← Klinické štúdie • Glomerulopatie
A Study to Evaluate the Efficacy and Safety of Sefaxersen (RO7434656) in Participants With Primary Immunoglobulin A (IgA) Nephropathy at High Risk of Progression
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
Nábor prebieha
• Fáza 3 • intervenčná • NCT05797610
Stručný súhrn
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.
Základné údaje
| Ochorenia | Primary IgA Nephropathy |
|---|---|
| Intervencie |
DRUG: Sefaxersen (RO7434656) DRUG: Placebo |
| Sponzor | Hoffmann-La Roche |
| Plánovaný počet | 428 |
| Začiatok | 2023-08-08 |
| Predp. ukončenie (primárne) | 2026-08-31 |
| Krajiny | United States, Argentina, Australia, Brazil, Canada, China, Czechia, France, Germany, Greece, Hong Kong, Italy, Japan, Malaysia, Mexico, Poland, Singapore, South Korea, Spain, Taiwan, United Kingdom |
| Posledná aktualizácia | 2026-06-15 |
Upozornenie: údaje sú orientačné a podliehajú zmenám. Úplné vstupné/vylučovacie
kritériá, kontakty a aktuálny stav nájdete v oficiálnom registri. Tento prehľad
nenahrádza lekársku konzultáciu.