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NCT05003986 · ClinicalTrials.gov registry record · Phase 2

Study of Sparsentan Treatment in Pediatrics With Proteinuric Glomerular Diseases

A Phase 2 study of Focal Segmental Glomerulosclerosis and Immunoglobulin A Nephropathy, sponsored by Travere Therapeutics.

Recruiting
Registry status
Phase 2
Development phase
67
Enrollment target
20
Study locations

NCT05003986 is a Phase 2 study of Focal Segmental Glomerulosclerosis and Immunoglobulin A Nephropathy that is actively recruiting participants, run by Travere Therapeutics. The registered enrollment target is 67 participants, below the 233-participant average among 19 other Focal Segmental Glomerulosclerosis trials with a reported enrollment target (71% lower). The trial reports 20 study locations across 14 states.

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The verdict

NCT05003986, a Phase 2 study of Focal Segmental Glomerulosclerosis and Immunoglobulin A Nephropathy, is actively recruiting participants, sponsored by Travere Therapeutics.

RECRUITING
Registry status
Phase 2
Development phase
67 participants
Enrollment target
20
Study locations

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 Studied

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

Interventions

  • DRUG Sparsentan

Study Locations (20)

North Carolina

  • University of North Carolina at Chapel Hill - Chapel Hill
  • Atrium Health Levine Children's Hospital - Charlotte
  • Duke Molecular Physiology Institute - Durham

Florida

  • University of Miami, Leonard M. Miller School of Medicine - Miami
  • Nicklaus Children's Hospital - Miami

New Jersey

  • Hackensack University Medical Center - Hackensack
  • Jersey Shore University Medical Center - Neptune City

New York

  • Cohen Children's Medical Center - New Hyde Park
  • Fink Children's Ambulatory Care Center - New York

Pennsylvania

  • Children's Hospital of Philadelphia - Philadelphia
  • St. Christopher's Hospital for Children - Philadelphia

California

  • Cedars-Sinai Medical Center - Los Angeles

Delaware

  • Nemours Children's Hospital - Wilmington

Iowa

  • University of Iowa, Stead Family Children's Hospital - Iowa City

Trial Details

FieldValue
Enrollment Target 67 participants
Start Date 2021-08-12
Est. Completion 2027-04-12
Phase Phase 2

Sponsor

Travere Therapeutics

12 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05003986

The ClinicalTrials.gov registry entry for NCT05003986 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 67 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 233-participant average among 19 other Focal Segmental Glomerulosclerosis trials with a reported enrollment target (71% lower). The listed sponsor is Travere Therapeutics, which has 12 total studies on file at ClinicalTrials.gov.

The record links to 5 conditions, with Focal Segmental Glomerulosclerosis appearing as the primary indexed condition, and to 1 intervention - of which Sparsentan is the first listed.

NCT05003986 reports 20 study locations spanning 14 distinct geographic areas - top geographies include North Carolina, Florida, New Jersey.

Frequently Asked Questions

What is clinical trial NCT05003986 about?

NCT05003986 is a clinical study titled "Study of Sparsentan Treatment in Pediatrics With Proteinuric Glomerular Diseases". 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.

What is the current status of trial NCT05003986?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 67 participants. The study started on 2021-08-12. Estimated completion is 2027-04-12.

What conditions does trial NCT05003986 study?

This clinical trial studies the following conditions: Focal Segmental Glomerulosclerosis, Immunoglobulin A Nephropathy, Minimal Change Disease, IgA Vasculitis, Alport Syndrome.

What interventions are being tested in trial NCT05003986?

The interventions under investigation include: Sparsentan (DRUG).

Who is sponsoring clinical trial NCT05003986?

This trial is sponsored by Travere Therapeutics, which has 12 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05003986 being conducted?

This trial has 20 study locations across California, Delaware, Florida, Iowa, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.