Proact: A Study of REACT in Subjects With Type 2 Diabetes Mellitus and Chronic Kidney Disease
Start Date
1/5/2022
Completion Date
12/1/2029
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.
Detailed Description
Randomized multi-center, blinded intervention, two cohort, study whereby eligible participants will be randomized 1:1, prior to kidney biopsy, to 1 of 2 cohorts. Cohort 1 participants will have scripted sham procedures that mimic the sounds and activities of biopsy, injection procedures, and evaluations as a control for Cohort 2 participants who will have a kidney biopsy followed with a rilparencel injection into the biopsied kidney, then, approximately 12 weeks later with a second rilparencel injection into the contralateral kidney. All participants will be followed until the global trial end date is declared.
Eligibility Criteria
Age Range: 30 years to 80 years
Interventions
Renal Autologous Cell Therapy (REACT/ rilparencel)
Sham Comparator
Conditions
Locations
Nephrology Consultants
Huntsville, Alabama 35805
United States
University of Arizona
Tucson, Arizona 85724
United States
Amicis Research Center
Beverly Hills, California 90211
United States
Paradise Clinical Research Group LLC
Glendora, California 91741
United States
Kidney Consultants Medical Group
Granada Hills, California 91344
United States
IMD Clinical Trials
Huntington Park, California 90255
United States
Advanced Medical Research, LLC
Lakewood, California 90712
United States
Medicine and Nephrology Associates
Los Alamitos, California 90720
United States
Academic Medical Research Institute
Los Angeles, California 90022
United States
Southern California Hospital
Los Angeles, California 90095
United States
Allameh Medical Corporation
Mission Viejo, California 92691
United States
Golden Pacific Nephrology Medical Clinic Inc
Monterey Park, California 91755
United States
Northridge Kidney Care Center
Northridge, California 91324
United States
Valley Renal Medical Group
Northridge, California 91324
United States
Valley Clinical Trials
Northridge, California 91325
United States
Integrity Medical Discovery
Pico Rivera, California 90660
United States
National Institute of Clinical Research
Pomona, California 91768
United States
Nephrology Associates Medical Group
Riverside, California 92505
United States
UC Davis Medical Group GI Unit
Sacramento, California 95817
United States
North America Research Institute
San Dimas, California 91773
United States
Henry Mayo Newhall Hospital
Valencia, California 91355
United States
Nephrology Associates PA
Newark, Delaware 19713
United States
West Broward Research Institute
Coral Springs, Florida 33313
United States
Florida Kidney Physicians
Fort Lauderdale, Florida 33316
United States
South Fort Lauderdale Nephrology
Fort Lauderdale, Florida 33316
United States
University of Florida
Gainesville, Florida 32608
United States
Mayo Clinic
Jacksonville, Florida 32224
United States
Ethos Palm Beach
Loxahatchee Groves, Florida 33470
United States
Global Clinix, LLC
Miami, Florida 33155
United States
Professional Research Center, Inc.
