A Study to Investigate Safety and Effect of Sparsentan in Combination With SGLT2 Inhibition in Participants With IgAN

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Travere Therapeutics, Inc.
Study ID
NCT05856760
Phase
PHASE2
Status
Completed

Conditions

  • Immunoglobulin A Nephropathy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

This was a 28-week, open-label, multicenter, single-group Phase 2 exploratory study to determine the safety and effect of sparsentan in participants with IgAN who are at risk of disease progression to kidney failure despite being on both stable RAASi and SGLT2 inhibitor treatment for at least 12 weeks prior to study entry

Key Dates

First listed
May 12, 2023
Start date
May 19, 2023
Status verified
Sep 2025
Primary completion
Oct 14, 2024
Completion
Oct 25, 2024

Study Design

Enrollment
48 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: sparsentan
    Sparsentan will be administered daily as a 200-mg oral tablet. The goal is to titrate from the initial dose of 200 mg (Day 1) to the target dose of 400 mg at Week 2.

Primary Outcome Measure

Change in Urine Albumin-creatinine Ratio (UA/C) at Week 24 [ Time Frame: Week 24 ]

Locations (25)

FacilityCityStateZIPSite coordinators
Travere Investigational SiteBirminghamAlabama35233-
Travere Investigational SiteChula VistaCalifornia91910-
Travere Investigational SiteGarden GroveCalifornia92844-
Travere Investigational SiteGlendaleCalifornia91206-
Travere Investigational SiteDenverColorado80230-
Travere Investigational SiteBoiseIdaho83706-
Travere Investigational SiteChubbuckIdaho83202-
Travere Investigational SiteIdaho FallsIdaho83404-
Travere Investigational SiteChicagoIllinois60611-
Travere Investigational SiteEvergreen ParkIllinois60805-
Travere Investigational SiteFort WayneIndiana46804-
Travere Investigational SiteKansas CityKansas66160-
Travere Investigational SiteLouisvilleKentucky40205-
Travere Investigational SiteShreveportLouisiana71101-
Travere Investigational SiteAlbuquerqueNew Mexico87109-
Travere Investigation SiteClifton ParkNew York12065-
Travere Investigational SiteFresh MeadowsNew York11365-
Travere Investigational SiteNew YorkNew York10013-
Travere Investigational SiteJacksonvilleNorth Carolina28546-
Travere Investigational SiteNew BernNorth Carolina28562-
Travere Investigational SiteColumbusOhio43210-
Travere Investigational SitePhiladelphiaPennsylvania19104-
Travere Investigational SiteColumbiaSouth Carolina29203-
Travere Investigational SiteDallasTexas75230-
Travere Investigational SiteDallasTexas75246-

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Travere Investigational Site· Birmingham, ALTravere Investigational Site· Chula Vista, CATravere Investigational Site· Garden Grove, CATravere Investigational Site· Glendale, CATravere Investigational Site· Denver, COTravere Investigational Site· Boise, ID

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