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New kidney drug shows promise in FSGS trial

NCT ID NCT03493685

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested whether sparsentan, a drug that blocks two pathways involved in kidney damage, can better protect kidney function than the standard treatment irbesartan in people with focal segmental glomerulosclerosis (FSGS). The study enrolled 371 adults and children (ages 8-75) with biopsy-proven FSGS. Participants received either sparsentan or irbesartan daily for two years, and researchers measured changes in kidney function and protein in the urine.

What this could mean

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

Active substance
sparsentan (a drug that blocks two pathways to protect the kidneys)
What this could lead to
If successful, sparsentan could offer a new treatment option to slow kidney decline in people with FSGS, potentially delaying the need for dialysis or transplant.
What could go wrong
This is a completed Phase 3 trial, but results are not yet widely available. The drug may not prove significantly better than the existing treatment (irbesartan), 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

371 people

The number who actually took part.

Started

Apr 2018

Finished

Mar 2026

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

8 to 75 years

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: * Sites within the US and UK: The patient is male or female aged 8 to 75 years, inclusive, weighing ≥20 kg at screening * Sites outside the US and UK: The patient is male or female aged 18 to 75 years, inclusive, weighing ≥20 kg at screening * Biopsy-proven focal segmental glomerulosclerosis (FSGS) lesion(s) or documentation of a genetic mutation in a podocyte protein associated with FSGS. * Urine protein/creatinine (UP/C) ≥1.5 g/g (170 mg/mmol) at screening * eGFR ≥30 mL/min/1.73 m2 at screening. * Women of childbearing potential must agree to the use of one highly reliable method of contraception from 7 days prior to the first dose of study medication until 90 days after the last dose of study medication, plus one additional barrier method during sexual activity Key Exclusion Criteria for the Double-blind Period: * FSGS secondary to another condition * Positive serological tests of another primary or secondary glomerular disease not consistent with a diagnosis of primary or genetic FSGS * History of type 1 diabetes mellitus, uncontrolled type 2 diabetes mellitus, or nonfasting blood glucose \>180 mg/dL (10.0 mmol/L) * Treated with rituximab, cyclophosphamide, or abatacept within ≤3 months prior to screening; if taking other chronic immunosuppressive medications, the dosage must be stable prior to screening * Documented history of heart failure, coronary artery disease, or cerebrovascular disease * Significant liver disease * Positive at screening for the human immunodeficiency virus or markers indicating acute or chronic hepatitis B virus infection or hepatitis C infection * History of malignancy other than adequately treated basal cell or squamous cell skin cancer or cervical carcinoma within the past 2 years * Screening hematocrit value \<27% (0.27 L/L) or hemoglobin value \<9 g/dL (90 g/L) * Screening potassium value of \>5.5 mEq/L (5.5 mmol/L) * Extreme obesity (ie, ≥18 years of age with a body mass index (BMI) \>40, or is \<18 years of age with a BMI in the 99th percentile plus 5 units at screening, in whom there is a causal relationship between obesity and the development of FSGS * History of alcohol or illicit drug use disorder * History of serious side effect or allergic response to any angiotensin II antagonist or endothelin receptor antagonist * Female patient is pregnant, plans to become pregnant during the course of the study, or is breastfeeding. Key Inclusion Criteria for the Open-label Extension Based on assessments at the Week 108 visit: * Complete participation in the double-blind period, including the Week 112 visit. * Patient received blinded study medication through the duration of the double-blind period (ie, did not permanently discontinue study medication) Key Exclusion Criteria for the Open-label Extension Based on Assessments at Week 108 and 112 visits: * Progression to end-stage renal disease requiring replacement therapy * The patient developed criteria for discontinuation between Week 108 and Week 112 * The patient was unable to initiate, or developed contraindications to, treatment with RAAS inhibitors between Week 108 and Week 112 * eGFR ≤20 mL/min/1.73 m2 at Week 108

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Conditions

The condition(s) this trial relates to.

focal segmental glomerulosclerosis inherited focal segmental glomerulosclerosis primary focal segmental glomerulosclerosis

