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New treatment option for Focal Segmental Glomerulosclerosis
Official title Study of Sparsentan Treatment in Pediatrics With Proteinuric Glomerular Diseases
ClinicalTrials.gov ID: NCT05003986
What this study is testing
What is Sparsentan?
Sparsentan is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for focal segmental glomerulosclerosis.
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
- 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.
- 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
- for All people (All Three Populations): A subject must meet all of the following criteria to be eligible for participation in this study:
- 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 has a mean seated blood pressure between the 5th and 95th percentile for sex and height. for Population 1:
- The subject is male or female ≥1 year at screening and \<18 years of age at Day 1 (Baseline).
You likely can't join if
- for All people (All Three Populations): A subject who meets any of the following will be excluded from this study:
- 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...
- 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.
See the full eligibility criteria
Who can join
- for All people (All Three Populations): A subject must meet all of the following criteria to be eligible for participation in this study:
- 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 has a mean seated blood pressure between the 5th and 95th percentile for sex and height. for Population 1:
- The subject is male or female ≥1 year at screening and \<18 years of age at Day 1 (Baseline).
- The subject has a UP/C ≥1.5 g/g (170 mg/mmol) at screening AND one of the following:
- 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.
- Kidney biopsy-proven FSGS histological pattern with medical history and clinical presentation consistent with maladaptive cause of the lesion. Note: The kidney biopsy may have been performed at any time in the past but...
- The subject is male or female ≥2 years at screening and \<18 years of age at Day 1 (Baseline).
- The subject has UP/C ≥0.6 g/g (68 mg/mmol) at screening AND one of the following diagnoses:
- Kidney biopsy-confirmed IgAN, IgAV, or AS
- Diagnosis of AS by genetic testing (pathogenic X-linked Collagen, Type IV, Alpha-5 (COL4A5) mutation OR autosomal-recessive mutations in both alleles of Collagen, Type IV, Alpha-3 (COL4A3) and/or Collagen, Type IV...
- 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
What rules you out
- for All people (All Three Populations): A subject who meets any of the following will be excluded from this study:
- 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's taking place
- Los Angeles, California, United States
- Wilmington, Delaware, United States
- Miami, Florida, United States
- Iowa City, Iowa, United States
- Boston, Massachusetts, 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
- New York, New York, United States
- Chapel Hill, North Carolina, United States
- Charlotte, 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
+ 23 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 - 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?
Study sites include Los Angeles, California, United States; Wilmington, Delaware, United States; Miami, Florida, United States; Iowa City, Iowa, United States; Boston, Massachusetts, United States; Ann Arbor, Michigan, United States and 37 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.