RecruitingPhase 2NCT05003986

Study of Sparsentan Treatment in Pediatrics With Proteinuric Glomerular Diseases

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

Sponsor

Travere Therapeutics, Inc.

Enrollment

67 participants

Start Date

Aug 12, 2021

Study Type

INTERVENTIONAL

Conditions

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

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.

Eligibility

Min Age: 1 YearMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called sparsentan in children with proteinuric glomerular diseases — kidney conditions that cause abnormal amounts of protein to leak into the urine. This includes diseases like FSGS, IgA nephropathy, Alport Syndrome, and MCD. Researchers want to see if sparsentan can reduce protein in the urine and protect kidney function. You may be eligible if: - You are a child between 1 and 17 years old (age range depends on the specific kidney disease) - You have a confirmed diagnosis of FSGS, MCD, IgA nephropathy, Alport Syndrome, or IgA vasculitis - Your kidney function (eGFR) is at or above 30 mL/min/1.73 m² - Your blood pressure is within normal range for your age and height - You have elevated protein in your urine meeting study thresholds You may NOT be eligible if: - You weigh less than 7.3 kg - You have received an organ transplant (except corneal) - You have significant heart failure or serious heart conditions - You have liver disease or recent malignancy - You are pregnant or breastfeeding - You have had an acute flare or recent change in immunosuppressive treatment within 6 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSparsentan

Population 1: 800 mg Sparsentan (oral suspension)

DRUGSparsentan

Population 2: 400 mg Sparsentan (oral suspension)

DRUGSparsentan

Population 3: 400 mg Sparsentan (tablets)

Locations(47)

Cedars-Sinai Medical Center

Los Angeles, California, United States

Nemours Children's Hospital

Wilmington, Delaware, United States

University of Miami, Leonard M. Miller School of Medicine

Miami, Florida, United States

Nicklaus Children's Hospital

Miami, Florida, United States

University of Iowa, Stead Family Children's Hospital

Iowa City, Iowa, United States

Floating Hospital for Children at Tufts Medical Center

Boston, Massachusetts, United States

C.S. Mott Children's Hospital

Ann Arbor, Michigan, United States

University of Minnesota, Masonic Children's Hospital

Minneapolis, Minnesota, United States

Children's Mercy Hospitals and Clinics

Kansas City, Missouri, United States

Hackensack University Medical Center

Hackensack, New Jersey, United States

Jersey Shore University Medical Center

Neptune City, New Jersey, United States

Cohen Children's Medical Center

New Hyde Park, New York, United States

Fink Children's Ambulatory Care Center

New York, New York, United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Atrium Health Levine Children's Hospital

Charlotte, North Carolina, United States

Duke Molecular Physiology Institute

Durham, North Carolina, United States

Nationwide Children's Hospital

Columbus, Ohio, United States

University of Oklahoma Health Sciences Center (OUHSC)

Oklahoma City, Oklahoma, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

St. Christopher's Hospital for Children

Philadelphia, Pennsylvania, United States

Texas Children's Hospital

Houston, Texas, United States

UT Health - John P. and Kathrine G. McGovern Medical School

Houston, Texas, United States

Seattle Children's Hospital

Seattle, Washington, United States

Uniklinik Köln, Klinik und Poliklinik für Kinder- und Jugendmedizin

Cologne, Germany

Universitätsklinikum Hamburg-Eppendorf

Hamburg, Germany

Universitätsklinikum Heidelberg - Angelika Lautenschläger - Kinderklinik

Heidelberg, Germany

Policlinico Bari Ospedale Pediatrico Giovanni XXIII

Bari, Italy

IRCCS Istituto Giannina Gaslini

Genova, Italy

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, Italy

Azienda Ospedale Università di Padova

Padova, Italy

Ospedale Pediatrico Bambino Gesù

Roma, Italy

Emma Kinderziekenhuis

Amsterdam, Netherlands

Radboud Universitair Medisch Centrum

Nijmegen, Netherlands

Uniwersytecki Szpital Dziecięcy w Krakowie

Krakow, Poland

Instytut Centrum Zdrowia Matki Polki

Lodz, Poland

Instytut Pomnik - Centrum Zdrowia Dziecka

Warsaw, Poland

Hospital Universitari Vall d'Hebrón

Barcelona, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital Universitario La Paz

Madrid, Spain

Hospital Universitario Virgen del Rocío

Seville, Spain

Drottning Silvias Barn- och Ungdomssjukhus

Gothenburg, Sweden

Karolinska Universitetssjukhuset Huddinge

Stockholm, Sweden

University Hospitals Bristol and Weston NHS Foundation Trust, Bristol Royal Hospital for Children

Bristol, United Kingdom

NHS Greater Glasgow and Clyde, Royal Hospital for Children

Glasgow, United Kingdom

Alder Hey Children's NHS Foundation Trust

Liverpool, United Kingdom

Great Ormond Street Hospital for Children NHS Foundation Trust

London, United Kingdom

Manchester University NHS Foundation Trust

Manchester, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT05003986

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