Study of Sparsentan in Patients With Primary Focal Segmental Glomerulosclerosis (FSGS)
DUPLEX
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
1 other identifier
interventional
371
21 countries
206
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2018
Longer than P75 for phase_3
206 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 3, 2018
CompletedFirst Posted
Study publicly available on registry
April 10, 2018
CompletedStudy Start
First participant enrolled
April 17, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 20, 2023
CompletedResults Posted
Study results publicly available
April 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 19, 2026
CompletedApril 17, 2026
April 1, 2026
4.9 years
April 3, 2018
March 15, 2024
April 15, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Slope of Estimated Glomerular Filtration Rate (eGFR)
The total eGFR slope over 2 years, defined as the slope of eGFR following initiation of randomized treatment (ie, Day 1 to Week 108). Estimates are calculated from a mixed-effects model with treatment, Baseline eGFR, analysis visit, treatment-by-analysis visit, randomization stratification factors as fixed effects, and intercept and slope for each participant as a random effect.
From Day 1 to Week 108
Percentage of Participants Achieving FSGS Partial Remission Endpoint (FPRE)
Percentage of participants achieving FPRE, defined as urine protein-to-creatinine ratio (UP/C) ≤1.5 grams/gram (g/g) (170 milligrams per millimoles \[mg/mmol\]) and a \>40% reduction from Baseline was analyzed using a generalized linear model to model probability of achieving FPRE. Missing responses were imputed prior to analysis using multiple imputation. A generalized linear model with appropriate link function was implemented with Baseline log (UP/C), treatment, analysis visit, treatment by analysis visit interaction, and randomization strata as fixed effects. For estimates of probability of achieving FPRE, risk difference, and odds ratio, binomial distribution with logit link was used. For relative risk, Poisson distribution with log link was used. Using Rubin's approach, estimated treatment effects are combined across all imputations to obtain overall estimates for probabilities.
Week 36
Secondary Outcomes (2)
Slope of eGFR Following the Initial Acute Effect of Randomized Treatment
From Week 6 to Week 108
Change From Baseline in eGFR to 4 Weeks Post-cessation of Randomized Treatment
Baseline (Day 1) to Week 112
Study Arms (2)
sparsentan for double-blind and open-label extension
EXPERIMENTALSparsentan 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
Irbesartan
ACTIVE COMPARATORIrbesartan 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
Interventions
Double-blind period: target dose of 800 mg daily; Open-label extension: target dose based on dosage from week 114 daily
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
- Complete participation in the double-blind period, including the Week 112 visit.
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (226)
Travere Investigational Site
Mesa, Arizona, 85210, United States
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Phoenix, Arizona, 85027, United States
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Los Angeles, California, 90048, United States
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Northridge, California, 91324, United States
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Palo Alto, California, 94304, United States
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San Diego, California, 92103, United States
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San Dimas, California, 91773, United States
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San Francisco, California, 94118, United States
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Torrance, California, 90502, United States
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Victorville, California, 92395, United States
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Denver, Colorado, 80205, United States
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Denver, Colorado, 80230, United States
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Middlebury, Connecticut, 06762, United States
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Wilmington, Delaware, 19803, United States
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Washington D.C., District of Columbia, 20010, United States
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Coral Springs, Florida, 33071, United States
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Fort Lauderdale, Florida, 33308, United States
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Gainesville, Florida, 32610, United States
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Miami, Florida, 33126, United States
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Miami, Florida, 33136, United States
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Miami, Florida, 33155, United States
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Ocala, Florida, 34471, United States
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Orlando, Florida, 32827, United States
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Port Charlotte, Florida, 33952, United States
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Temple Terrace, Florida, 33637, United States
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Winter Park, Florida, 32789, United States
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Lawrenceville, Georgia, 30046, United States
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Nampa, Idaho, 86387, United States
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Chicago, Illinois, 60611, United States
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Hinsdale, Illinois, 60521, United States
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Kansas City, Kansas, 66160, United States
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Wichita, Kansas, 67214, United States
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Louisville, Kentucky, 40202, United States
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Monroe, Louisiana, 71201, United States
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New Orleans, Louisiana, 70121, United States
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Shreveport, Louisiana, 71101, United States
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Boston, Massachusetts, 02111, United States
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Springfield, Massachusetts, 01107, United States
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Ann Arbor, Michigan, 48109, United States
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Detroit, Michigan, 48202, United States
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Minneapolis, Minnesota, 55404, United States
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Minneapolis, Minnesota, 55455, United States
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Rochester, Minnesota, 55902, United States
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Kansas City, Missouri, 64108, United States
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Kansas City, Missouri, 64111, United States
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Las Vegas, Nevada, 89129, United States
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Reno, Nevada, 89511, United States
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Hackensack, New Jersey, 07601, United States
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Fresh Meadows, New York, 11365, United States
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New Hyde Park, New York, 11040, United States
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New York, New York, 10016, United States
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New York, New York, 10029, United States
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New York, New York, 10032, United States
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The Bronx, New York, 10467, United States
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Chapel Hill, North Carolina, 27514, United States