As listed by the trial registrant

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

Focal segmental glomerulosclerosis

Contacts and locations

Locations

  • Travere Investigational Site

    Mesa, Arizona, 85210, United States

  • Travere Investigational Site

    Phoenix, Arizona, 85027, United States

  • Travere Investigational Site

    Los Angeles, California, 90048, United States

  • Travere Investigational Site

    Northridge, California, 91324, United States

  • Travere Investigational Site

    Palo Alto, California, 94304, United States

  • Travere Investigational Site

    San Diego, California, 92103, United States

  • Travere Investigational Site

    San Dimas, California, 91773, United States

  • Travere Investigational Site

    San Francisco, California, 94118, United States

  • Travere Investigational Site

    Torrance, California, 90502, United States

  • Travere Investigational Site

    Victorville, California, 92395, United States

  • Travere Investigational Site

    Denver, Colorado, 80205, United States

  • Travere Investigational Site

    Denver, Colorado, 80230, United States

  • Travere Investigational Site

    Middlebury, Connecticut, 06762, United States

  • Travere Investigational Site

    Wilmington, Delaware, 19803, United States

  • Travere Investigational Site

    Washington D.C., District of Columbia, 20010, United States

  • Travere Investigational Site

    Coral Springs, Florida, 33071, United States

  • Travere Investigational Site

    Fort Lauderdale, Florida, 33308, United States

  • Travere Investigational Site

    Gainesville, Florida, 32610, United States

  • Travere Investigational Site

    Miami, Florida, 33126, United States

  • Travere Investigational Site

    Miami, Florida, 33136, United States

  • Travere Investigational Site

    Miami, Florida, 33155, United States

  • Travere Investigational Site

    Ocala, Florida, 34471, United States

  • Travere Investigational Site

    Orlando, Florida, 32827, United States

  • Travere Investigational Site

    Port Charlotte, Florida, 33952, United States

  • Travere Investigational Site

    Temple Terrace, Florida, 33637, United States

  • Travere Investigational Site

    Winter Park, Florida, 32789, United States

  • Travere Investigational Site

    Lawrenceville, Georgia, 30046, United States

  • Travere Investigational Site

    Nampa, Idaho, 86387, United States

  • Travere Investigational Site

    Chicago, Illinois, 60611, United States

  • Travere Investigational Site

    Hinsdale, Illinois, 60521, United States

  • Travere Investigational Site

    Kansas City, Kansas, 66160, United States

  • Travere Investigational Site

    Wichita, Kansas, 67214, United States

  • Travere Investigational Site

    Louisville, Kentucky, 40202, United States

  • Travere Investigational Site

    Monroe, Louisiana, 71201, United States

  • Travere Investigational Site

    New Orleans, Louisiana, 70121, United States

  • Travere Investigational Site

    Shreveport, Louisiana, 71101, United States

  • Travere Investigational Site

    Boston, Massachusetts, 02111, United States

  • Travere Investigational Site

    Springfield, Massachusetts, 01107, United States

  • Travere Investigational Site

    Ann Arbor, Michigan, 48109, United States

  • Travere Investigational Site

    Detroit, Michigan, 48202, United States

  • Travere Investigational Site

    Minneapolis, Minnesota, 55404, United States

  • Travere Investigational Site

    Minneapolis, Minnesota, 55455, United States

  • Travere Investigational Site

    Rochester, Minnesota, 55902, United States

  • Travere Investigational Site

    Kansas City, Missouri, 64108, United States

  • Travere Investigational Site

    Kansas City, Missouri, 64111, United States

  • Travere Investigational Site

    Las Vegas, Nevada, 89129, United States

  • Travere Investigational Site

    Reno, Nevada, 89511, United States

  • Travere Investigational Site

    Hackensack, New Jersey, 07601, United States

  • Travere Investigational Site

