Study of Sparsentan in Patients With Primary Focal Segmental Glomerulosclerosis (FSGS)

NCT ID: NCT03493685

Last Updated: 2025-06-12

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 371 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-17
• Study Completion Date: 2026-02-28

Brief Summary

To determine the long-term nephroprotective potential of treatment with sparsentan as compared to an angiotensin receptor blocker in patients with primary and genetic focal segmental glomerulosclerosis (FSGS).

Detailed Description

This is a randomized, multicenter, double-blind, parallel, active-control study. Approximately 300 patients aged 8 to 75 years (inclusive) will be enrolled in the study. The study will be conducted in approximately 300 study centers, globally. The investigational drug (sparsentan) is a dual-acting angiotensin receptor blocker and endothelin receptor antagonist. The active control is irbesartan. Patients who meet eligibility criteria will require washout from renin-angiotensin-aldosterone system (RAAS) blockers, if applicable prior to their first dose of study drug.

Patients will be randomly assigned in a 1:1 ratio to receive either sparsentan or active control (irbesartan).

After completing the double-blind portion of the study, patients may participate in the open-label extension for treatment with sparsentan if they meet eligibility criteria.

Primary completion date represents the anticipated completion date of the double-blind portion of the study. Study completion date represents the anticipated completion date of the open-label extension portion of the study.

Conditions

Focal Segmental Glomerulosclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

sparsentan for double-blind and open-label extension

Sparsentan will be administered as a single oral dose; an initial dose of 400 mg daily titrating up to a target dose of 800 mg, daily

Group Type: EXPERIMENTAL

sparsentan

Intervention Type: DRUG

Double-blind period: target dose of 800 mg daily; Open-label extension: target dose based on dosage from week 114 daily

Irbesartan

Irbesartan will be administered as a single oral dose; an initial dose of 150 mg daily titrating up to a target dose of 300 mg, daily

Group Type: ACTIVE_COMPARATOR

Irbesartan

Intervention Type: DRUG

target dose of 300 mg daily

Interventions

sparsentan

Double-blind period: target dose of 800 mg daily; Open-label extension: target dose based on dosage from week 114 daily

Intervention Type: DRUG

Irbesartan

target dose of 300 mg daily

Intervention Type: DRUG

Other Intervention Names

RE-021; Irbesartan Tablets USP

Eligibility Criteria

Inclusion Criteria

• 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

• 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)

Exclusion Criteria

• 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.

• 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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Travere Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Radko Komers, MD, PhD

Role: STUDY_DIRECTOR

Travere Therapeutics, Inc.

Locations

Travere Investigational Site

Dallas, Texas, United States

Travere Investigational Site

Dallas, Texas, United States

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Dallas, Texas, United States

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Solna, , Sweden

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Uppsala, , Sweden

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Uppsala, , Sweden

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Hualien City, , Taiwan

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Kaohsiung City, , Taiwan

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New Taipei City, , Taiwan

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Taichung, , Taiwan

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Taichung, , Taiwan

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Tainan City, , Taiwan

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Taipei, , Taiwan

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Taipei, , Taiwan

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Taipei, , Taiwan

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Taoyuan District, , Taiwan

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Mesa, Arizona, United States

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Phoenix, Arizona, United States

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Los Angeles, California, United States

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Northridge, California, United States

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Palo Alto, California, United States

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San Diego, California, United States

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San Dimas, California, United States

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San Francisco, California, United States

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Torrance, California, United States

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Victorville, California, United States

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Denver, Colorado, United States

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Denver, Colorado, United States

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Middlebury, Connecticut, United States

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Wilmington, Delaware, United States

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

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Coral Springs, Florida, United States

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Fort Lauderdale, Florida, United States

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Gainesville, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Ocala, Florida, United States

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Orlando, Florida, United States

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Port Charlotte, Florida, United States

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Temple Terrace, Florida, United States

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Winter Park, Florida, United States

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Lawrenceville, Georgia, United States

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Nampa, Idaho, United States

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Chicago, Illinois, United States

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Hinsdale, Illinois, United States

