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

Description

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.

Conditions

Immunoglobulin A Nephropathy

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Study Overview

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Study Details

Study 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.

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

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

Condition
Immunoglobulin A Nephropathy
Intervention / Treatment

-

Contacts and Locations

Huntsville

Apogee Clinical Research, LLC, Huntsville, Alabama, United States, 35805

Phoenix

Arizona Kidney Disease and Hypertension Center - Thomas Office, Phoenix, Arizona, United States, 85016

Tucson

Arizona Kidney Disease and Hypertension Center - Tuscon, Tucson, Arizona, United States, 85741

Los Angeles

CARE Institute - Carabello Kidney, Los Angeles, California, United States, 90022

Arvada

Western Nephrology, Arvada, Colorado, United States, 80002

Coral Springs

South Florida Nephrology Group PA, Research Div., Coral Springs, Florida, United States, 33071

Hollywood

Nephrology Associates of Central Florida, Hollywood, Florida, United States, 32806

Hollywood

Tectum Medical Research, LLC, Hollywood, Florida, United States, 33024

Melbourne

Florida Kidney Physicians - Melbourne, Melbourne, Florida, United States, 32901

Atlanta

SciMerge Clinical Research, Atlanta, Georgia, United States, 30274

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Alpine Immune Sciences Inc, A Subsidiary of Vertex,

Study Record Dates

2028-09