criteria for the Open-Label Extension Period based on assessments at the Week 110 and Week 114 visits: * Progression to end-stage renal disease (ESRD) requiring renal replacement therapy (RRT) * Development of any criteria for discontinuation of study medication or discontinuation from the study, between Week 110 and Week 114 * Patient was unable to initiate, or developed contraindications to, treatment with RAAS inhibitors between Week 110 and Week 114 * eGFR ≤20 mL/min/1.73 m2 at Week 110 * Female patient is pregnant or breastfeeding Key Inclusion Criteria for the OLE Sparsentan + SGLT2 Inhibitor Sub study: * Participating in the open-label extension and is willing and able to provide signed informed consent for participation in the open-label extension period Sub study * A urine protein excretion value of ≥0.3 g/day. * An eGFR of ≥25 mL/min/1.73m2 * On a stable dose of sparsentan for ≥8 weeks in the open-label extension period that is the maximum tolerated dose. Key Exclusion Criteria for the OLE Sparsentan + SGLT2 Inhibitor Sub study: * Progressed to ESRD requiring RRT * Initiated or changed dose of a systemic immunosuppressive medication (including systemic steroids) within 12 weeks * Taking an SGLT2 inhibitor within 12 weeks

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Conditions

The condition(s) this trial relates to.

IgA glomerulonephritis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Immunoglobulin A nephropathy

