A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Povetacicept in Adults with Immunoglobulin A Nephropathy (RAINIER).
Phase 3 – large-scale trial before approval
Conditions:
Immunoglobulin A Nephropathy
Sponsor: Alpine Immune Sciences Inc.
trial.available_in:
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Overview
Trial status: Authorised
3. Change From Baseline in eGFR at Week 104 [Time Frame: From Baseline at Week 104]., 4. Time to Kidney Disease Progression Through Week 104 Kidney disease progression defined as greater than or equal to (≥) 30% decline in eGFR, end stage kidney disease, or non-accidental death. [Time Frame: From Baseline Through Week 104]., 1. Change from baseline in serum Gd-IgA1 at Week 36, 2. Proportion of subjects to achieve hematuria resolution at Week 36 (among subjects with hematuria at baseline)
1. Change From Baseline in 24-hour Urine Protein to Creatinine Ratio (uPCR) at Week 36 [Time Frame: From Baseline at Week 36]., 2. Total Estimated Glomerular Filtration Rate (eGFR) Slope Through Week 104 [Time Frame: From Baseline Through Week 104].
Description
3. Change From Baseline in eGFR at Week 104 [Time Frame: From Baseline at Week 104]., 4. Time to Kidney Disease Progression Through Week 104 Kidney disease progression defined as greater than or equal to (≥) 30% decline in eGFR, end stage kidney disease, or non-accidental death. [Time Frame: From Baseline Through Week 104]., 1. Change from baseline in serum Gd-IgA1 at Week 36, 2. Proportion of subjects to achieve hematuria resolution at Week 36 (among subjects with hematuria at baseline)
Who can participate
Age group: 65+ years, 18-64 years
Gender: Female, Male
Target enrollment: 181 participants
Interventions
ALPN-303 solution for injection
Drug
Test IMP without active substance
Drug
Test IMP ALPN-303 pre-filled syringe without active substance
Drug
ALPN-303 solution for injection in pre-filled syringe
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