RecruitingFocal Segmental GlomerulosclerosisMinimal Change DiseaseImmunoglobulin A Nephropathy

Study of Sparsentan Treatment in Pediatrics With Proteinuric Glomerular Diseases

Eligible age

1–17 yrs

Accepts

All genders

Locations

16 states

Healthy volunteers

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About this study

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.

Sponsor: Travere Therapeutics, Inc.

You may qualify if…

✓ 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 requirements.
✓ 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.
✓ 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 and/or other immunosuppressive disease-modifying agents.
✓ Documentation of a genetic mutation in a podocyte protein associated with FSGS or MCD. Subjects with a documented podocytic mutation do not require kidney biopsy.

You may not qualify if…

✕ 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 limited to, systemic corticosteroids, calcineurin inhibitors and mycophenolate mofetil, abatacept, cyclophosphamide, rituximab, ofatumumab, and ocrelizumab) within 6 months before screening.
✕ Subjects 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.