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Kansas City, Kansas, United States

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Wichita, Kansas, United States

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Louisville, Kentucky, United States

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Monroe, Louisiana, United States

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New Orleans, Louisiana, United States

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Shreveport, Louisiana, United States

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Boston, Massachusetts, United States

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Springfield, Massachusetts, United States

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Ann Arbor, Michigan, United States

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Detroit, Michigan, United States

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Minneapolis, Minnesota, United States

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Minneapolis, Minnesota, United States

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Rochester, Minnesota, United States

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Kansas City, Missouri, United States

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Kansas City, Missouri, United States

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Las Vegas, Nevada, United States

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Reno, Nevada, United States

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Hackensack, New Jersey, United States

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Fresh Meadows, New York, United States

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New Hyde Park, New York, United States

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New York, New York, United States

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New York, New York, United States

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New York, New York, United States

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The Bronx, New York, United States

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Chapel Hill, North Carolina, United States

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Durham, North Carolina, United States

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Raleigh, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Cleveland, Ohio, United States

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Columbus, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Roseburg, Oregon, United States

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Bethlehem, Pennsylvania, United States

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Camp Hill, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Upland, Pennsylvania, United States

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Columbia, South Carolina, United States

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Corpus Christi, Texas, United States

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El Paso, Texas, United States

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Fort Worth, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Lewisville, Texas, United States

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Sherman, Texas, United States

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Salt Lake City, Utah, United States

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Salt Lake City, Utah, United States

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St. George, Utah, United States

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Hampton, Virginia, United States

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Spokane, Washington, United States

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Morgantown, West Virginia, United States

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Marshfield, Wisconsin, United States

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Wauwatosa, Wisconsin, United States

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Buenos Aires, , Argentina

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Córdoba, , Argentina

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Córdoba, , Argentina

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Santa Fe, , Argentina

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Concord, New South Wales, Australia

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New Lambton Heights, New South Wales, Australia

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Saint Leonards, New South Wales, Australia

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Wollongong, New South Wales, Australia

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Birtinya, Queensland, Australia

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Woolloongabba, Queensland, Australia

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Adelaide, South Australia, Australia

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Parkville, Victoria, Australia

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Nedlands, Western Australia, Australia

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Leuven, , Belgium

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Liège, , Belgium

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Roeselare, , Belgium

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Botucatu, , Brazil

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Itaquera, , Brazil

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Passo Fundo, , Brazil

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Porto Alegre, , Brazil

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Recife, , Brazil

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Rio de Janeiro, , Brazil

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São Paulo, , Brazil

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São Paulo, , Brazil

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Edmonton, Alberta, Canada

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London, Ontario, Canada

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Greenfield Park, Quebec, Canada

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Zagreb, , Croatia

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Prague, Prague, Czechia

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Prague, Prague, Czechia

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Nový Jičín, , Czechia

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Aarhus, Central Jutland, Denmark

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Kolding, Southern Denmark, Denmark

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Tallinn, , Estonia

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Tartu, , Estonia

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Bordeaux, , France

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Clermont-Ferrand, , France

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Créteil, , France

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Grenoble, , France

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Marseille, , France

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Nice, , France

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Paris, , France

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Paris, , France

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Paris, , France

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Saint-Priest-en-Jarez, , France

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Toulouse, , France

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Valenciennes, , France

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Düsseldorf, Westfalen, Germany

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Aachen, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Hanover, , Germany

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Stuttgart, , Germany

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Villingen-Schwenningen, , Germany

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Hong Kong, , Hong Kong

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Lai Chi Kok, , Hong Kong

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Bari, , Italy

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Bergamo, , Italy

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Bologna, , Italy

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Florence, , Italy

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Genova, , Italy

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Germaneto, , Italy

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Lecco, , Italy

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Milan, , Italy

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Monza, , Italy

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Pavia, , Italy

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Roma, , Italy

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Verona, , Italy

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Auckland, , New Zealand

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Hamilton, , New Zealand

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Lodz, , Poland

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Olsztyn, , Poland

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Olsztyn, , Poland

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Piotrkow Trybunalski, , Poland

