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

a study on IgA Nephropathy Kidney Disease Glomerulonephritis

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion 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, Kidney Diseases, IGA Glomerulonephritis, 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

  • UCSF (UCSF) accepting new patients
    San Francisco California 94143 United States
  • The Medical Research Group, Inc. (FRENOVA) accepting new patients
    Fresno California 93720 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
Contact us about this trial