Randomized Phase II JANUS Study of Atacicept in Patients With IgA Nephropathy and Persistent Proteinuria

Autor: Jonathan, Barratt, James, Tumlin, Yusuke, Suzuki, Amy, Kao, Aida, Aydemir, Kishore, Pudota, Hulin, Jin, Hans, Gühring, Gerald, Appel
Rok vydání: 2022
Předmět:
Zdroj: Kidney International Reports. 7:1831-1841
ISSN: 2468-0249
Popis: Patients with IgA nephropathy (IgAN) and persistent proteinuria are at risk of progression to kidney failure. Atacicept is a novel B-cell-targeted immunomodulator, shown to reduce immunoglobulin levels in patients with autoimmune diseases.JANUS (NCT02808429) was a phase II study that assessed the safety, pharmacodynamic effects, and efficacy of atacicept in patients with IgAN and proteinuria ≥1 g/d or 0.75 mg/mg on 24-hour UPCR despite maximal standard of care therapy.A total of 16 patients were randomized 1:1:1 to placebo (Atacicept has an acceptable safety profile in patients with IgAN and is effective at reducing the levels of pathogenic factor Gd-IgA1, with potential improvements in proteinuria and renal function.
Databáze: OpenAIRE