Evaluation of Efficacy of Povetacicept in Adults With Immunoglobulin A Nephropathy (IgAN)
Phase 3 – large-scale trial before approval
Conditions:
Immunoglobulin A Nephropathy
Sponsor: Alpine Immune Sciences Inc, A Subsidiary of Vertex
trial.available_in:
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Overview
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.
Who can participate
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.
Locations
31
Australia (1)
Grampians Health Ballarat
Ballarat
Belgium (1)
Ziekenhuis Oost-Limburg
Genk
Brazil (1)
Centro de Pesquisa Clinica do Coracao
Aracaju
Canada (1)
St. Josephs Healthcare - Hamilton
Hamilton
China (1)
Beijing Tsinghua Changgung Hospital
Beijing
Croatia (1)
Clinical Hospital Dubrava
Zagreb
Czech Republic (1)
Fakultni Nemocnice Brno
Brno
Denmark (1)
Aalborg University Hospital
Aalborg
Estonia (1)
North Estonia Medical Centre Foundation
Tallinn
Finland (1)
Tampere University Hospital
Tampere
France (1)
Groupe Hospitalier Pellegrin, CHU De Bordeaux
Bordeaux
Hong Kong (1)
Queen Mary Hospital
Hong Kong
Hungary (1)
Pecsi Tudomanyegyetem Klinikai Kozpont
Pécs
Ireland (1)
Cork University Hospital
Cork
Israel (1)
Barzilai Medical Center
Ashkelon
Italy (1)
Azienda Ospedaliera Universitaria Consorziale - policlinicio Bari
Bari
Japan (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
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