    Fresh Meadows, New York, 11365, United States

  • Travere Investigational Site

    New Hyde Park, New York, 11040, United States

  • Travere Investigational Site

    New York, New York, 10016, United States

  • Travere Investigational Site

    New York, New York, 10029, United States

  • Travere Investigational Site

    New York, New York, 10032, United States

  • Travere Investigational Site

    The Bronx, New York, 10467, United States

  • Travere Investigational Site

    Chapel Hill, North Carolina, 27514, United States

  • Travere Investigational Site

    Durham, North Carolina, 27710, United States

  • Travere Investigational Site

    Raleigh, North Carolina, 27609, United States

  • Travere Investigational Site

    Winston-Salem, North Carolina, 27103, United States

  • Travere Investigational Site

    Cleveland, Ohio, 44195, United States

  • Travere Investigational Site

    Columbus, Ohio, 43210, United States

  • Travere Investigational Site

    Oklahoma City, Oklahoma, 73104, United States

  • Travere Investigational Site

    Roseburg, Oregon, 97471, United States

  • Travere Investigational Site

    Bethlehem, Pennsylvania, 18017, United States

  • Travere Investigational Site

    Camp Hill, Pennsylvania, 17011, United States

  • Travere Investigational Site

    Philadelphia, Pennsylvania, 19104, United States

  • Travere Investigational Site

    Pittsburgh, Pennsylvania, 15224, United States

  • Travere Investigational Site

    Upland, Pennsylvania, 19013, United States

  • Travere Investigational Site

    Columbia, South Carolina, 29203, United States

  • Travere Investigational Site

    Memphis, Tennessee, 38103, United States

  • Travere Investigational Site

    Corpus Christi, Texas, 78412, United States

  • Travere Investigational Site

    Dallas, Texas, 75231, United States

  • Travere Investigational Site

    Dallas, Texas, 75235, United States

  • Travere Investigational Site

    Dallas, Texas, 75246, United States

  • Travere Investigational Site

    El Paso, Texas, 79902, United States

  • Travere Investigational Site

    Fort Worth, Texas, 76104, United States

  • Travere Investigational Site

    Houston, Texas, 77030, United States

  • Travere Investigational Site

    Houston, Texas, 77054, United States

  • Travere Investigational Site

    Lewisville, Texas, 75057, United States

  • Travere Investigational Site

    Sherman, Texas, 75090, United States

  • Travere Investigational Site

    Salt Lake City, Utah, 84112, United States

  • Travere Investigational Site

    Salt Lake City, Utah, 84115, United States

  • Travere Investigational Site

    St. George, Utah, 84790, United States

  • Travere Investigational Site

    Hampton, Virginia, 23666, United States

  • Travere Investigational Site

    Spokane, Washington, 99204, United States

  • Travere Investigational Site

    Morgantown, West Virginia, 26506, United States

  • Travere Investigational Site

    Marshfield, Wisconsin, 54449, United States

  • Travere Investigational Site

    Wauwatosa, Wisconsin, 53226, United States

  • Travere Investigational Site

    Buenos Aires, C1280AEB, Argentina

  • Travere Investigational Site

    Córdoba, X5000JHGQ, Argentina

  • Travere Investigational Site

    Córdoba, X5016LIG, Argentina

  • Travere Investigational Site

    Santa Fe, S3000, Argentina

  • Travere Investigational Site

    Concord, New South Wales, 2139, Australia

  • Travere Investigational Site

    New Lambton Heights, New South Wales, 2305, Australia

  • Travere Investigational Site

    Saint Leonards, New South Wales, 2065, Australia

  • Travere Investigational Site

    Wollongong, New South Wales, 2522, Australia

  • Travere Investigational Site

    Birtinya, Queensland, 4575, Australia

  • Travere Investigational Site

    Woolloongabba, Queensland, 4102, Australia

  • Travere Investigational Site

    Adelaide, South Australia, 5000, Australia

  • Travere Investigational Site

    Parkville, Victoria, 3050, Australia

  • Travere Investigational Site