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Warsaw, , Poland

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Warsaw, , Poland

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Wroclaw, , Poland

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Amadora, , Portugal

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Carnaxide, , Portugal

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Lisbon, , Portugal

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Lisbon, , Portugal

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Loures, , Portugal

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Porto, , Portugal

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Setúbal, , Portugal

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Vila Nova de Gaia, , Portugal

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Busan, , South Korea

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Daejeon, , South Korea

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Gyeonggi-do, , South Korea

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Gyeonggi-do, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Palma de Mallorca, Balearic Islands, Spain

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Lugo, Burela, Spain

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Sagunto, Valencia, Spain

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Badalona, , Spain

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Barcelona, , Spain

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Barcelona, , Spain

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Barcelona, , Spain

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Barcelona, , Spain

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Ciudad Real, , Spain

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Córdoba, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Majadahonda, , Spain

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Málaga, , Spain

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Santiago de Compostela, , Spain

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Seville, , Spain

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Seville, , Spain

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Valencia, , Spain

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Valencia, , Spain

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Zaragoza, , Spain

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Carshalton, London, United Kingdom

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Whitechapel, London, United Kingdom

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Fulwood, Preston, United Kingdom

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Brighton, , United Kingdom

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Cambridge, , United Kingdom

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Cardiff, , United Kingdom

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Leicester, , United Kingdom

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London, , United Kingdom

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London, , United Kingdom

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Manchester, , United Kingdom

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Newcastle, , United Kingdom

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Reading, , United Kingdom

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Salford, , United Kingdom

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Swansea, , United Kingdom

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York, , United Kingdom

Countries

United States; Argentina; Australia; Belgium; Brazil; Canada; Croatia; Czechia; Denmark; Estonia; France; Germany; Hong Kong; Italy; New Zealand; Poland; Portugal; South Korea; Spain; Sweden; Taiwan; United Kingdom

References

Rheault MN. Treatment Approaches for Alport Syndrome. J Am Soc Nephrol. 2025 Sep 12. doi: 10.1681/ASN.0000000897. Online ahead of print.

Reference Type: DERIVED

PMID: 40938675 (View on PubMed)

Liu ID, Willis NS, Craig JC, Hodson EM. Interventions for idiopathic steroid-resistant nephrotic syndrome in children. Cochrane Database Syst Rev. 2025 May 8;5(5):CD003594. doi: 10.1002/14651858.CD003594.pub7.

Reference Type: DERIVED

PMID: 40337980 (View on PubMed)

Rheault MN, Alpers CE, Barratt J, Bieler S, Canetta P, Chae DW, Coppock G, Diva U, Gesualdo L, Heerspink HJL, Inrig JK, Kirsztajn GM, Kohan D, Komers R, Kooienga LA, Lieberman K, Mercer A, Noronha IL, Perkovic V, Radhakrishnan J, Rote W, Rovin B, Tesar V, Trimarchi H, Tumlin J, Wong MG, Trachtman H; DUPRO Steering Committee and DUPLEX Investigators. Sparsentan versus Irbesartan in Focal Segmental Glomerulosclerosis. N Engl J Med. 2023 Dec 28;389(26):2436-2445. doi: 10.1056/NEJMoa2308550. Epub 2023 Nov 3.

Reference Type: DERIVED

PMID: 37921461 (View on PubMed)

Obadina M, Wilson S, Derebail VK, Little J. Emerging Therapies and Advances in Sickle Cell Disease with a Focus on Renal Manifestations. Kidney360. 2023 Jul 1;4(7):997-1005. doi: 10.34067/KID.0000000000000162. Epub 2023 May 31.

Reference Type: DERIVED

PMID: 37254256 (View on PubMed)

Hodson EM, Sinha A, Cooper TE. Interventions for focal segmental glomerulosclerosis in adults. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD003233. doi: 10.1002/14651858.CD003233.pub3.

Reference Type: DERIVED

PMID: 35224732 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

http://travere.com

Corporate Website

Other Identifiers

021FSGS16010

Identifier Type: -

Identifier Source: org_study_id