A Randomized Clinical Trial of Kidney Autologous Cell Therapy in Diabetic Kidney Disease.
Borut Čižman, Emily L Butler, Joseph Stavas...
https://pubmed.ncbi.nlm.nih.gov/41481370Actively Recruiting
Phase 3
Age: 30Years - 80Years
All Genders
ID05099770
A Phase 3 Randomized Controlled Study of Renal Autologous Cell Therapy (REACT) in Adults With Type 2 Diabetes and Chronic Kidney Disease
Led by Prokidney · Updated on 2026-03-23
685
Participants Needed
95
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of up to two injections of REACT/rilparencel in adults with type 2 diabetes mellitus and chronic kidney disease. This phase 3, randomized, blinded study compares participants receiving two REACT/rilparencel injections to those undergoing sham procedures that simulate the biopsy and injection steps without actual treatment. The study aims to understand how this therapy might impact kidney function and disease progression. Participants are randomly assigned to one of two groups. The experimental group will receive a kidney biopsy followed by a rilparencel injection into the biopsied kidney, then about 12 weeks later, a second injection into the other kidney. The control group undergoes two sham procedures spaced approximately 12 weeks apart that mimic the real treatment steps but involve no actual biopsy or injection. All participants are followed until the study ends in 2029. During the study, participants will have kidney biopsies or sham procedures, followed by injections or sham injections. Researchers will monitor kidney function through measures like estimated glomerular filtration rate (eGFR) over up to 94 months. They will also assess clinical outcomes such as kidney failure events, death, and quality of life changes. Safety and efficacy are observed through regular visits and evaluations throughout the trial.
CONDITIONS
Brief Title
Proact: A Study of REACT in Subjects With Type 2 Diabetes Mellitus and Chronic Kidney Disease
Who Can Participate
Age: 30Years - 80Years
All Genders
Eligibility Criteria
You may qualify if you...
- Male or female aged 30 to 80 years at the time of informed consent
- Documented diagnosis of type 2 diabetes mellitus and chronic kidney disease
- Serum glycosylated hemoglobin (HbA1c) of 9.5% or lower at screening
- Systolic blood pressure ≤ 140 mm Hg and diastolic blood pressure ≤ 90 mm Hg at screening
- Strong consideration for treatment with sodium-glucose cotransporter 2 inhibitor (SGLT2i)
- On a clinically relevant, maximally tolerated dose of an angiotensin converting-enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB), unless not tolerated or contraindicated
- Willing and able to avoid therapies that increase bleeding risk during specified pre- and post-procedure periods
- Able and willing to cooperate with all protocol requirements and provide signed informed consent
You will not qualify if you...
- History of type 1 diabetes mellitus
- History of renal or other organ transplantation
- Any other known underlying cause of kidney disease
- Acute kidney injury or major surgery within 3 months prior to screening
- Myocardial infarction, unstable angina, revascularization, or stroke within 12 weeks before randomization or planned revascularization during the trial
- Current or history of New York Heart Association Class IV heart failure
- History of exclusionary malignancy within 3 years prior to screening
- Clinically significant liver disease including hepatitis B or C
- Known infection with HIV, active syphilis, unresolved genitourinary infection, or active tuberculosis requiring treatment
- Immunocompromised condition or chronic immunosuppressive treatment within 3 months before consent
- Recent bleeding event, bleeding disorder, or increased risk of thromboembolism or bleeding
- Kidney imaging shows contraindications for biopsy or rilparencel injection
- Use of anticoagulant agents
- History of severe allergic reactions to blood products, Dextran 40, bovine products, local anesthetics, or sedatives
- Use of investigational product or device within 12 weeks prior to randomization or previous treatment with rilparencel
- Health condition that would jeopardize safety or study participation as judged by the investigator
AI-Screening
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Approximately 24 weeks
Participants receive either two injections of REACT/rilparencel or two sham procedures approximately 12 weeks apart.
2 visits approximately 12 weeks apart (in-person)
Long-term Monitoring
Duration - Up to 94 months
Participants are followed until the global trial end date to monitor kidney function and health outcomes.