    Nedlands, Western Australia, 6009, Australia

  • Travere Investigational Site

    Leuven, 3000, Belgium

  • Travere Investigational Site

    Liège, 4000, Belgium

  • Travere Investigational Site

    Roeselare, 8800, Belgium

  • Travere Investigational Site

    Botucatu, 18618-686, Brazil

  • Travere Investigational Site

    Itaquera, 08270-120, Brazil

  • Travere Investigational Site

    Passo Fundo, 99010-080, Brazil

  • Travere Investigational Site

    Porto Alegre, 90035-903, Brazil

  • Travere Investigational Site

    Recife, 50670-901, Brazil

  • Travere Investigational Site

    Rio de Janeiro, 20551-030, Brazil

  • Travere Investigational Site

    São Paulo, 04038-002, Brazil

  • Travere Investigational Site

    São Paulo, 05403-000, Brazil

  • Travere Investigational Site

    Edmonton, Alberta, T6G 2B7, Canada

  • Travere Investigational Site

    London, Ontario, N6A 5A5, Canada

  • Travere Investigational Site

    Greenfield Park, Quebec, J4V 2H1, Canada

  • Travere Investigational Site

    Zagreb, 10000, Croatia

  • Travere Investigational Site

    Prague, Prague, 100 34, Czechia

  • Travere Investigational Site

    Prague, Prague, 120 00, Czechia

  • Travere Investigational Site

    Nový Jičín, 74101, Czechia

  • Travere Investigational Site

    Aarhus, Central Jutland, 8200, Denmark

  • Travere Investigational Site

    Kolding, Southern Denmark, 6000, Denmark

  • Travere Investigational Site

    Tallinn, 10617, Estonia

  • Travere Investigational Site

    Tartu, 50406, Estonia

  • Travere Investigational Site

    Bordeaux, 33076, France

  • Travere Investigational Site

    Clermont-Ferrand, 63003, France

  • Travere Investigational Site

    Créteil, 94000, France

  • Travere Investigational Site

    Grenoble, 38043, France

  • Travere Investigational Site

    Marseille, 13005, France

  • Travere Investigational Site

    Nice, 06001, France

  • Travere Investigational Site

    Paris, 75010, France

  • Travere Investigational Site

    Paris, 75015, France

  • Travere Investigational Site

    Paris, 75743, France

  • Travere Investigational Site

    Saint-Priest-en-Jarez, 42270, France

  • Travere Investigational Site

    Toulouse, 31059, France

  • Travere Investigational Site

    Valenciennes, 59322, France

  • Travere Investigational Site

    Düsseldorf, Westfalen, 40210, Germany

  • Travere Investigational Site

    Aachen, 52074, Germany

  • Travere Investigational Site

    Berlin, 10117, Germany

  • Travere Investigational Site

    Berlin, 12203, Germany

  • Travere Investigational Site

    Hanover, 30625, Germany

  • Travere Investigational Site

    Stuttgart, 70376, Germany

  • Travere Investigational Site

    Villingen-Schwenningen, 78052, Germany

  • Travere Investigational Site

    Hong Kong, Hong Kong

  • Travere Investigational Site

    Lai Chi Kok, Hong Kong

  • Travere Investigational Site

    Bari, 70124, Italy

  • Travere Investigational Site

    Bergamo, 24127, Italy

  • Travere Investigational Site

    Bologna, 40138, Italy

  • Travere Investigational Site

    Florence, 50134, Italy

  • Travere Investigational Site

    Genova, 16132, Italy

  • Travere Investigational Site

    Germaneto, 88100, Italy

  • Travere Investigational Site

    Lecco, 23900, Italy

  • Travere Investigational Site

    Milan, 20122, Italy

  • Travere Investigational Site

    Monza, 20900, Italy

  • Travere Investigational Site

    Pavia, 27100, Italy

  • Travere Investigational Site

    Roma, 168, Italy

  • Travere Investigational Site

    Verona, 37126, Italy

  • Travere Investigational Site

    Auckland, 1051, New Zealand

  • Travere Investigational Site

    Hamilton, 3204, New Zealand

  • Travere Investigational Site

    Lodz, 93-347, Poland

  • Travere Investigational Site

    Olsztyn, 10-117, Poland

  • Travere Investigational Site

    Olsztyn, 10-561, Poland

  • Travere Investigational Site

    Piotrkow Trybunalski, 97-300, Poland

  • Travere Investigational Site

    Warsaw, 00-631, Poland

