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NCT03493685

PHASE3

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

Sponsor: Travere Therapeutics, Inc.

View on ClinicalTrials.gov

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).

Official title: A Randomized, Multicenter, Double-blind, Parallel, Active-control Study of the Effects of Sparsentan, a Dual Endothelin Receptor and Angiotensin Receptor Blocker, on Renal Outcomes in Patients With Primary FSGS

Key Details

Gender

All

Age Range

8 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

371

Start Date

2018-04-17

Completion Date

2026-03-19

Last Updated

2026-04-17

Healthy Volunteers

Conditions

Focal Segmental Glomerulosclerosis

Interventions

DRUG

sparsentan

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

DRUG

Irbesartan

target dose of 300 mg daily

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

Locations (226)

Travere Investigational Site

Mesa, Arizona, United States

Travere Investigational Site

Phoenix, Arizona, United States

Travere Investigational Site

Los Angeles, California, United States

Travere Investigational Site

Northridge, California, United States

Travere Investigational Site

Palo Alto, California, United States

Travere Investigational Site

San Diego, California, United States

Travere Investigational Site

San Dimas, California, United States

Travere Investigational Site

San Francisco, California, United States

Travere Investigational Site

Torrance, California, United States

Travere Investigational Site

Victorville, California, United States

Travere Investigational Site

Denver, Colorado, United States

Travere Investigational Site

Denver, Colorado, United States

Travere Investigational Site

Middlebury, Connecticut, United States

Travere Investigational Site

Wilmington, Delaware, United States

Travere Investigational Site

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

Travere Investigational Site

Coral Springs, Florida, United States

Travere Investigational Site

Fort Lauderdale, Florida, United States

Travere Investigational Site

Gainesville, Florida, United States

Travere Investigational Site

Miami, Florida, United States

Travere Investigational Site

Miami, Florida, United States

Travere Investigational Site

Miami, Florida, United States

Travere Investigational Site

Ocala, Florida, United States

Travere Investigational Site

Orlando, Florida, United States

Travere Investigational Site

Port Charlotte, Florida, United States

Travere Investigational Site

Temple Terrace, Florida, United States

Travere Investigational Site

Winter Park, Florida, United States

Travere Investigational Site

Lawrenceville, Georgia, United States

Travere Investigational Site

Nampa, Idaho, United States

Travere Investigational Site

Chicago, Illinois, United States

Travere Investigational Site

Hinsdale, Illinois, United States

Travere Investigational Site

Kansas City, Kansas, United States

Travere Investigational Site

Wichita, Kansas, United States

Travere Investigational Site

Louisville, Kentucky, United States

Travere Investigational Site

Monroe, Louisiana, United States

Travere Investigational Site

New Orleans, Louisiana, United States

Travere Investigational Site

Shreveport, Louisiana, United States

Travere Investigational Site

Boston, Massachusetts, United States

Travere Investigational Site

Springfield, Massachusetts, United States

Travere Investigational Site

Ann Arbor, Michigan, United States

Travere Investigational Site

Detroit, Michigan, United States

Travere Investigational Site

Minneapolis, Minnesota, United States

Travere Investigational Site

Minneapolis, Minnesota, United States

Travere Investigational Site

Rochester, Minnesota, United States

Travere Investigational Site

Kansas City, Missouri, United States

Travere Investigational Site

Kansas City, Missouri, United States

Travere Investigational Site

Las Vegas, Nevada, United States

Travere Investigational Site

Reno, Nevada, United States

Travere Investigational Site

Hackensack, New Jersey, United States

Travere Investigational Site

Fresh Meadows, New York, United States

Travere Investigational Site

New Hyde Park, New York, United States

Travere Investigational Site

New York, New York, United States

Travere Investigational Site

New York, New York, United States

Travere Investigational Site

New York, New York, United States

Travere Investigational Site

The Bronx, New York, United States

Travere Investigational Site

Chapel Hill, North Carolina, United States

Travere Investigational Site

Durham, North Carolina, United States

Travere Investigational Site

Raleigh, North Carolina, United States

Travere Investigational Site

Winston-Salem, North Carolina, United States

Travere Investigational Site

Cleveland, Ohio, United States

Travere Investigational Site

Columbus, Ohio, United States

Travere Investigational Site

Oklahoma City, Oklahoma, United States

Travere Investigational Site

Roseburg, Oregon, United States

Travere Investigational Site

Bethlehem, Pennsylvania, United States

Travere Investigational Site

Camp Hill, Pennsylvania, United States

Travere Investigational Site

Philadelphia, Pennsylvania, United States

Travere Investigational Site

Pittsburgh, Pennsylvania, United States

Travere Investigational Site

Upland, Pennsylvania, United States

Travere Investigational Site

Columbia, South Carolina, United States

Travere Investigational Site

Memphis, Tennessee, United States

Travere Investigational Site

Corpus Christi, Texas, United States

Travere Investigational Site

Dallas, Texas, United States

Travere Investigational Site

Dallas, Texas, United States

Travere Investigational Site

Dallas, Texas, United States

Travere Investigational Site

El Paso, Texas, United States

Travere Investigational Site

Fort Worth, Texas, United States

Travere Investigational Site

Houston, Texas, United States

Travere Investigational Site

Houston, Texas, United States

Travere Investigational Site

Lewisville, Texas, United States

Travere Investigational Site

Sherman, Texas, United States

Travere Investigational Site

Salt Lake City, Utah, United States

Travere Investigational Site

Salt Lake City, Utah, United States

Travere Investigational Site

St. George, Utah, United States

Travere Investigational Site

Hampton, Virginia, United States

Travere Investigational Site

Spokane, Washington, United States

Travere Investigational Site

Morgantown, West Virginia, United States

Travere Investigational Site

Marshfield, Wisconsin, United States

Travere Investigational Site

Wauwatosa, Wisconsin, United States

Travere Investigational Site

Buenos Aires, Argentina

Travere Investigational Site

Córdoba, Argentina

Travere Investigational Site

Córdoba, Argentina

Travere Investigational Site

Santa Fe, Argentina

Travere Investigational Site

Concord, New South Wales, Australia

Travere Investigational Site

New Lambton Heights, New South Wales, Australia

Travere Investigational Site

Saint Leonards, New South Wales, Australia

Travere Investigational Site

Wollongong, New South Wales, Australia

Travere Investigational Site

Birtinya, Queensland, Australia

Travere Investigational Site

Woolloongabba, Queensland, Australia

Travere Investigational Site

Adelaide, South Australia, Australia

Travere Investigational Site

Parkville, Victoria, Australia

Travere Investigational Site

Nedlands, Western Australia, Australia

And 126 more locations on ClinicalTrials.gov

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (226)