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

Part of paid clinical trials in Mesa, Arizona.

Sponsor
Travere Therapeutics, Inc.
Study ID
NCT03493685
Phase
PHASE3
Status
Completed

Conditions

  • Focal Segmental Glomerulosclerosis

Eligibility Criteria

Sex
ALL
Age
8 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • sparsentan — DRUG
    Double-blind period: target dose of 800 mg daily; Open-label extension: target dose based on dosage from week 114 daily
  • Irbesartan — DRUG
    target dose of 300 mg daily

Study Details

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).

Key Dates

Start date
Apr 17, 2018
Status verified
Apr 2026
Primary completion
Mar 20, 2023
Completion
Mar 19, 2026

Study Design

Enrollment
371 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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
  • Active Comparator: 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

Primary Outcome Measure

Slope of Estimated Glomerular Filtration Rate (eGFR) [ Time Frame: From Day 1 to Week 108 ]

Locations (87)

FacilityCityStateZIPSite coordinators
Travere Investigational SiteMesaArizona85210-
Travere Investigational SitePhoenixArizona85027-
Travere Investigational SiteLos AngelesCalifornia90048-
Travere Investigational SiteNorthridgeCalifornia91324-
Travere Investigational SitePalo AltoCalifornia94304-
Travere Investigational SiteSan DiegoCalifornia92103-
Travere Investigational SiteSan DimasCalifornia91773-
Travere Investigational SiteSan FranciscoCalifornia94118-
Travere Investigational SiteTorranceCalifornia90502-
Travere Investigational SiteVictorvilleCalifornia92395-
Travere Investigational SiteDenverColorado80205-
Travere Investigational SiteDenverColorado80230-
Travere Investigational SiteMiddleburyConnecticut06762-
Travere Investigational SiteWilmingtonDelaware19803-
Travere Investigational SiteWashington D.C.District of Columbia20010-
Travere Investigational SiteCoral SpringsFlorida33071-
Travere Investigational SiteFort LauderdaleFlorida33308-
Travere Investigational SiteGainesvilleFlorida32610-
Travere Investigational SiteMiamiFlorida33126-
Travere Investigational SiteMiamiFlorida33136-
Travere Investigational SiteMiamiFlorida33155-
Travere Investigational SiteOcalaFlorida34471-
Travere Investigational SiteOrlandoFlorida32827-
Travere Investigational SitePort CharlotteFlorida33952-
Travere Investigational SiteTemple TerraceFlorida33637-
Travere Investigational SiteWinter ParkFlorida32789-
Travere Investigational SiteLawrencevilleGeorgia30046-
Travere Investigational SiteNampaIdaho86387-
Travere Investigational SiteChicagoIllinois60611-
Travere Investigational SiteHinsdaleIllinois60521-
Travere Investigational SiteKansas CityKansas66160-
Travere Investigational SiteWichitaKansas67214-
Travere Investigational SiteLouisvilleKentucky40202-
Travere Investigational SiteMonroeLouisiana71201-
Travere Investigational SiteNew OrleansLouisiana70121-
Travere Investigational SiteShreveportLouisiana71101-
Travere Investigational SiteBostonMassachusetts02111-
Travere Investigational SiteSpringfieldMassachusetts01107-
Travere Investigational SiteAnn ArborMichigan48109-
Travere Investigational SiteDetroitMichigan48202-
Travere Investigational SiteMinneapolisMinnesota55404-
Travere Investigational SiteMinneapolisMinnesota55455-
Travere Investigational SiteRochesterMinnesota55902-
Travere Investigational SiteKansas CityMissouri64108-
Travere Investigational SiteKansas CityMissouri64111-
Travere Investigational SiteLas VegasNevada89129-
Travere Investigational SiteRenoNevada89511-
Travere Investigational SiteHackensackNew Jersey07601-
Travere Investigational SiteFresh MeadowsNew York11365-
Travere Investigational SiteNew Hyde ParkNew York11040-
Travere Investigational SiteNew YorkNew York10016-
Travere Investigational SiteNew YorkNew York10029-
Travere Investigational SiteNew YorkNew York10032-
Travere Investigational SiteThe BronxNew York10467-
Travere Investigational SiteChapel HillNorth Carolina27514-
Travere Investigational SiteDurhamNorth Carolina27710-
Travere Investigational SiteRaleighNorth Carolina27609-
Travere Investigational SiteWinston-SalemNorth Carolina27103-
Travere Investigational SiteClevelandOhio44195-
Travere Investigational SiteColumbusOhio43210-
Travere Investigational SiteOklahoma CityOklahoma73104-
Travere Investigational SiteRoseburgOregon97471-
Travere Investigational SiteBethlehemPennsylvania18017-
Travere Investigational SiteCamp HillPennsylvania17011-
Travere Investigational SitePhiladelphiaPennsylvania19104-
Travere Investigational SitePittsburghPennsylvania15224-
Travere Investigational SiteUplandPennsylvania19013-
Travere Investigational SiteColumbiaSouth Carolina29203-
Travere Investigational SiteMemphisTennessee38103-
Travere Investigational SiteCorpus ChristiTexas78412-
Travere Investigational SiteDallasTexas75231-
Travere Investigational SiteDallasTexas75235-
Travere Investigational SiteDallasTexas75246-
Travere Investigational SiteEl PasoTexas79902-
Travere Investigational SiteFort WorthTexas76104-
Travere Investigational SiteHoustonTexas77030-
Travere Investigational SiteHoustonTexas77054-
Travere Investigational SiteLewisvilleTexas75057-
Travere Investigational SiteShermanTexas75090-
Travere Investigational SiteSalt Lake CityUtah84112-
Travere Investigational SiteSalt Lake CityUtah84115-
Travere Investigational SiteSt. GeorgeUtah84790-
Travere Investigational SiteHamptonVirginia23666-
Travere Investigational SiteSpokaneWashington99204-
Travere Investigational SiteMorgantownWest Virginia26506-
Travere Investigational SiteMarshfieldWisconsin54449-
Travere Investigational SiteWauwatosaWisconsin53226-

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