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Sparsentan in Incident and Recurrent IgA Nephropathy
NCT04663204Phase 2
Key facts
- Status
- Recruiting
- Start
- Dec 2020
- Primary completion
- Dec 2027
- Countries
- 1
- Sponsor
- University of Leicester
- Modality
- Small Molecules
- Drugs
- sparsentan
- Conditions
- immunoglobulin A nephropathy (IgAN)
01
Overview
Phase 2, randomised, open-label trial of sparsentan in immunoglobulin A nephropathy (IgAN) (3 cohorts), sponsored by University of Leicester. Primary endpoint: Urine protein/creatinine ratio at 36 weeks. Started Dec 2020; status: recruiting.
02
Design
3 arms- Study design
- RandomizedOpen-label
Cohort A: Incident IgAN
Incident, RAS blockade-naive patients receiving sparsentan for 110 weeks.
Cohort B: Early Sparsentan
Recurrent IgAN patients receiving sparsentan + SOC for 48 weeks.
Cohort B: Delayed Sparsentan
Recurrent IgAN patients receiving SOC for 24 weeks, then sparsentan + SOC for 24 weeks.
03
Who it enrols
Adults with biopsy-proven incident or recurrent (post-transplant) IgA nephropathy, with adequate kidney function (eGFR >= 25-30) and proteinuria, excluding those with uncontrolled diabetes, severe heart failure, or recent malignancies.
04
Endpoints
Primary
Urine protein/creatinine ratio
Secondary
Estimated Glomerular Filtration Rate
Change from baseline in proteinuria
Abnormalities in clinical laboratory assessments and vital signs
Incidence of adverse events
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