Phase 3Active, not recruiting
A Study to Evaluate the Efficacy and Safety of Sefaxersen (RO7434656) in Participants With Primary Immunoglobulin A (IgA) Nephropathy at High Risk of Progression (IMAGINATION)
A Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Sefaxersen, an Antisense Inhibitor of Complement Factor B, in Patients With Primary IgA Nephropathy at High Risk of Progression
- Sponsor
- Hoffmann-La Roche (Industry)
- Enrolment
- 459 enrolled
- Conditions
- Primary IgA Nephropathy
- Interventions
- Sefaxersen (RO7434656); Placebo
- Ages
- adults, older adults
- Registry
- NCT05797610
From the registry
The purpose of this study is to evaluate the efficacy, safety, \& pharmacokinetics of sefaxersen (RO7434656), a novel Antisense Oligonucleotide (ASO) therapy in participants with primary IgA nephropathy (IgAN) who are at high risk of progressive kidney disease despite optimized supportive care.
Primary outcomes
- Change From Baseline in the Urine Protein-to-Creatinine Ratio (UPCR) at Week 37