drugset / Trial / NCT05797610

A Study to Evaluate the Efficacy and Safety of Sefaxersen (RO7434656) in Participants With Primary Immunoglobulin A (IgA) Nephropathy at High Risk of Progression

NCT05797610 ↗

Phase 3 Recruiting 428 enrolled Hoffmann-La Roche
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to evaluate the efficacy, safety, and 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.

Timeline

Start
2023-08-08
Primary completion
2026-08-31
Completion
2029-03-31

Drugs

EvaluationDrugModalityDoseRoute
Subject IONIS-FB-LRx Antisense oligonucleotide — Subcutaneous