Actively Recruiting
Study of Sparsentan Treatment in Pediatrics With Proteinuric Glomerular Diseases
Led by Travere Therapeutics, Inc. · Updated on 2026-05-12
67
Participants Needed
47
Research Sites
295 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Study of Sparsentan Treatment in Pediatrics With Proteinuric Glomerular Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- The child or parent/legal guardian is willing and able to provide signed informed consent/assent as required before screening.
- The child has an estimated glomerular filtration rate (eGFR) of 30 mL/min/1.73 m2 or higher at screening.
- The child's mean seated blood pressure is between the 5th and 95th percentile for their sex and height.
- Population 1: Child is aged 1 to under 18 years with UP/C of 1.5 g/g or higher and has kidney biopsy-proven FSGS or MCD or a documented genetic mutation related to these diseases.
- Population 2: Child is aged 2 to under 18 years with UP/C of 0.6 g/g or higher and has kidney biopsy-confirmed IgAN, IgAV, or AS, or genetic confirmation of Alport Syndrome.
- Population 3: Child is aged 8 to under 18 years with UP/C of 1.0 g/g or higher, kidney biopsy-confirmed IgAN, weighs 40 kg or more, and has been on ACEI and/or ARB therapy for at least 12 weeks before screening.
You will not qualify if you...
- The child weighs less than 7.3 kg at screening.
- FSGS or MCD caused by viral infections, drug toxicities, or malignancies.
- IgA deposits not related to primary IgAN or IgAV (such as those caused by lupus or liver disease).
- Acute onset or relapse of glomerular disease requiring new immunosuppressive treatment within 6 months before screening.
- Unstable use of chronic immunosuppressive medications including systemic steroids within 1 month before screening.
- Use of prohibited medications as defined in the study protocol.
- History of organ transplantation except corneal transplants.
- History of moderate to severe heart failure or related hospitalizations.
- Significant cardiac valvular or congenital vascular disease.
- Jaundice, hepatitis, hepatobiliary disease, or liver enzyme levels more than twice the upper normal limit.
- History of malignancy within the past 2 years.
- Low hematocrit (<27%) or hemoglobin (<9 g/dL) at screening.
- High potassium levels (>5.5 mEq/L) at screening.
- Any clinically significant abnormal laboratory results.
- Allergy or hypersensitivity to sparsentan or its ingredients.
- Pregnancy, breastfeeding, or unwillingness to use reliable contraception if of childbearing potential.
- Participation in another investigational drug study within 28 days before screening.
- Prior exposure to sparsentan.
- Inability to comply with study requirements or, for Population 3, inability to swallow tablets whole.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 47 locations
1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
2
Nemours Children's Hospital
Wilmington, Delaware, United States, 19803
Actively Recruiting
3
University of Miami, Leonard M. Miller School of Medicine
Miami, Florida, United States, 33136
Actively Recruiting
4
Nicklaus Children's Hospital
Miami, Florida, United States, 33155
Actively Recruiting
5
University of Iowa, Stead Family Children's Hospital
Iowa City, Iowa, United States, 52242
Withdrawn
6
Floating Hospital for Children at Tufts Medical Center
Boston, Massachusetts, United States, 02111
Withdrawn
7
C.S. Mott Children's Hospital
Ann Arbor, Michigan, United States, 48109-5008
Actively Recruiting
8
University of Minnesota, Masonic Children's Hospital
Minneapolis, Minnesota, United States, 55454
Actively Recruiting
9
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, United States, 64108
Actively Recruiting
10
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Actively Recruiting
11
Jersey Shore University Medical Center
Neptune City, New Jersey, United States, 07753
Actively Recruiting
12
Cohen Children's Medical Center
New Hyde Park, New York, United States, 11042
Actively Recruiting
13
Fink Children's Ambulatory Care Center
New York, New York, United States, 10016
Withdrawn
14
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
15
Atrium Health Levine Children's Hospital
Charlotte, North Carolina, United States, 28203
Completed
16
Duke Molecular Physiology Institute
Durham, North Carolina, United States, 22710
Actively Recruiting
17
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Actively Recruiting
18
University of Oklahoma Health Sciences Center (OUHSC)
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
19
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
20
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, United States, 19134
Withdrawn
21
Texas Children's Hospital
Houston, Texas, United States, 77030
Actively Recruiting
22
UT Health - John P. and Kathrine G. McGovern Medical School
Houston, Texas, United States, 77030
Withdrawn
23
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Actively Recruiting
24
Uniklinik Köln, Klinik und Poliklinik für Kinder- und Jugendmedizin
Cologne, Germany, 50937
Actively Recruiting
25
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany, 20246
Actively Recruiting
26
Universitätsklinikum Heidelberg - Angelika Lautenschläger - Kinderklinik
Heidelberg, Germany, 69120
Actively Recruiting
27
Policlinico Bari Ospedale Pediatrico Giovanni XXIII
Bari, Italy, 70126
Actively Recruiting
28
IRCCS Istituto Giannina Gaslini
Genova, Italy, 16147
Actively Recruiting
29
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Italy, 20122
Actively Recruiting
30
Azienda Ospedale Università di Padova
Padova, Italy, 35128
Actively Recruiting
31
Ospedale Pediatrico Bambino Gesù
Roma, Italy, 00165
Actively Recruiting
32
Emma Kinderziekenhuis
Amsterdam, Netherlands, 1105 AZ
Actively Recruiting
33
Radboud Universitair Medisch Centrum
Nijmegen, Netherlands, 6525 GA
Withdrawn
34
Uniwersytecki Szpital Dziecięcy w Krakowie
Krakow, Poland, 30-663
Actively Recruiting
35
Instytut Centrum Zdrowia Matki Polki
Lodz, Poland, 93-338
Withdrawn
36
Instytut Pomnik - Centrum Zdrowia Dziecka
Warsaw, Poland, 04-730
Withdrawn
37
Hospital Universitari Vall d'Hebrón
Barcelona, Spain, 08035
Actively Recruiting
38
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
39
Hospital Universitario La Paz
Madrid, Spain, 28046
Actively Recruiting
40
Hospital Universitario Virgen del Rocío
Seville, Spain, 41013
Actively Recruiting
41
Drottning Silvias Barn- och Ungdomssjukhus
Gothenburg, Sweden, 416 85
Actively Recruiting
42
Karolinska Universitetssjukhuset Huddinge
Stockholm, Sweden, 141 86
Actively Recruiting
43
University Hospitals Bristol and Weston NHS Foundation Trust, Bristol Royal Hospital for Children
Bristol, United Kingdom, BS2 8BJ
Actively Recruiting
44
NHS Greater Glasgow and Clyde, Royal Hospital for Children
Glasgow, United Kingdom, G51 4TF
Actively Recruiting
45
Alder Hey Children's NHS Foundation Trust
Liverpool, United Kingdom, L12 2AP
Actively Recruiting
46
Great Ormond Street Hospital for Children NHS Foundation Trust
London, United Kingdom, WC1N3JH
Actively Recruiting
47
Manchester University NHS Foundation Trust
Manchester, United Kingdom, M13 9WL
Actively Recruiting
Research Team
T
Travere Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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