  • Travere Investigational Site

    Warsaw, 04-749, Poland

  • Travere Investigational Site

    Wroclaw, 50-556, Poland

  • Travere Investigational Site

    Amadora, 2720-276, Portugal

  • Travere Investigational Site

    Carnaxide, 2790-134, Portugal

  • Travere Investigational Site

    Lisbon, 1050-099, Portugal

  • Travere Investigational Site

    Lisbon, 1649-035, Portugal

  • Travere Investigational Site

    Loures, 2674-514, Portugal

  • Travere Investigational Site

    Porto, 4200-319, Portugal

  • Travere Investigational Site

    Setúbal, 2910-446, Portugal

  • Travere Investigational Site

    Vila Nova de Gaia, 4434-502, Portugal

  • Travere Investigational Site

    Busan, 47392, South Korea

  • Travere Investigational Site

    Daejeon, 35015, South Korea

  • Travere Investigational Site

    Gyeonggi-do, 13620, South Korea

  • Travere Investigational Site

    Gyeonggi-do, 14068, South Korea

  • Travere Investigational Site

    Seoul, 3080, South Korea

  • Travere Investigational Site

    Seoul, 3722, South Korea

  • Travere Investigational Site

    Palma de Mallorca, Balearic Islands, 07120, Spain

  • Travere Investigational Site

    Lugo, Burela, 27880, Spain

  • Travere Investigational Site

    Sagunto, Valencia, 46520, Spain

  • Travere Investigational Site

    Badalona, 8916, 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

    Ciudad Real, 13005, Spain

  • Travere Investigational Site

    Córdoba, 14004, Spain

  • Travere Investigational Site

    Madrid, 28040, Spain

  • Travere Investigational Site

    Madrid, 28041, Spain

  • Travere Investigational Site

    Majadahonda, 28222, Spain

  • Travere Investigational Site

    Málaga, 29010, Spain

  • Travere Investigational Site

    Santiago de Compostela, 15706, Spain

  • Travere Investigational Site

    Seville, 41009, Spain

  • Travere Investigational Site

    Seville, 41013, Spain

  • Travere Investigational Site

    Valencia, 46014, Spain

  • Travere Investigational Site

    Valencia, 46017, Spain

  • Travere Investigational Site

    Zaragoza, 50009, Spain

  • Travere Investigational Site

    Solna, SE-171 64, Sweden

  • Travere Investigational Site

    Uppsala, 75237, Sweden

  • Travere Investigational Site

    Uppsala, SE-751 85, Sweden

  • Travere Investigational Site

    Hualien City, 970, Taiwan

  • Travere Investigational Site

    Kaohsiung City, 81362, Taiwan

  • Travere Investigational Site

    New Taipei City, 235, Taiwan

  • Travere Investigational Site

    Taichung, 404, Taiwan

  • Travere Investigational Site

    Taichung, 40705, Taiwan

  • Travere Investigational Site

    Tainan, 710, Taiwan

  • Travere Investigational Site

    Taipei, 10048, Taiwan

  • Travere Investigational Site

    Taipei, 104, Taiwan

  • Travere Investigational Site

    Taipei, 110, Taiwan

  • Travere Investigational Site

    Taoyuan, 333, Taiwan

  • Travere Investigational Site

    Carshalton, London, SM5 1AA, United Kingdom

  • Travere Investigational Site

    Whitechapel, London, E1 1BB, United Kingdom

  • Travere Investigational Site

    Fulwood, Preston, PR2 9HT, United Kingdom

  • Travere Investigational Site

    Brighton, BN2 5BE, United Kingdom

  • Travere Investigational Site

    Cambridge, CB2 0QQ, United Kingdom

  • Travere Investigational Site

    Cardiff, CF14 4XW, United Kingdom

  • Travere Investigational Site

    Leicester, LE5 4PW, United Kingdom

  • Travere Investigational Site

    London, NW3 2QG, United Kingdom

  • Travere Investigational Site

    London, SE5 9RS, United Kingdom

  • Travere Investigational Site

    Manchester, M13 9WL, United Kingdom

  • Travere Investigational Site

    Newcastle, NE7 7DN, United Kingdom

  • Travere Investigational Site

    Reading, RG1 5AN, United Kingdom

  • Travere Investigational Site

    Salford, M6 8HD, United Kingdom

  • Travere Investigational Site

    Swansea, SA6 6NL, United Kingdom

  • Travere Investigational Site

    York, YO31 8HE, United Kingdom

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