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Durham, North Carolina, 27710, United States
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Raleigh, North Carolina, 27609, United States
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Winston-Salem, North Carolina, 27103, United States
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Cleveland, Ohio, 44195, United States
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Columbus, Ohio, 43210, United States
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Oklahoma City, Oklahoma, 73104, United States
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Roseburg, Oregon, 97471, United States
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Bethlehem, Pennsylvania, 18017, United States
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Camp Hill, Pennsylvania, 17011, United States
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Philadelphia, Pennsylvania, 19104, United States
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Pittsburgh, Pennsylvania, 15224, United States
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Upland, Pennsylvania, 19013, United States
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Columbia, South Carolina, 29203, United States
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Memphis, Tennessee, 38103, United States
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Corpus Christi, Texas, 78412, United States
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Dallas, Texas, 75231, United States
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Dallas, Texas, 75235, United States
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Dallas, Texas, 75246, United States
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El Paso, Texas, 79902, United States
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Fort Worth, Texas, 76104, United States
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Houston, Texas, 77030, United States
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Houston, Texas, 77054, United States
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Lewisville, Texas, 75057, United States
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Sherman, Texas, 75090, United States
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Salt Lake City, Utah, 84112, United States
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Salt Lake City, Utah, 84115, United States
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St. George, Utah, 84790, United States
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Hampton, Virginia, 23666, United States
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Spokane, Washington, 99204, United States
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Morgantown, West Virginia, 26506, United States
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Marshfield, Wisconsin, 54449, United States
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Wauwatosa, Wisconsin, 53226, United States
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Buenos Aires, C1280AEB, Argentina
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Córdoba, X5000JHGQ, Argentina
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Córdoba, X5016LIG, Argentina
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Santa Fe, S3000, Argentina
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Concord, New South Wales, 2139, Australia
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New Lambton Heights, New South Wales, 2305, Australia
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Saint Leonards, New South Wales, 2065, Australia
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Wollongong, New South Wales, 2522, Australia
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Birtinya, Queensland, 4575, Australia
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Woolloongabba, Queensland, 4102, Australia
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Adelaide, South Australia, 5000, Australia
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Parkville, Victoria, 3050, Australia
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Nedlands, Western Australia, 6009, Australia
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Leuven, 3000, Belgium
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Liège, 4000, Belgium
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Roeselare, 8800, Belgium
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Botucatu, 18618-686, Brazil
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Itaquera, 08270-120, Brazil
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Passo Fundo, 99010-080, Brazil
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Porto Alegre, 90035-903, Brazil
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Recife, 50670-901, Brazil
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Rio de Janeiro, 20551-030, Brazil
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São Paulo, 04038-002, Brazil
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São Paulo, 05403-000, Brazil
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Edmonton, Alberta, T6G 2B7, Canada
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London, Ontario, N6A 5A5, Canada
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Greenfield Park, Quebec, J4V 2H1, Canada
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Zagreb, 10000, Croatia
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Prague, Prague, 100 34, Czechia
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Prague, Prague, 120 00, Czechia
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Nový Jičín, 74101, Czechia
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Aarhus, Central Jutland, 8200, Denmark
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Kolding, Southern Denmark, 6000, Denmark
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Tallinn, 10617, Estonia
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Tartu, 50406, Estonia
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Bordeaux, 33076, France
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Clermont-Ferrand, 63003, France
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Créteil, 94000, France
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Grenoble, 38043, France
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Marseille, 13005, France
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Nice, 06001, France
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Paris, 75010, France
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Paris, 75015, France
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Paris, 75743, France
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Saint-Priest-en-Jarez, 42270, France
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Toulouse, 31059, France
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Valenciennes, 59322, France
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Düsseldorf, Westfalen, 40210, Germany
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Aachen, 52074, Germany
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Berlin, 10117, Germany
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Berlin, 12203, Germany
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Hanover, 30625, Germany
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Stuttgart, 70376, Germany
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Villingen-Schwenningen, 78052, Germany
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Hong Kong, Hong Kong
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Lai Chi Kok, Hong Kong
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Bari, 70124, Italy
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Bergamo, 24127, Italy
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Bologna, 40138, Italy
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Florence, 50134, Italy
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Genova, 16132, Italy
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Germaneto, 88100, Italy
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Lecco, 23900, Italy
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Milan, 20122, Italy
