Proact: A Study of REACT in Subjects With Type 2 Diabetes Mellitus and Chronic Kidney Disease
A Phase 3 Randomized Controlled Study of Renal Autologous Cell Therapy (REACT) in Subjects With Type 2 Diabetes and Chronic Kidney Disease (REGEN-006)
1 other identifier
interventional
685
4 countries
88
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 type-2-diabetes-mellitus
Started Jan 2022
Longer than P75 for phase_3 type-2-diabetes-mellitus
88 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 18, 2021
CompletedFirst Posted
Study publicly available on registry
October 29, 2021
CompletedStudy Start
First participant enrolled
January 5, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2029
August 11, 2026
August 1, 2026
7.9 years
October 18, 2021
August 10, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Surrogate / Intermediate Efficacy Endpoint -eGFR Slope
The difference in annualized eGFR slope between the rilparencel and sham cohorts (approximately 18 months after the 135th participant receives their first injection/sham) using the 2021 Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) serum creatinine-based equation.
18 months after the 135th participant receives their first injection / sham.
Clinical Endpoint
The time from first injection to the earliest of: * At least 40% reduction in eGFR, sustained for 30 days, OR * eGFR \<15 mL/min/1.73m² with corresponding two-sided 95% CI, sustained for 30 days and/or chronic dialysis, and/or kidney transplant OR * Renal or cardiovascular death
From date of first injection until the date of first event: 40% reduction in eGFR, eGFR < 15 mL/min/1.73m² and/or chronic dialysis, and or renal transplant or date of renal or cardiovascular death, whichever came first, assessed up to 94 months.
Secondary Outcomes (5)
Secondary Endpoint: Time from first injection to at least a 40% reduction in eGFR sustained for 30 days.
From date of first injection until the date of 40% reduction in eGFR assessed up to 94 months.
Secondary Endpoint: Time from first injection to eGFR < 15 mL/min/1.73m² sustained for 30 days and/or chronic dialysis, and/or kidney transplant.
From date of first injection until the date of eGFR < 15 mL/min/1.73m² assessed up to 94 months.
Secondary Endpoint: All-cause mortality.
From date of first injection to all-cause mortality assessed up to 94 months.
Secondary Endpoint: Kidney Disease Quality of Life Changes
Week 52
Secondary Endpoint: Quality of Life
Week 52
Study Arms (2)
Sham Procedure
SHAM COMPARATORParticipants randomized to the Sham Comparator arm will have 2 sham procedures.
Experimental (REACT/rilparencel injections)
EXPERIMENTALParticipants randomized to the experimental arm will receive 2 injections of REACT/ rilparencel.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- The participant is male or female, 30 to 80 years of age on the date of informed consent.
- Documented diagnosis of type 2 diabetes mellitus (T2DM) and chronic kidney disease
- Serum glycosylated hemoglobin (HbA1c) of 9.5% or lower at Screening.
- Systolic blood pressure of ≤ 140 mm Hg and diastolic blood pressure of ≤ 90 mm Hg at Screening.
- All participants should be strongly considered for treatment with sodium-glucose cotransporter 2 inhibitor (SGLT2i).
- On a clinically relevant, maximally tolerated dose of an angiotensin converting-enzyme inhibitor (ACEI) OR an angiotensin receptor blocker (ARB), unless not tolerated or contraindicated.
- Participant agrees and is able to refrain from using therapies that may increase bleeding risk for the specified pre-procedure and post-procedure durations.
- Participant is willing and able to cooperate with all aspects of the protocol and provide signed informed consent.
You may not qualify if:
- The participant has a history of type 1 diabetes mellitus.
- The participant has a history of renal transplantation or other organ transplantation
- The participant has any other known underlying cause of kidney disease
- History of acute kidney injury or major surgery within 3 months prior to the Screening Visit.
- Myocardial infarction, unstable angina, revascularization procedure or cerebrovascular accident within 12 weeks before randomization, or a revascularization procedure is planned during the trial.
- Current or history of heart failure of New York Heart Association (NYHA) Class IV cardiac disease.
- Documented clinically significant liver disease, including acute or chronic hepatitis B or hepatitis C.
- Known infection with HIV, active syphilis, or other unresolved active genitourinary infection, or active tuberculosis requiring treatment at Screening.
- Immunocompromised condition or condition requiring chronic immunosuppressive agents, including individuals treated for chronic glomerulonephritis, within 3 months of signing ICF.
- Has had a recent bleeding event or a known bleeding disorder(s) or increased risk of either thromboembolism or bleeding.
- Kidney imaging reveals contraindications for undergoing biopsy or rilparencel injection
- Maintained on any anticoagulant agents
- History of anaphylactic or severe systemic reaction(s) to blood transfusions, Dextran 40, or bovine products, or contraindication(s) to above products due to medical reasons or participant preference.
- History of severe systemic reaction(s) or any contraindication to local anesthetics or sedatives.
- Use of an investigational product or device within 12 weeks prior to Randomization or previous treatment with rilparencel.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Prokidneylead
Study Sites (88)
Nephrology Consultants
Huntsville, Alabama, 35805, United States
University of Arizona
Tucson, Arizona, 85724, United States
Amicis Research Center
Beverly Hills, California, 90211, 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
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
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
"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
Related Publications (2)
Cizman B, Butler EL, Stavas J, Prakash R, Saad T, Silva A, Wooldridge T, Aqeel A, Yan H, Barysauskas CM, Culleton B. A Randomized Clinical Trial of Kidney Autologous Cell Therapy in Diabetic Kidney Disease. Clin J Am Soc Nephrol. 2026 Jan 2;21(5):744-53. doi: 10.2215/CJN.0000000969. Online ahead of print.
PMID: 41481370DERIVEDPatel HA, Wang J, Zinn CJ, Learmonth M, Lerman LO, Wolfram J, Hickson LJ. Fortifying the Diabetic Kidney Disease Treatment Armamentarium: Multitarget Senotherapeutic and Regenerative Strategies. J Am Soc Nephrol. 2025 May 7;36(8):1655-1658. doi: 10.1681/ASN.0000000754. No abstract available.
PMID: 40333016DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
Prokidney
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 18, 2021
First Posted
October 29, 2021
Study Start
January 5, 2022
Primary Completion (Estimated)
December 1, 2029
Study Completion (Estimated)
December 1, 2029
Last Updated
August 11, 2026
Record last verified: 2026-08
Data Sharing
- IPD Sharing
- Will not share