Evaluation of Efficacy of Povetacicept in Adults With Immunoglobulin A Nephropathy (IgAN)
Фаза 3 – широко изпитване преди одобрение
Заболявания:
Immunoglobulin A Nephropathy
Спонсор: Alpine Immune Sciences Inc, A Subsidiary of Vertex
Налично на:
БГ
Обобщение
The purpose of this study is to evaluate the efficacy of povetacicept in adult participants compared with placebo in reducing proteinuria and preserving renal function.
Кой може да участва
Key Inclusion Criteria:
* Diagnosed IgAN, with biopsy confirmation
* 24-hr proteinuria excretion ≥1.0 g/day or 24-hour uPCR ≥0.75 g/g
* Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73m\^2
* Stable angiotensin converting enzyme inhibitor (ACEi) or angiotensin II receptor blocker (ARBs) as per protocol specification
Key Exclusion Criteria:
* Have received any immunosuppressive treatment or procedures (including corticosteroids, oral immunosuppressive agents, B cell or plasma cell targeted therapies, complement targeted therapies, herbal medicines per protocol, and tonsillectomy) within a wash-out period per protocol
* Rapidly progressive glomerulonephritis with eGFR reduction \>50% within 12 weeks of the start of screening
Other protocol defined Inclusion/Exclusion criteria may apply.
Места на провеждане
31
Австралия (1)
Grampians Health Ballarat
Ballarat
Белгия (1)
Ziekenhuis Oost-Limburg
Genk
Бразилия (1)
Centro de Pesquisa Clinica do Coracao
Aracaju
Канада (1)
St. Josephs Healthcare - Hamilton
Hamilton
Китай (1)
Beijing Tsinghua Changgung Hospital
Beijing
Хърватия (1)
Clinical Hospital Dubrava
Zagreb
Чехия (1)
Fakultni Nemocnice Brno
Brno
Дания (1)
Aalborg University Hospital
Aalborg
Estonia (1)
North Estonia Medical Centre Foundation
Tallinn
Финландия (1)
Tampere University Hospital
Tampere
Франция (1)
Groupe Hospitalier Pellegrin, CHU De Bordeaux
Bordeaux
Hong Kong (1)
Queen Mary Hospital
Hong Kong
Унгария (1)
Pecsi Tudomanyegyetem Klinikai Kozpont
Pécs
Ireland (1)
Cork University Hospital
Cork
Израел (1)
Barzilai Medical Center
Ashkelon
Италия (1)
Azienda Ospedaliera Universitaria Consorziale - policlinicio Bari
Bari
Япония (1)
Fujita Health University Hos
Aichi
Latvia (1)
Paula Stradina Clinical University Hospital
Riga
Lithuania (1)
Hospital of Lithuanian University of Health Sciences (LSMU) Kauno klinikos
БГ
EN