RECRUITING

Study of Sparsentan Treatment in Pediatrics With Proteinuric Glomerular Diseases

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Conditions

Focal Segmental GlomerulosclerosisMinimal Change DiseaseImmunoglobulin A NephropathyIgA VasculitisAlport SyndromeAlport, AS, FSGS, IgAN, IgAV, MCD, pediatrics, peds

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 2, Open-Label, Single-Arm, Cohort Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Sparsentan Treatment in Pediatric Subjects With Selected Proteinuric Glomerular Diseases

Quick Facts

Study Start:2021-08-12
Study Completion:2025-06-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05003986

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:1 Year to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Travere Call Center
CONTACT
1-877-659-5518
medinfo@travere.com

Principal Investigator

Radko Komers, MD, PhD
STUDY_DIRECTOR
Travere Therapeutics, Inc.

Study Locations (Sites)

Travere Investigational Site
Los Angeles, California, 90048
United States
Travere Investigational Site
Wilmington, Delaware, 19803
United States
Travere Investigational Site
Miami, Florida, 33136
United States
Travere Investigational Site
Miami, Florida, 33155
United States
Travere Investigational Site
Iowa City, Iowa, 52242
United States
Travere Investigational Site
Boston, Massachusetts, 02111
United States
Travere Investigational Site
Ann Arbor, Michigan, 48109-5008
United States
Travere Investigational Site
Minneapolis, Minnesota, 55454
United States
Travere Investigational Site
Kansas City, Missouri, 64108
United States
Travere Investigational Site
Hackensack, New Jersey, 07601
United States
Travere Investigational Site
Neptune, New Jersey, 07753
United States
Travere Investigational Site
New Hyde Park, New York, 11042
United States
Travere Investigational Site
New York, New York, 10016
United States
Travere Investigational Site
Chapel Hill, North Carolina, 27599
United States
Travere Investigational Site
Charlotte, North Carolina, 28203
United States
Travere Investigational Site
Durham, North Carolina, 22710
United States
Travere Investigational Site
Columbus, Ohio, 43205
United States
Travere Investigational Site
Oklahoma City, Oklahoma, 73104
United States
Travere Investigational Site
Philadelphia, Pennsylvania, 19104
United States
Travere Investigational Site
Philadelphia, Pennsylvania, 19134
United States
Travere Investigational Site
Houston, Texas, 77030
United States
Travere Investigational Site
Seattle, Washington, 98105
United States

Collaborators and Investigators

Sponsor: Travere Therapeutics, Inc.

  • Radko Komers, MD, PhD, STUDY_DIRECTOR, Travere Therapeutics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-08-12
Study Completion Date2025-06-01

Study Record Updates

Study Start Date2021-08-12
Study Completion Date2025-06-01

Terms related to this study

Keywords Provided by Researchers

  • Alport, AS, FSGS, IgAN, IgAV, MCD, pediatrics, peds

Additional Relevant MeSH Terms

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