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.
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 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.
Parallel
Sparsentan
DrugPopulation 1: 800 mg Sparsentan (oral suspension)
Sparsentan
DrugPopulation 2: 400 mg Sparsentan (oral suspension)
Sparsentan
DrugPopulation 3: 400 mg Sparsentan (tablets)
Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), AEs leading to treatment discontinuation, and adverse events of interest (AEOIs)
The incidence of TEAEs, SAEs, AEs leading to treatment discontinuation, and AEOIs
Urine protein/creatinine ratio (UP/C) at week 108
Change from baseline in UP/C over 108 weeks
Observed plasma Pharmacokinetic (PK) concentrations
Observed plasma PK concentrations at scheduled timepoints and visits
Steady-state PK parameters area under the plasma concentration-time curve during a dosing interval ([AUCτ])
Steady-state PK parameters \[AUCτ\]
Steady-state PK parameters [Cmax_ss]
Maximum steady-state plasma drug concentration \[Cmax\_ss\]
Steady-state PK parameters [Cmin_ss]
Minimum steady-state plasma drug concentration \[Cmin\_ss\]
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