ACTIVE_NOT_RECRUITING

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

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Conditions

Immunoglobulin A NephropathyIgANBerger's diseaseglomerulonephritisIgA nephropathyALPN-303BAFFBLySAPRIL

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-08-30
Study Completion:2028-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06564142

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnosed IgAN, with biopsy confirmation
  2. * 24-hr proteinuria excretion ≥1.0 g/day or 24-hour uPCR ≥0.75 g/g
  3. * Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73m\^2
  4. * Stable angiotensin converting enzyme inhibitor (ACEi) or angiotensin II receptor blocker (ARBs) as per protocol specification
  1. * 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
  2. * Rapidly progressive glomerulonephritis with eGFR reduction \>50% within 12 weeks of the start of screening

Contacts and Locations

Study Locations (Sites)

Apogee Clinical Research, LLC
Huntsville, Alabama, 35805
United States
Arizona Kidney Disease and Hypertension Center - Thomas Office
Phoenix, Arizona, 85016
United States
Arizona Kidney Disease and Hypertension Center - Tuscon
Tucson, Arizona, 85741
United States
West Coast Kidney
Fremont, California, 94538
United States
The Medical Research Group, Inc. (FRENOVA)
Fresno, California, 93720
United States
CARE Institute - Carabello Kidney
Los Angeles, California, 90022
United States
Providence Medical Foundation - Orange
Orange, California, 92868
United States
National Nephrology Alliance Research
Riverside, California, 92505
United States
UC Davis Health
Sacramento, California, 95819
United States
Zuckerberg San Francisco General Hospital and Trauma Center
San Francisco, California, 94110
United States
University of California San Francisco (UCSF)
San Francisco, California, 94143
United States
Western Nephrology
Arvada, Colorado, 80002
United States
Colorado Kidney Care
Denver, Colorado, 80230
United States
Nephrology Associates Delaware Kidney (FRENOVA)
Newark, Delaware, 19713
United States
South Florida Nephrology Group PA, Research Div.
Coral Springs, Florida, 33071
United States
Dolphin Medical Research
Doral, Florida, 33172
United States
Nephrology Associates of Central Florida
Hollywood, Florida, 32806
United States
Tectum Medical Research, LLC
Hollywood, Florida, 33024
United States
South Florida Research Institute
Lauderdale Lakes, Florida, 33313
United States
Florida Kidney Physicians - Melbourne
Melbourne, Florida, 32901
United States
Med-Care Research
Miami, Florida, 33125
United States
Professional Research Center
Miami, Florida, 33172
United States
Nephrology Associates of South Miami
Miami, Florida, 33173
United States
On Health Research Center
Miami, Florida, 33186
United States
Combined Research Orlando Phase I-IV
Orlando, Florida, 32807
United States
BioResearch Partner
Pembroke Pines, Florida, 33029
United States
D&H Pompano Research Center
Pompano Beach, Florida, 33064
United States
Cordova Research Institute, LLC
Sweetwater, Florida, 33182
United States
SciMerge Clinical Research
Atlanta, Georgia, 30274
United States
Georgia Nephrology - Lawrenceville
Lawrenceville, Georgia, 30046
United States
Randomize Now - Midtown
Newnan, Georgia, 30269
United States
Care Institute - Chubbuck, ID
Chubbuck, Idaho, 83202
United States
Care Institute - Idaho Falls
Idaho Falls, Idaho, 83404
United States
CARE - Boise Kidney Institute
Meridian, Idaho, 83642
United States
Bioluminux Clinical Research
Naperville, Illinois, 60540
United States
Rockford Nephrology Associates
Rockford, Illinois, 61107
United States
Nephrology Associates of Northern Illinois and Indiana (NANI)
Indianapolis, Indiana, 46227
United States
Nephrology Physicians LLC
Mishawaka, Indiana, 46545
United States
Nephrology Associates of Kentuckiana
Louisville, Kentucky, 40205
United States
Renal Associates of Baton Rouge
Baton Rouge, Louisiana, 70808
United States
Velocity Clinical Research - Metairie
Metairie, Louisiana, 70006
United States
Johns Hopkins School of Medicine
Baltimore, Maryland, 21287
United States
St. Clair Nephrology Research
Shelby, Michigan, 48315
United States
InterMed Consultants / DaVita Clinical Research, Edina
Edina, Minnesota, 55404
United States
Mayo Clinic - Rochester
Rochester, Minnesota, 55905
United States
Nephrology and Hypertension Associates, LTD
Tupelo, Mississippi, 38801
United States
Washington University in St. Louis
St Louis, Missouri, 63110
United States
Somnos Clinical Research
Lincoln, Nebraska, 68505
United States
DaVita Clinical Research Nevada - Las Vegas
Las Vegas, Nevada, 89129
United States
Bioluminux Clinical Research New Jersey
Hamilton, New Jersey, 08690
United States
New Jersey Kidney Care, LLC (FRENOVA)
Jersey City, New Jersey, 07305
United States
Renal Medicine Associates
Albuquerque, New Mexico, 87109
United States
New York Nephrology Vasculitis and Glomerular Center
Albany, New York, 12209
United States
Queens Hospital Center
Jamaica, New York, 11432
United States
The Rogosin Institute
New York, New York, 10021
United States
Metrolina Nephrology Associates
Charlotte, North Carolina, 28208
United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
United States
Nephrology Associates Inc
East Providence, Rhode Island, 02914
United States
Hypertension & Nephrology Inc.
Providence, Rhode Island, 02904
United States
South Carolina Clinical Research, LLC
Orangeburg, South Carolina, 29118
United States
Knoxville Kidney Center (KKC), PLLC
Knoxville, Tennessee, 37923
United States
Velocity Clinical Research
Abilene, Texas, 79606
United States
Introscience Research LLC
Bellaire, Texas, 77401
United States
Dallas Renal Group
Dallas, Texas, 75230
United States
Renal Disease Research Institute - Dallas
Dallas, Texas, 75264
United States
Davita Clinical Research - El Paso
El Paso, Texas, 79925
United States
Prolato Clinical Research Center
Houston, Texas, 77054
United States
Houston Medical Research Institute, LLC (FRENOVA)
Houston, Texas, 77074
United States
R & H Clinical Research
Katy, Texas, 77450
United States
North Texas Kidney Disease Associates
Lewisville, Texas, 75057
United States
P&I Clinical Research, LLC
Lufkin, Texas, 75904
United States
Renal Specialists of Houston
Pasadena, Texas, 77504
United States
Utah Kidney Research Institute
Salt Lake City, Utah, 84115
United States
University of Vermont
Burlington, Vermont, 05401
United States
Virginia Nephrology Group
Fairfax, Virginia, 22101
United States
Kidney and Hypertension Specialist PLLC
Manassas, Virginia, 20110
United States

Collaborators and Investigators

Sponsor: Alpine Immune Sciences Inc, A Subsidiary of Vertex

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-30
Study Completion Date2028-09-30

Study Record Updates

Study Start Date2024-08-30
Study Completion Date2028-09-30

Terms related to this study

Keywords Provided by Researchers

  • IgAN
  • Berger's disease
  • glomerulonephritis
  • IgA nephropathy
  • ALPN-303
  • BAFF
  • BLyS
  • APRIL

Additional Relevant MeSH Terms

  • Immunoglobulin A Nephropathy