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Evaluation of Efficacy of Povetacicept in Adults With Immunoglobulin A Nephropathy (IgAN)

Sponsored by Alpine Immune Sciences Inc, A Subsidiary of Vertex

About this trial

Last updated 8 months ago

Study ID

VX24-AIS-D08

Status

Recruiting

Type

Interventional

Phase

Phase 3

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Started a year ago

What is this trial about?

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.

What are the Participation Requirements?

Key Inclusion Criteria:

- Diagnosed IgAN, with biopsy confirmation within 10 years of screening

- 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.