Contacts and locations

Locations

  • Travere Investigational Site

    Birmingham, Alabama, 35233, United States

  • Travere Investigational Site

    Homewood, Alabama, 35209, United States

  • Travere Investigational Site

    Glendale, California, 91206, United States

  • Travere Investigational Site

    Montebello, California, 90640, United States

  • Travere Investigational Site

    Northridge, California, 91324, United States

  • Travere Investigational Site

    San Diego, California, 92103-6204, United States

  • Travere Investigational Site

    San Diego, California, 92103, United States

  • Travere Investigational Site

    Stanford, California, 94205, United States

  • Travere Investigational Site

    Denver, Colorado, 80230, United States

  • Travere Investigational Site

    Coral Springs, Florida, 33071, United States

  • Travere Investigational Site

    Hollywood, Florida, 33021, United States

  • Travere Investigational Site

    Miami, Florida, 33136, United States

  • Travere Investigational Site

    Miami, Florida, 33186, United States

  • Travere Investigational Site

    Winter Park, Florida, 32789, United States

  • Travere Investigational Site

    Lawrenceville, Georgia, 30046, United States

  • Travere Investigational Site

    Nampa, Idaho, 83687, United States

  • Travere Investigational Site

    Hinsdale, Illinois, 60521, United States

  • Travere Investigational Site

    Muncie, Indiana, 47303, United States

  • Travere Investigational Site

    Kansas City, Kansas, 66160, United States

  • Travere Investigational Site

    Louisville, Kentucky, 40202, United States

  • Travere Investigational Site

    Boston, Massachusetts, 02215, United States

  • Travere Investigational Site

    Springfield, Massachusetts, 01104, United States

  • Travere Investigational Site

    Worcester, Massachusetts, 01608, United States

  • Travere Investigational Site

    Minneapolis, Minnesota, 55404, United States

  • Travere Investigational Site

    Reno, Nevada, 89511, United States

  • Travere Investigational Site

    Fresh Meadows, New York, 11365, United States

  • Travere Investigational Site

    New York, New York, 10032, United States

  • Travere Investigational Site

    Cleveland, Ohio, 44106, United States

  • Travere Investigational Site

    Columbus, Ohio, 43210, United States

  • Travere Investigational Site

    Philadelphia, Pennsylvania, 19104, United States

  • Travere Investigational Site

    Columbia, South Carolina, 29203, United States

  • Travere Investigational Site

    El Paso, Texas, 79935, United States

  • Travere Investigational Site

    Fort Worth, Texas, 76104, United States

  • Travere Investigational Site

    Houston, Texas, 77054, United States

  • Travere Investigational Site

    Lewisville, Texas, 75057, United States

  • Travere Investigational Site

    San Antonio, Texas, 78207, United States

  • Travere Investigational Site

    Salt Lake City, Utah, 84115, United States

  • Travere Investigational Site

    Salt Lake City, Utah, 84132, United States

  • Travere Investigational Site

    Tacoma, Washington, 98405, United States

  • Travere Investigational Site

    Marshfield, Wisconsin, 54449, United States

  • Travere Investigational Site

    Concord, New South Wales, 2139, Australia

  • Travere Investigational Site

    Gosford, New South Wales, 2250, Australia

  • Travere Investigational Site

    Kingswood, New South Wales, 2747, Australia

  • Travere Investigational Site

    New Lambton Heights, New South Wales, 2305, Australia

  • Travere Investigational Site

    Randwick, New South Wales, 2031, Australia

  • Travere Investigational Site

    St Leonards, New South Wales, 2065, Australia

  • Travere Investigational Site

    Birtinya, Queensland, 4575, Australia

  • Travere Investigational Site

    Adelaide, South Australia, 5000, Australia

  • Travere Investigational Site

    Reservoir, Victoria, 3073, Australia

  • Travere Investigational Site

    Nedlands, Western Australia, 6009, Australia

  • Travere Investigational Site

    Bonheiden, 2820, Belgium

  • Travere Investigational Site

    Bruges, 8310, Belgium

  • Travere Investigational Site

    Ghent, 9000, Belgium

  • Travere Investigational Site

    Kortrijk, 8500, Belgium

  • Travere Investigational Site

    Liège, 4000, Belgium

  • Travere Investigational Site

    Roeselare, 8800, Belgium

  • Travere Investigational Site

    Osijek, 31000, Croatia

  • Travere Investigational Site

    Zagreb, 10000, Croatia

  • Travere Investigational Site

    Prague, 10034, Czechia

  • Travere Investigational Site

    Prague, 12808, Czechia

  • Travere Investigational Site

    Tallinn, 10617, Estonia

  • Travere Investigational Site

    Tallinn, 13419, Estonia

  • Travere Investigational Site

    Tartu, 50406, Estonia

  • Travere Investigational Site

    Marseille, Bouches-du-Rhone, 13005, France

  • Travere Investigational Site

    Montpellier, Herault, 34295, France

  • Travere Investigational Site

    Grenoble, Isere, 38043, France

  • Travere Investigational Site

    Paris, Paris, 75015, France

  • Travere Investigational Site

    Saint-Priest-en-Jarez, Pays de la Loire Region, 42270, France

  • Travere Investigational Site

    Clermont-Ferrand, Puy De Dome, 63003, France

  • Travere Investigational Site

    Créteil, 94010, France

  • Travere Investigational Site

    Paris, 75475, France

  • Travere Investigational Site

    Villingen-Schwenningen, Baden-Wurttemberg, 78052, Germany

  • Travere Investigational Site

    Hanover, Lower Saxony, 30625, Germany

  • Travere Investigational Site

    Aachen, North Rhine-Westphalia, 52074, Germany

  • Travere Investigational Site

    Düsseldorf, North Rhine-Westphalia, 40210, Germany

  • Travere Investigational Site

    Kaiserslautern, Rheinland Palatinate, 67655, Germany

  • Travere Investigational Site

    Trier, Rheinland Palatinate, 54292, Germany

  • Travere Investigational Site

