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Proact: A Study of REACT in Subjects With Type 2 Diabetes Mellitus and Chronic Kidney Disease
Sponsor: Prokidney
Summary
The purpose of this study is to assess the safety and efficacy of up to 2 REACT/rilparencel injections in participants with T2DM and CKD.
Official title: A Phase 3 Randomized Controlled Study of Renal Autologous Cell Therapy (REACT) in Subjects With Type 2 Diabetes and Chronic Kidney Disease (REGEN-006)
Key Details
Gender
All
Age Range
30 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
685
Start Date
2022-01-05
Completion Date
2029-12
Last Updated
2026-03-23
Healthy Volunteers
No
Interventions
Renal Autologous Cell Therapy (REACT/ rilparencel)
Participants will have a kidney biopsy followed approximately12 weeks later with a rilparencel injection into the biopsied kidney, then, approximately 12 weeks later a rilparencel injection into their contralateral kidney.
Sham Comparator
Participants will have sham procedures that simulate real biopsy and injection procedure. No tissue is taken during biopsy and nothing is injected into kidney. The 2 injection/ sham procedures will occur approximately 12 weeks apart.
Locations (95)
Nephrology Consultants
Huntsville, Alabama, United States
University of Arizona
Tucson, Arizona, United States
Amicis Research Center
Beverly Hills, California, United States
Paradise Clinical Research Group LLC
Glendora, California, United States
Kidney Consultants Medical Group
Granada Hills, California, United States
IMD Clinical Trials
Huntington Park, California, United States
Advanced Medical Research, LLC
Lakewood, California, United States
Medicine and Nephrology Associates
Los Alamitos, California, United States
Academic Medical Research Institute
Los Angeles, California, United States
Southern California Hospital
Los Angeles, California, United States
Allameh Medical Corporation
Mission Viejo, California, United States
Golden Pacific Nephrology Medical Clinic Inc
Monterey Park, California, United States
Northridge Kidney Care Center
Northridge, California, United States
Valley Renal Medical Group
Northridge, California, United States
Valley Clinical Trials
Northridge, California, United States
Integrity Medical Discovery
Pico Rivera, California, United States
National Institute of Clinical Research
Pomona, California, United States
Nephrology Associates Medical Group
Riverside, California, United States
UC Davis Medical Group GI Unit
Sacramento, California, United States
North America Research Institute
San Dimas, California, United States
Henry Mayo Newhall Hospital
Valencia, California, United States
Nephrology Associates PA
Newark, Delaware, United States
West Broward Research Institute
Coral Springs, Florida, United States
Florida Kidney Physicians
Fort Lauderdale, Florida, United States
South Fort Lauderdale Nephrology
Fort Lauderdale, Florida, United States
University of Florida
Gainesville, Florida, United States
Mayo Clinic
Jacksonville, Florida, United States
Ethos Palm Beach
Loxahatchee Groves, Florida, United States
Global Clinix, LLC
Miami, Florida, United States
Professional Research Center, Inc.
Miami, Florida, United States
New Phase Clinical Trials
Miami Beach, Florida, United States
Infigo Clinical Research
Sanford, Florida, United States
Genesis Clinical Research
Tampa, Florida, United States
American Clinical Trials
Acworth, Georgia, United States
Wellstar Health System
Augusta, Georgia, United States
Boise Kidney and Hypertension PLLC
Boise, Idaho, United States
Care Institute
Chubbuck, Idaho, United States
Insight Hospital & Medical Center Chicago
Chicago, Illinois, United States
The University of Chicago Medical Center
Chicago, Illinois, United States
Indiana Nephrology
Fishers, Indiana, United States
Fresenius Kidney Care Mishawaka
Mishawaka, Indiana, United States
University of Iowa
Iowa City, Iowa, United States
Nephrology Associates of Lexington
Lexington, Kentucky, United States
LSU Health Sciences Center
Shreveport, Louisiana, United States
Washington Nephrology Associates
Takoma Park, Maryland, United States
Holyoke Medical Center
Springfield, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Nephrology Center, PC
Kalamazoo, Michigan, United States
St. Clair Nephrology Research
Roseville, Michigan, United States
Southwest MS Nephrology
Brookhaven, Mississippi, United States
Nephrology Associates
Columbus, Mississippi, United States
Nephrology and Hypertension Associates
Tupelo, Mississippi, United States
Saint Louis University
St Louis, Missouri, United States
Nevada Kidney Disease & Hypertension Center
Las Vegas, Nevada, United States
Seacoast Kidney & Hypertension Specialists
Portsmouth, New Hampshire, United States
NYU Langone
New York, New York, United States
ICAHN School of Medicine at Mount Sinai
New York, New York, United States
Jacobi Medical Center
The Bronx, New York, United States
UNC Chapel Hill
Chapel Hill, North Carolina, United States
Lifespan Clinical Research Center
East Providence, Rhode Island, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Dunes Clinical Research
Dakota Dunes, South Dakota, United States
Knoxville Kidney Center
Knoxville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Pioneer Research Solutions, Inc.
Cypress, Texas, United States
Texas Tech Health Sciences
El Paso, Texas, United States
Texas Tech University Health
El Paso, Texas, United States
Plaza Nephrology
Houston, Texas, United States
Biopharma Informatic, LLC
Houston, Texas, United States
Prolato Clinical Research Center
Houston, Texas, United States
Clinical Research Strategies, Inc
Houston, Texas, United States
United Memorial Medical Center
Houston, Texas, United States
Clinical Advancement Center, PLLC
San Antonio, Texas, United States
University Health System
San Antonio, Texas, United States
Prolato Clinical Research Center - Sugar Land
Sugar Land, Texas, United States
Renal Physicians of Montgomery County
The Woodlands, Texas, United States
Salem VA Medical Center
Salem, Virginia, United States
Providence Medical Research Ctr
Spokane, Washington, United States
University of Wisconsin-Madison
Madison, Wisconsin, United States
St. George Hospital
Kogarah, New South Wales, Australia
Lakeridge Health Corporation-Oshawa
Oshawa, Ontario, Canada
"Ignacio Chavez" National Cardiology Institute
Tlalpan, Mexico City, Mexico
National Institute of Medical Sciences and Nutrition Salvador Zubiran
Tlalpan, Mexico City, Mexico
Torre Medica San Lucas
Ponce, Puerto Rico
San Miguel Medical
Trujillo Alto, Puerto Rico
Far Eastern Memorial Hospital
New Taipei City, Taiwan
Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare
New Taipei City, Taiwan
China Medical University Hospital
Taichung, Taiwan
Taichung Veterans General Hospital
Taichung, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Taipei Medical University Hospital
Taipei, Taiwan
Tri-Service General Hospital
Taipei, Taiwan
Taipei Municipal Wanfang Hospital Managed by Taipei Medical University
Taipei, Taiwan
Taipei Municipal Wanfang Hospital
Taipei, Taiwan
Royal London Hospital
London, United Kingdom