Miami, Florida 33172
United States
New Phase Clinical Trials
Miami Beach, Florida 33140
United States
Infigo Clinical Research
Sanford, Florida 32771
United States
Genesis Clinical Research
Tampa, Florida 33603
United States
American Clinical Trials
Acworth, Georgia 30101
United States
Wellstar Health System
Augusta, Georgia 30912
United States
Boise Kidney and Hypertension PLLC
Boise, Idaho 83706
United States
Care Institute
Chubbuck, Idaho 83202
United States
Insight Hospital & Medical Center Chicago
Chicago, Illinois 60616
United States
The University of Chicago Medical Center
Chicago, Illinois 60637
United States
Indiana Nephrology
Fishers, Indiana 46037
United States
Fresenius Kidney Care Mishawaka
Mishawaka, Indiana 46545
United States
University of Iowa
Iowa City, Iowa 52242
United States
Nephrology Associates of Lexington
Lexington, Kentucky 40504
United States
LSU Health Sciences Center
Shreveport, Louisiana 71103
United States
Washington Nephrology Associates
Takoma Park, Maryland 20854
United States
Holyoke Medical Center
Springfield, Massachusetts 01107
United States
University of Michigan
Ann Arbor, Michigan 48109
United States
Nephrology Center, PC
Kalamazoo, Michigan 49007
United States
St. Clair Nephrology Research
Roseville, Michigan 48066
United States
Southwest MS Nephrology
Brookhaven, Mississippi 39601
United States
Nephrology Associates
Columbus, Mississippi 39705
United States
Nephrology and Hypertension Associates
Tupelo, Mississippi 38801
United States
Saint Louis University
St Louis, Missouri 63110
United States
Nevada Kidney Disease & Hypertension Center
Las Vegas, Nevada 89052
United States
Seacoast Kidney & Hypertension Specialists
Portsmouth, New Hampshire 03801
United States
NYU Langone
New York, New York 10017
United States
ICAHN School of Medicine at Mount Sinai
New York, New York 10029
United States
Jacobi Medical Center
The Bronx, New York 10461
United States
UNC Chapel Hill
Chapel Hill, North Carolina 27514
United States
Lifespan Clinical Research Center
East Providence, Rhode Island 02915
United States
Rhode Island Hospital
Providence, Rhode Island 02903
United States
Dunes Clinical Research
Dakota Dunes, South Dakota 57049
United States
Knoxville Kidney Center
Knoxville, Tennessee 37923
United States
Vanderbilt University Medical Center
Nashville, Tennessee 37232
United States
Pioneer Research Solutions, Inc.
Cypress, Texas 77429
United States
Texas Tech Health Sciences
El Paso, Texas 79905
United States
Texas Tech University Health
El Paso, Texas 79905
United States
Plaza Nephrology
Houston, Texas 77004
United States
Biopharma Informatic, LLC
Houston, Texas 77043
United States
Prolato Clinical Research Center
Houston, Texas 77054
United States
Clinical Research Strategies, Inc
Houston, Texas 77090
United States
United Memorial Medical Center
Houston, Texas 77091
United States
Clinical Advancement Center, PLLC
San Antonio, Texas 78212
United States
University Health System
San Antonio, Texas 78229
United States
Prolato Clinical Research Center - Sugar Land
Sugar Land, Texas 77479
United States
Renal Physicians of Montgomery County
The Woodlands, Texas 77384
United States
Salem VA Medical Center
Salem, Virginia 24153
United States
Providence Medical Research Ctr
Spokane, Washington 99204
United States
University of Wisconsin-Madison
Madison, Wisconsin 53792
United States
St. George Hospital
Kogarah, New South Wales 2217
Australia
Lakeridge Health Corporation-Oshawa
Oshawa, Ontario
Canada
"Ignacio Chavez" National Cardiology Institute
Tlalpan, Mexico City 14080
Mexico
National Institute of Medical Sciences and Nutrition Salvador Zubiran
Tlalpan, Mexico City 14080
Mexico
Torre Medica San Lucas
Ponce, 00716
Puerto Rico
San Miguel Medical
Trujillo Alto, 00976
Puerto Rico
Far Eastern Memorial Hospital
New Taipei City, 220
Taiwan
Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare
New Taipei City, 23561
Taiwan
China Medical University Hospital
Taichung, 40447
Taiwan
Taichung Veterans General Hospital
Taichung,
Taiwan
National Taiwan University Hospital
Taipei, 100225
Taiwan
Taipei Medical University Hospital
Taipei, 110
Taiwan
Tri-Service General Hospital
Taipei, 11490
Taiwan
Taipei Municipal Wanfang Hospital Managed by Taipei Medical University
Taipei, 116
Taiwan
Taipei Municipal Wanfang Hospital
Taipei,
Taiwan
Royal London Hospital
London, E1 1FR
United Kingdom