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Study of Sparsentan Treatment in Pediatrics With Proteinuric Glomerular Diseases

NCT05003986 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2026-05-12

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Sparsentan

Population 1: 800 mg Sparsentan (oral suspension)

DRUG

Sparsentan

Population 2: 400 mg Sparsentan (oral suspension)

DRUG

Sparsentan

Population 3: 400 mg Sparsentan (tablets)

Sponsors & Collaborators

  • Travere Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-12
Primary Completion
2027-03-12
Completion
2027-04-12
FDA Drug
Yes

Countries

  • United States
  • Germany
  • Italy
  • Netherlands
  • Poland
  • Spain
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05003986 on ClinicalTrials.gov