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

a study on IgA Nephropathy Glomerulonephritis

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Davis UCSF
Dates
study started
study ends around

Description

Summary

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.

Official Title

A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Povetacicept in Adults With Immunoglobulin A Nephropathy (RAINIER)

Keywords

Immunoglobulin A Nephropathy, IgAN, Berger's disease, glomerulonephritis, IgA nephropathy, ALPN-303, BAFF, BLyS, APRIL, IGA Glomerulonephritis, Counterfeit Drugs, Povetacicept

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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/1.73m2
  • Stable angiotensin converting enzyme inhibitor (ACEi) or angiotensin II receptor blocker (ARBs) as per protocol specification

You CAN'T join if...

  • 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

  • UC Davis Health accepting new patients
    Sacramento 5389489 California 5332921 95819 United States
  • Zuckerberg San Francisco General Hospital and Trauma Center accepting new patients
    San Francisco 5391959 California 5332921 94110 United States
  • University of California San Francisco (UCSF) accepting new patients
    San Francisco 5391959 California 5332921 94143 United States
  • The Medical Research Group, Inc. (FRENOVA) accepting new patients
    Fresno 5350937 California 5332921 93720 United States
  • Providence Medical Foundation - Orange accepting new patients
    Orange 5379513 California 5332921 92868 United States
  • CARE Institute - Carabello Kidney accepting new patients
    Los Angeles 5368361 California 5332921 90022 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Alpine Immune Sciences Inc, A Subsidiary of Vertex
ID
NCT06564142
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 480 study participants
Last Updated