A study to evaluate the efficacy and safety of RO7434656 in participants with primary Immunoglobulin A (IgA) nephropathy at high risk of progression (IMAGINATION)
A study to evaluate the efficacy and safety of RO7434656 in participants with primary Immunoglobulin A (IgA) nephropathy at high risk of progression (IMAGINATION)
ClinicalTrials.gov ID: NCT05797610
Sponsor: Hoffmann-La Roche
Information provided by: Hoffmann-La Roche (Responsible Party)
Last Update Posted: 2024-07-08
Brief Summary:
The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of 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.
Official Title:
A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of RO7434656, an Antisense Inhibitor of Complement Factor B, in Patients With Primary IgA Nephropathy at High Risk of Progression
Intervention / Treatment:
- Drug: RO7434656
- Drug: Placebo
| Category | Value |
|---|---|
| Study Start (Actual) |
2023-08-08
|
| Primary Completion (Estimated) |
2026-09-30
|
| Study Completion (Estimated) |
2030-09-30
|
| Enrollment (Estimated) | 428 |
| Study Type | Interventional |
| Phase | Phase 3 |
| Other Study ID Numbers |
WA43966
2022-502102-32-00 (Other Identifier) (OTHER: EU Clinical Trial Number) |