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Monza, 20900, Italy
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Pavia, 27100, Italy
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Roma, 168, Italy
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Verona, 37126, Italy
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Auckland, 1051, New Zealand
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Hamilton, 3204, New Zealand
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Lodz, 93-347, Poland
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Olsztyn, 10-117, Poland
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Olsztyn, 10-561, Poland
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Piotrkow Trybunalski, 97-300, Poland
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Warsaw, 00-631, Poland
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Warsaw, 04-749, Poland
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Wroclaw, 50-556, Poland
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Amadora, 2720-276, Portugal
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Carnaxide, 2790-134, Portugal
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Lisbon, 1050-099, Portugal
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Lisbon, 1649-035, Portugal
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Loures, 2674-514, Portugal
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Porto, 4200-319, Portugal
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Setúbal, 2910-446, Portugal
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Vila Nova de Gaia, 4434-502, Portugal
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Busan, 47392, South Korea
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Daejeon, 35015, South Korea
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Gyeonggi-do, 13620, South Korea
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Gyeonggi-do, 14068, South Korea
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Seoul, 3080, South Korea
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Seoul, 3722, South Korea
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Palma de Mallorca, Balearic Islands, 07120, Spain
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Lugo, Burela, 27880, Spain
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Sagunto, Valencia, 46520, Spain
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Badalona, 8916, Spain
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Barcelona, 08003, Spain
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Barcelona, 08025, Spain
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Barcelona, 08035, Spain
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Barcelona, 08036, Spain
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Ciudad Real, 13005, Spain
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Córdoba, 14004, Spain
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Madrid, 28040, Spain
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Madrid, 28041, Spain
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Majadahonda, 28222, Spain
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Málaga, 29010, Spain
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Santiago de Compostela, 15706, Spain
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Seville, 41009, Spain
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Seville, 41013, Spain
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Valencia, 46014, Spain
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Valencia, 46017, Spain
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Zaragoza, 50009, Spain
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Solna, SE-171 64, Sweden
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Uppsala, 75237, Sweden
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Uppsala, SE-751 85, Sweden
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Hualien City, 970, Taiwan
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Kaohsiung City, 81362, Taiwan
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New Taipei City, 235, Taiwan
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Taichung, 404, Taiwan
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Taichung, 40705, Taiwan
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Tainan, 710, Taiwan
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Taipei, 10048, Taiwan
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Taipei, 104, Taiwan
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Taipei, 110, Taiwan
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Taoyuan District, 333, Taiwan
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Carshalton, London, SM5 1AA, United Kingdom
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Whitechapel, London, E1 1BB, United Kingdom
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Fulwood, Preston, PR2 9HT, United Kingdom
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Brighton, BN2 5BE, United Kingdom
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Cambridge, CB2 0QQ, United Kingdom
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Cardiff, CF14 4XW, United Kingdom
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Leicester, LE5 4PW, United Kingdom
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London, NW3 2QG, United Kingdom
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London, SE5 9RS, United Kingdom
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Manchester, M13 9WL, United Kingdom
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Newcastle, NE7 7DN, United Kingdom
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Reading, RG1 5AN, United Kingdom
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Salford, M6 8HD, United Kingdom
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Swansea, SA6 6NL, United Kingdom
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York, YO31 8HE, United Kingdom
Related Publications (6)
Yee J, Gong W, Inrig J, Rheault MN, Gruber AJ, Bedard PW, Komers R, Trachtman H. Antiproteinuric Effect of Sparsentan in Patients with Genetic-Associated FSGS Enrolled in the DUPLEX Trial. Clin J Am Soc Nephrol. 2025 Dec 23. doi: 10.2215/CJN.0000000948. Online ahead of print. No abstract available.
PMID: 41433094DERIVEDRheault MN. Treatment Approaches for Alport Syndrome. J Am Soc Nephrol. 2026 Jan 1;37(1):172-179. doi: 10.1681/ASN.0000000897. Epub 2025 Sep 12.
PMID: 40938675DERIVEDLiu 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.
PMID: 40337980DERIVEDRheault 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.
PMID: 37921461DERIVEDObadina 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.
PMID: 37254256DERIVEDHodson 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.
PMID: 35224732DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Travere Therapeutics Call Center
- Organization
- Travere Therapeutics, Inc
Study Officials
- STUDY DIRECTOR
Radko Komers, MD, PhD
Travere Therapeutics, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 3, 2018
First Posted
April 10, 2018
Study Start
April 17, 2018
Primary Completion
March 20, 2023
Study Completion
March 19, 2026
Last Updated
April 17, 2026
Results First Posted
April 30, 2024
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Requests can be made following completion of the study and full publication of the study data in a peer reviewed journal for up to 36 months following its publication.
- Access Criteria
- Requires submission and approval of intended use and a data sharing agreement.
Requests for clinical trial data, including language stating its intended use, should be directed to datarequest@travere.com. If approved, the requested information will be provided to the requestor after signing a data access agreement. Requests can be made following completion of the study and full publication of the study data in a peer reviewed journal for up to 36 months following its publication. Travere reserves the right to decline or recommend modifications to a request if it does not comply with the data sharing policy or if it is determined that the request is made by a biased source.