Follow-up visits schedule varies; details provided by study staff
Trial Site Locations
Total: 95 locations
1
Nephrology Consultants
Huntsville, Alabama, United States, 35805
Actively Recruiting
2
University of Arizona
Tucson, Arizona, United States, 85724
Actively Recruiting
3
Amicis Research Center
Beverly Hills, California, United States, 90211
Active, Not Recruiting
4
Paradise Clinical Research Group LLC
Glendora, California, United States, 91741
Withdrawn
5
Kidney Consultants Medical Group
Granada Hills, California, United States, 91344
Active, Not Recruiting
6
IMD Clinical Trials
Huntington Park, California, United States, 90255
Actively Recruiting
7
Advanced Medical Research, LLC
Lakewood, California, United States, 90712
Actively Recruiting
8
Medicine and Nephrology Associates
Los Alamitos, California, United States, 90720
Actively Recruiting
9
Academic Medical Research Institute
Los Angeles, California, United States, 90022
Actively Recruiting
10
Southern California Hospital
Los Angeles, California, United States, 90095
Actively Recruiting
11
Allameh Medical Corporation
Mission Viejo, California, United States, 92691
Completed
12
Golden Pacific Nephrology Medical Clinic Inc
Monterey Park, California, United States, 91755
Actively Recruiting
13
Northridge Kidney Care Center
Northridge, California, United States, 91324
Active, Not Recruiting
14
Valley Renal Medical Group
Northridge, California, United States, 91324
Actively Recruiting
15
Valley Clinical Trials
Northridge, California, United States, 91325
Actively Recruiting
16
Integrity Medical Discovery
Pico Rivera, California, United States, 90660
Active, Not Recruiting
17
National Institute of Clinical Research
Pomona, California, United States, 91768
Actively Recruiting
18
Nephrology Associates Medical Group
Riverside, California, United States, 92505
Actively Recruiting
19
UC Davis Medical Group GI Unit
Sacramento, California, United States, 95817
Actively Recruiting
20
North America Research Institute
San Dimas, California, United States, 91773
Actively Recruiting
21
Henry Mayo Newhall Hospital
Valencia, California, United States, 91355
Active, Not Recruiting
22
Nephrology Associates PA
Newark, Delaware, United States, 19713
Actively Recruiting
23
West Broward Research Institute
Coral Springs, Florida, United States, 33313
Active, Not Recruiting
24
Florida Kidney Physicians
Fort Lauderdale, Florida, United States, 33316
Completed
25
South Fort Lauderdale Nephrology
Fort Lauderdale, Florida, United States, 33316
Actively Recruiting
26
University of Florida
Gainesville, Florida, United States, 32608
Actively Recruiting
27
Mayo Clinic
Jacksonville, Florida, United States, 32224
Actively Recruiting
28
Ethos Palm Beach
Loxahatchee Groves, Florida, United States, 33470
Actively Recruiting
29
Global Clinix, LLC
Miami, Florida, United States, 33155
Actively Recruiting
30
Professional Research Center, Inc.
Miami, Florida, United States, 33172
Actively Recruiting
31
New Phase Clinical Trials
Miami Beach, Florida, United States, 33140
Actively Recruiting
32
Infigo Clinical Research
Sanford, Florida, United States, 32771
Actively Recruiting
33
Genesis Clinical Research
Tampa, Florida, United States, 33603
Completed
34
American Clinical Trials
Acworth, Georgia, United States, 30101
Terminated
35
Wellstar Health System
Augusta, Georgia, United States, 30912
Actively Recruiting
36
Boise Kidney and Hypertension PLLC
Boise, Idaho, United States, 83706
Actively Recruiting
37
Care Institute
Chubbuck, Idaho, United States, 83202
Actively Recruiting
38
Insight Hospital & Medical Center Chicago
Chicago, Illinois, United States, 60616
Actively Recruiting
39
The University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Active, Not Recruiting
40
Indiana Nephrology
Fishers, Indiana, United States, 46037
Actively Recruiting
41
Fresenius Kidney Care Mishawaka
Mishawaka, Indiana, United States, 46545
Actively Recruiting
42
University of Iowa
Iowa City, Iowa, United States, 52242
Actively Recruiting
43
Nephrology Associates of Lexington
Lexington, Kentucky, United States, 40504
Actively Recruiting
44
LSU Health Sciences Center
Shreveport, Louisiana, United States, 71103
Actively Recruiting
45
Washington Nephrology Associates
Takoma Park, Maryland, United States, 20854
Completed
46
Holyoke Medical Center
Springfield, Massachusetts, United States, 01107
Suspended
47
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
48
Nephrology Center, PC
Kalamazoo, Michigan, United States, 49007
Actively Recruiting
49
St. Clair Nephrology Research
Roseville, Michigan, United States, 48066
Suspended
50
Southwest MS Nephrology
Brookhaven, Mississippi, United States, 39601
Actively Recruiting
51
Nephrology Associates
Columbus, Mississippi, United States, 39705
Actively Recruiting
52
Nephrology and Hypertension Associates
Tupelo, Mississippi, United States, 38801
Actively Recruiting
53
Saint Louis University
St Louis, Missouri, United States, 63110
Withdrawn
54
Nevada Kidney Disease & Hypertension Center
Las Vegas, Nevada, United States, 89052
Withdrawn
55
Seacoast Kidney & Hypertension Specialists
Portsmouth, New Hampshire, United States, 03801
Actively Recruiting
56
NYU Langone
New York, New York, United States, 10017
Actively Recruiting
57
ICAHN School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
58
Jacobi Medical Center
The Bronx, New York, United States, 10461
Actively Recruiting
59
UNC Chapel Hill
Chapel Hill, North Carolina, United States, 27514
Actively Recruiting
60
Lifespan Clinical Research Center
East Providence, Rhode Island, United States, 02915
Actively Recruiting
61
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Withdrawn
62
Dunes Clinical Research
Dakota Dunes, South Dakota, United States, 57049
Actively Recruiting
63
Knoxville Kidney Center
Knoxville, Tennessee, United States, 37923
Actively Recruiting
64
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
65
Pioneer Research Solutions, Inc.