    Kiel, Schleswig-Holstein, 23538, Germany

  • Travere Investigational Site

    Kiel, Schleswig-Holstein, 24105, Germany

  • Travere Investigational Site

    Jena, Thuringia, 07747, Germany

  • Travere Investigational Site

    Berlin, 10117, Germany

  • Travere Investigational Site

    Kwun Tong, Kowloon, Hong Kong

  • Travere Investigational Site

    Lai Chi Kok, Kowloon, Hong Kong

  • Travere Investigational Site

    Shatin, New Territories, Hong Kong

  • Travere Investigational Site

    Tsuen Wan, New Territories, Hong Kong

  • Travere Investigational Site

    Hong Kong, Hong Kong

  • Travere Investigational Site

    Ranica, Bergamo, 24020, Italy

  • Travere Investigational Site

    Milan, Lombardy, 20162, Italy

  • Travere Investigational Site

    Bari, 70124, Italy

  • Travere Investigational Site

    Catania, 95123, Italy

  • Travere Investigational Site

    Catanzaro, 88100, Italy

  • Travere Investigational Site

    Lecco, 23900, Italy

  • Travere Investigational Site

    Modena, 41124, Italy

  • Travere Investigational Site

    Pavia, 27100, Italy

  • Travere Investigational Site

    Roma, 00168, Italy

  • Travere Investigational Site

    Torino, 10126, Italy

  • Travere Investigational Site

    Kaunas, LT-50009, Lithuania

  • Travere Investigational Site

    Vilnius, LT-08661, Lithuania

  • Travere Investigational Site

    Grafton, Auckland, 1142, New Zealand

  • Travere Investigational Site

    Hamilton, 3200, New Zealand

  • Travere Investigational Site

    Hastings, 4120, New Zealand

  • Travere Investigational Site

    New Plymouth, 4310, New Zealand

  • Travere Investigational Site

    Krakow, 31-559, Poland

  • Travere Investigational Site

    Lodz, 93-347, Poland

  • Travere Investigational Site

    Olsztyn, 10-124, Poland

  • Travere Investigational Site

    Olsztyn, 10-561, Poland

  • Travere Investigational Site

    Warsaw, 04-749, Poland

  • Travere Investigational Site

    Wroclaw, 50-566, Poland

  • Travere Investigational Site

    Coimbra, 3000-075, Portugal

  • Travere Investigational Site

    Lisbon, 1069-166, Portugal

  • Travere Investigational Site

    Lisbon, 1649-035, Portugal

  • Travere Investigational Site

    Loures, 2674-514, Portugal

  • Travere Investigational Site

    Setúbal, 2910-446, Portugal

  • Travere Investigational Site

    Vila Nova de Gaia, 4434-502, Portugal

  • Travere Investigational Site

    Seongnam-si, Gyeonggi-do, 13620, South Korea

  • Travere Investigational Site

    Anyang-si, 14068, South Korea

  • Travere Investigational Site

    Busan, 47392, South Korea

  • Travere Investigational Site

    Incheon, 21565, South Korea

  • Travere Investigational Site

    Seoul, 02841, South Korea

  • Travere Investigational Site

    Seoul, 03080, South Korea

  • Travere Investigational Site

    Seoul, 06273, South Korea

  • Travere Investigational Site

    Seoul, 110-746, South Korea

  • Travere Investigational Site

    Seoul, 120-752, South Korea

  • Travere Investigational Site

    Seoul, 135-710, South Korea

  • Travere Investigational Site

    Palma de Mallorca, Balearic Islands, 07120, Spain

  • Travere Investigational Site

    Sagunto, Valencia, 46520, Spain

  • Travere Investigational Site

    Barcelona, 08003, Spain

  • Travere Investigational Site

    Barcelona, 08025, Spain

  • Travere Investigational Site

    Barcelona, 08035, Spain

  • Travere Investigational Site

    Barcelona, 08036, Spain

  • Travere Investigational Site

    Madrid, 28007, Spain

  • Travere Investigational Site

    Madrid, 28040, Spain

  • Travere Investigational Site

    Madrid, 28041, Spain

  • Travere Investigational Site

    Seville, 41009, Spain

  • Travere Investigational Site

    Valencia, 46014, Spain

  • Travere Investigational Site

    Valencia, 46017, Spain

  • Travere Investigational Site

    Zaragoza, 50009, Spain

  • Travere Investigational Site

    Hualien City, 970, Taiwan

  • Travere Investigational Site

    Kaohsiung City, 807, Taiwan

  • Travere Investigational Site

    Kaohsiung City, 81362, Taiwan

  • Travere Investigational Site

    New Taipei City, 220, Taiwan

  • Travere Investigational Site

    Taichung, 40705, Taiwan

  • Travere Investigational Site

    Reading, Berkshire, RG1 5AN, United Kingdom

  • Travere Investigational Site

    Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

  • Travere Investigational Site

    Middlesbrough, Cleveland, TS4 3BW, United Kingdom

  • Travere Investigational Site

    Derby, Derbyshire, DE22 3DT, United Kingdom

  • Travere Investigational Site

    Brighton, East Sussex, BN2 5BE, United Kingdom

  • Travere Investigational Site

    London, Greater London, E1 4AT, United Kingdom

  • Travere Investigational Site

    London, Greater London, SE1 9RT, United Kingdom

  • Travere Investigational Site

    Manchester, Greater Manchester, M13 9WL, United Kingdom

  • Travere Investigational Site

    Salford, Greater Manchester, M6 8HD, United Kingdom

  • Travere Investigational Site

    Preston, Lancashire, PR2 9HT, United Kingdom

  • Travere Investigational Site

    Leicester, Leicestershire, LE5 4PW, United Kingdom

  • Travere Investigational Site

    Edinburgh, Scotland, EH16 4SA, United Kingdom

  • Travere Investigational Site

    Stoke-on-Trent, Staffordshire, ST4 6QG, United Kingdom

  • Travere Investigational Site

    Glasgow, Strathclyde, G11 6NT, United Kingdom

  • Travere Investigational Site

    Carshalton, Surrey, SM5 1AA, United Kingdom

  • Travere Investigational Site

    Cardiff, West Glamorgan, CF14 4XW, United Kingdom

  • Travere Investigational Site

    Birmingham, West Midlands, B9 5SS, United Kingdom

  • Travere Investigational Site

    Liverpool, L9 7AL, United Kingdom

  • Travere Investigational Site

    London, E1 1FR, United Kingdom

  • Travere Investigational Site

    London, SE5 9RS, United Kingdom

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