Focal Segmental Glomerulosclerosis study: Sparsentan
Official title Study of Sparsentan Treatment in Pediatrics With Proteinuric Glomerular Diseases
ClinicalTrials.gov ID: NCT05003986
What this study is testing
What is Sparsentan?
This is an investigational oral medicine being studied as a potential treatment for kidney conditions like Focal Segmental Glomerulosclerosis (FSGS). It is designed to block specific signals in the body that can cause the kidneys to leak protein.
Also referred to as RE-021.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether sparsentan is safe and how well it lowers protein in the urine of children with certain kidney diseases.
- Who it's for
- You may be able to join if you are a child with focal segmental glomerulosclerosis, minimal change disease, IgA nephropathy, IgA vasculitis, or Alport syndrome.
- What's involved
- You will take one sparsentan tablet or drink one liquid dose every day. You will have regular check‑ins and blood and urine tests to see how the medicine works and if it causes side effects.
- Time commitment
- The study lasts 108 weeks, about two years, with visits every few months to monitor your health and test results.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 108 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 17
You may be able to join if
- The subject or parent/legal guardian (as appropriate) is willing and able to provide signed informed consent/assent, and where required, the subject...
- The subject has an estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m2 at screening.
- The subject is male or female ≥1 year at screening and \<18 years of age at Day 1 (Baseline).
- Kidney biopsy-proven FSGS or MCD histological patterns and clinical presentation consistent with primary FSGS or MCD and qualifying proteinuria at...
- Documentation of a genetic mutation in a podocyte protein associated with FSGS or MCD.
You likely can't join if
- The subject weighs \<7.3 kg at screening.
- The subject has FSGS or MCD histological pattern secondary to viral infections, drug toxicities, or malignancies.
- The subject has immunoglobulin A (IgA) glomerular deposits not in the context of primary IgAN or IgAV (ie, secondary to another condition
- The subject has had an acute onset or presentation of glomerular disease or a diagnostic biopsy or a relapse of glomerular disease requiring new or...
- people taking chronic immunosuppressive medications (including systemic steroids) not on a stable dose for ≥1 month before screening.
- The subject requires any of the prohibited concomitant medications as defined in the study protocol.
See the full eligibility criteria
- The subject or parent/legal guardian (as appropriate) is willing and able to provide signed informed consent/assent, and where required, the subject is willing to provide assent before any screening procedures per local...
- The subject has an estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m2 at screening.
- The subject is male or female ≥1 year at screening and \<18 years of age at Day 1 (Baseline).
- Kidney biopsy-proven FSGS or MCD histological patterns and clinical presentation consistent with primary FSGS or MCD and qualifying proteinuria at screening despite history or ongoing treatment with corticosteroids...
- Documentation of a genetic mutation in a podocyte protein associated with FSGS or MCD. people with a documented podocytic mutation do not require kidney biopsy.
- The subject is male or female ≥2 years at screening and \<18 years of age at Day 1 (Baseline).
- Kidney biopsy-confirmed IgAN, IgAV, or AS
- The subject is male or female ≥8 years at screening and \<18 years of age at Day 1 (Baseline).
- The subject has UP/C ≥1.0 g/g (113 mg/mmol) at screening AND has kidney biopsy-confirmed IgAN
- Subject weighs ≥40 kg
- The subject has been on ACEI and/or ARB therapy for at least 12 weeks prior to screening
- The subject weighs \<7.3 kg at screening.
- The subject has FSGS or MCD histological pattern secondary to viral infections, drug toxicities, or malignancies.
- The subject has immunoglobulin A (IgA) glomerular deposits not in the context of primary IgAN or IgAV (ie, secondary to another condition; eg, systemic lupus erythematosus and liver cirrhosis).
- The subject has had an acute onset or presentation of glomerular disease or a diagnostic biopsy or a relapse of glomerular disease requiring new or different class of immunosuppressive treatment (including, but not...
- people taking chronic immunosuppressive medications (including systemic steroids) not on a stable dose for ≥1 month before screening.
- The subject requires any of the prohibited concomitant medications as defined in the study protocol.
- The subject has undergone any organ transplantation, with the exception of corneal transplants.
- The subject has a documented history of congenital or acquired heart failure (modified Ross heart failure classification for children Class II to Class IV) and/or previous hospitalization for heart failure or...
- The subject has hemodynamically significant cardiac valvular disease.
- The subject has clinically significant congenital vascular disease.
- The subject has jaundice, hepatitis, or known hepatobiliary disease, or alanine aminotransferase and/or aspartate aminotransferase \>2 times the upper limit of the normal range at screening.
- The subject has a history of malignancy within the past 2 years.
- The subject has a screening hematocrit \<27% (0.27 L/L) or a hemoglobin value \<9 g/dL (90 g/L).
- The subject has a screening potassium value \>5.5 milliequivalent (mEq)/L (5.5 mmol/L).
- The subject has any abnormal clinical laboratory screening values that are considered by the Investigator to be clinically significant.
- The subject has a history of allergic response to any angiotensin II antagonist or endothelin receptor antagonist, including sparsentan, or has a hypersensitivity to any of the excipients in the study medication.
- The female subject is pregnant, plans to become pregnant during the course of the study, or is breastfeeding.
- Female people of childbearing potential, beginning at menarche, who do not agree to use 1 highly reliable (ie, can achieve a failure rate of \<1% per year) method of contraception from 7 days before the first dose of...
- The subject has participated in a study of another study medication within 28 days before screening or plans to participate in such a study during the course of this study.
- The subject has had prior exposure to sparsentan.
- The subject or parent/legal guardian (as appropriate), in the opinion of the Investigator, are unable to adhere to the requirements of the study including but not limited to, a history of noncompliance and/or any other...
- For Population 3 - the subject is unable to swallow the study medication tablets whole.
The study team makes the final eligibility decision.
Where it is enrolling
- Los Angeles, California, United States
- Wilmington, Delaware, United States
- Miami, Florida, United States
- Ann Arbor, Michigan, United States
- Minneapolis, Minnesota, United States
- Kansas City, Missouri, United States
- Hackensack, New Jersey, United States
- Neptune City, New Jersey, United States
- New Hyde Park, New York, United States
- Chapel Hill, North Carolina, United States
- Durham, North Carolina, United States
- Columbus, Ohio, United States
- Oklahoma City, Oklahoma, United States
- Philadelphia, Pennsylvania, United States
- Houston, Texas, United States
- Seattle, Washington, United States
- Cologne, Germany
- Hamburg, Germany
- Heidelberg, Germany
- Bari, Italy
+ 16 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 108 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 1 year to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Los Angeles, California, United States; Wilmington, Delaware, United States; Miami, Florida, United States; Ann Arbor, Michigan, United States; Minneapolis, Minnesota, United States; Kansas City, Missouri, United States and 30 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.