Cypress, Texas, United States, 77429
Actively Recruiting
66
Texas Tech Health Sciences
El Paso, Texas, United States, 79905
Completed
67
Texas Tech University Health
El Paso, Texas, United States, 79905
Active, Not Recruiting
68
Plaza Nephrology
Houston, Texas, United States, 77004
Actively Recruiting
69
Biopharma Informatic, LLC
Houston, Texas, United States, 77043
Suspended
70
Prolato Clinical Research Center
Houston, Texas, United States, 77054
Actively Recruiting
71
Clinical Research Strategies, Inc
Houston, Texas, United States, 77090
Actively Recruiting
72
United Memorial Medical Center
Houston, Texas, United States, 77091
Actively Recruiting
73
Clinical Advancement Center, PLLC
San Antonio, Texas, United States, 78212
Actively Recruiting
74
University Health System
San Antonio, Texas, United States, 78229
Actively Recruiting
75
Prolato Clinical Research Center - Sugar Land
Sugar Land, Texas, United States, 77479
Actively Recruiting
76
Renal Physicians of Montgomery County
The Woodlands, Texas, United States, 77384
Actively Recruiting
77
Salem VA Medical Center
Salem, Virginia, United States, 24153
Actively Recruiting
78
Providence Medical Research Ctr
Spokane, Washington, United States, 99204
Actively Recruiting
79
University of Wisconsin-Madison
Madison, Wisconsin, United States, 53792
Actively Recruiting
80
St. George Hospital
Kogarah, New South Wales, Australia, 2217
Withdrawn
81
Lakeridge Health Corporation-Oshawa
Oshawa, Ontario, Canada
Withdrawn
82
"Ignacio Chavez" National Cardiology Institute
Tlalpan, Mexico City, Mexico, 14080
Actively Recruiting
83
National Institute of Medical Sciences and Nutrition Salvador Zubiran
Tlalpan, Mexico City, Mexico, 14080
Actively Recruiting
84
Torre Medica San Lucas
Ponce, Puerto Rico, 00716
Actively Recruiting
85
San Miguel Medical
Trujillo Alto, Puerto Rico, 00976
Actively Recruiting
86
Far Eastern Memorial Hospital
New Taipei City, Taiwan, 220
Suspended
87
Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare
New Taipei City, Taiwan, 23561
Actively Recruiting
88
China Medical University Hospital
Taichung, Taiwan, 40447
Active, Not Recruiting
89
Taichung Veterans General Hospital
Taichung, Taiwan
Actively Recruiting
90
National Taiwan University Hospital
Taipei, Taiwan, 100225
Actively Recruiting
91
Taipei Medical University Hospital
Taipei, Taiwan, 110
Actively Recruiting
92
Tri-Service General Hospital
Taipei, Taiwan, 11490
Actively Recruiting
93
Taipei Municipal Wanfang Hospital Managed by Taipei Medical University
Taipei, Taiwan, 116
Active, Not Recruiting
94
Taipei Municipal Wanfang Hospital
Taipei, Taiwan
Actively Recruiting
95
Royal London Hospital
London, United Kingdom, E1 1FR
Withdrawn
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Research Team
P
ProKidney Call Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Fortifying the Diabetic Kidney Disease Treatment Armamentarium: Multitarget Senotherapeutic and Regenerative Strategies.
Helly A Patel, Jiaxuan Wang, Caroline J Zinn...
https://pubmed.ncbi.nlm.nih.gov/40333016