Study of Sparsentan Treatment in Pediatrics With Proteinuric Glomerular Diseases

Part of paid clinical trials in Los Angeles, California.

Sponsor
Travere Therapeutics, Inc.
Study ID
NCT05003986
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Alport Syndrome
  • Focal Segmental Glomerulosclerosis
  • IgA Vasculitis
  • Immunoglobulin A Nephropathy
  • Minimal Change Disease

Eligibility Criteria

Sex
ALL
Age
1 Year - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Sparsentan — DRUG
    Population 1: 800 mg Sparsentan (oral suspension)
  • Sparsentan — DRUG
    Population 2: 400 mg Sparsentan (oral suspension)
  • Sparsentan — DRUG
    Population 3: 400 mg Sparsentan (tablets)

Study Details

To evaluate the safety, efficacy and tolerability of sparsentan oral suspension and tablets, and assess changes in proteinuria after once-daily dosing over 108 weeks.

Key Dates

Start date
Aug 12, 2021
Status verified
May 2026
Primary completion
Mar 12, 2027
Completion
Apr 12, 2027

Study Design

Enrollment
67 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Population 1: FSGS and/or MCD
    Subjects with selected proteinuric glomerular diseases associated with FSGS and MCD histological patterns
  • Experimental: Population 2: IgAN, IgAV, or AS
    Subjects with kidney biopsy-confirmed immunoglobulin A nephropathy (IgAN), immunoglobulin A vasculitis (IgAV), or Alport syndrome (AS)
  • Experimental: Population 3: IgAN
    Subjects with kidney biopsy-confirmed IgAN

Primary Outcome Measure

Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), AEs leading to treatment discontinuation, and adverse events of interest (AEOIs) [ Time Frame: After the last patient has undergone the week 108 visit (Visit 15). ]

Central Contacts

Locations (23)

FacilityCityStateZIPSite coordinators
Cedars-Sinai Medical CenterLos AngelesCalifornia90048-
Nemours Children's HospitalWilmingtonDelaware19803-
Nicklaus Children's HospitalMiamiFlorida33155-
University of Miami, Leonard M. Miller School of MedicineMiamiFlorida33136-
University of Iowa, Stead Family Children's HospitalIowa CityIowa52242-
Floating Hospital for Children at Tufts Medical CenterBostonMassachusetts02111-
C.S. Mott Children's HospitalAnn ArborMichigan48109-5008-
University of Minnesota, Masonic Children's HospitalMinneapolisMinnesota55454-
Children's Mercy Hospitals and ClinicsKansas CityMissouri64108-
Hackensack University Medical CenterHackensackNew Jersey07601-
Jersey Shore University Medical CenterNeptune CityNew Jersey07753-
Cohen Children's Medical CenterNew Hyde ParkNew York11042-
Fink Children's Ambulatory Care CenterNew YorkNew York10016-
University of North Carolina at Chapel HillChapel HillNorth Carolina27599-
Atrium Health Levine Children's HospitalCharlotteNorth Carolina28203-
Duke Molecular Physiology InstituteDurhamNorth Carolina22710-
Nationwide Children's HospitalColumbusOhio43205-
University of Oklahoma Health Sciences Center (OUHSC)Oklahoma CityOklahoma73104-
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104-
St. Christopher's Hospital for ChildrenPhiladelphiaPennsylvania19134-
Texas Children's HospitalHoustonTexas77030-
UT Health - John P. and Kathrine G. McGovern Medical SchoolHoustonTexas77030-
Seattle Children's HospitalSeattleWashington98105-

Find similar trials in Los Angeles, CA

By research site
Cedars-Sinai Medical Center· Los Angeles, CANemours Children's Hospital· Wilmington, DENicklaus Children's Hospital· Miami, FLUniversity of Miami, Leonard M. Miller School of Medicine· Miami, FLUniversity of Iowa, Stead Family Children's Hospital· Iowa City, IAFloating Hospital for Children at Tufts Medical Center· Boston, MA

Related Studies