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Proact: A Study of REACT in Subjects With Type 2 Diabetes Mellitus and Chronic Kidney Disease
NCT05099770 · Prokidney
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
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)
About this study
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
Key Inclusion Criteria:
1. The participant is male or female, 30 to 80 years of age on the date of informed consent.
2. Documented diagnosis of type 2 diabetes mellitus (T2DM) and chronic kidney disease
3. Serum glycosylated hemoglobin (HbA1c) of 9.5% or lower at Screening.
4. Systolic blood pressure of ≤ 140 mm Hg and diastolic blood pressure of ≤ 90 mm Hg at Screening.
5. All participants should be strongly considered for treatment with sodium-glucose cotransporter 2 inhibitor (SGLT2i).
6. 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.
7. Participant agrees and is able to refrain from using therapies that may increase bleeding risk for the specified pre-procedure and post-procedure durations.
8. Participant is willing and able to cooperate with all aspects of the protocol and provide signed informed consent.
Key Exclusion Criteria:
1. The participant has a history of type 1 diabetes mellitus.
2. The participant has a history of renal transplantation or other organ transplantation
3. The participant has any other known underlying cause of kidney disease
4. History of acute kidney injury or major surgery within 3 months prior to the Screening Visit.
5. Myocardial infarction, unstable angina, revascularization procedure or cerebrovascular accident within 12 weeks before randomization, or a revascularization procedure is planned during the trial.
6. Current or history of heart failure of New York Heart Association (NYHA) Class IV cardiac disease.
7. History of exclusionary malignancy within the past 3 years prior to Screening
8. Documented clinically significant liver disease, including acute or chronic hepatitis B or hepatitis C.
9. Known infection with HIV, active syphilis, or other unresolved active genitourinary infection, or active tuberculosis requiring treatment at Screening.
10. Immunocompromised condition or condition requiring chronic immunosuppressive agents, including individuals treated for chronic glomerulonephritis, within 3 months of signing ICF.
11. Has had a recent bleeding event or a known bleeding disorder(s) or increased risk of either thromboembolism or bleeding.
12. Kidney imaging reveals contraindications for undergoing biopsy or rilparencel injection
13. Maintained on any anticoagulant agents
14. 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.
15. History of severe systemic reaction(s) or any contraindication to local anesthetics or sedatives.
16. Use of an investigational product or device within 12 weeks prior to Randomization or previous treatment with rilparencel.
17. Participant's health status would, in the judgement of the Investigator, be jeopardized by participating in the study.
Study design
Enrollment target: 685 participants
Allocation: randomized
Masking: triple
Age groups: adult, older_adult
Timeline
Starts: 2022-01-05
Estimated completion: 2029-12
Last updated: 2026-03-23
Interventions
Biological: Renal Autologous Cell Therapy (REACT/ rilparencel)Procedure: Sham Comparator
Primary outcomes
- • Surrogate / Intermediate Efficacy Endpoint -eGFR Slope (18 months after the 135th participant receives their first injection / sham.)
- • Clinical Endpoint (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.)
Sponsor
Prokidney · industry
Contacts & investigators
ContactProKidney Call Center · contact · proact1@careboxhealth.com · (866)955 4394
InvestigatorStudy Director · study_director, Prokidney
All locations (95)
Nephrology ConsultantsRecruiting
Huntsville, Alabama, United States
University of ArizonaRecruiting
Tucson, Arizona, United States
Amicis Research CenterActive Not Recruiting
Beverly Hills, California, United States
Paradise Clinical Research Group LLCWithdrawn
Glendora, California, United States
Kidney Consultants Medical GroupActive Not Recruiting
Granada Hills, California, United States
IMD Clinical TrialsRecruiting
Huntington Park, California, United States
Advanced Medical Research, LLCRecruiting
Lakewood, California, United States
Medicine and Nephrology AssociatesRecruiting
Los Alamitos, California, United States
Academic Medical Research InstituteRecruiting
Los Angeles, California, United States
Southern California HospitalRecruiting
Los Angeles, California, United States
Allameh Medical CorporationCompleted
Mission Viejo, California, United States
Golden Pacific Nephrology Medical Clinic IncRecruiting
Monterey Park, California, United States
Northridge Kidney Care CenterActive Not Recruiting
Northridge, California, United States
Valley Renal Medical GroupRecruiting
Northridge, California, United States
Valley Clinical TrialsRecruiting
Northridge, California, United States
Integrity Medical DiscoveryActive Not Recruiting
Pico Rivera, California, United States
National Institute of Clinical ResearchRecruiting
Pomona, California, United States
Nephrology Associates Medical GroupRecruiting
Riverside, California, United States
UC Davis Medical Group GI UnitRecruiting
Sacramento, California, United States
North America Research InstituteRecruiting
San Dimas, California, United States
Henry Mayo Newhall HospitalActive Not Recruiting
Valencia, California, United States
Nephrology Associates PARecruiting
Newark, Delaware, United States
West Broward Research InstituteActive Not Recruiting
Coral Springs, Florida, United States
Florida Kidney PhysiciansCompleted
Fort Lauderdale, Florida, United States
South Fort Lauderdale NephrologyRecruiting
Fort Lauderdale, Florida, United States
University of FloridaRecruiting
Gainesville, Florida, United States
Mayo ClinicRecruiting
Jacksonville, Florida, United States
Ethos Palm BeachRecruiting
Loxahatchee Groves, Florida, United States
Global Clinix, LLCRecruiting
Miami, Florida, United States
Professional Research Center, Inc.Recruiting
Miami, Florida, United States
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Miami Beach, Florida, United States
Infigo Clinical ResearchRecruiting
Sanford, Florida, United States
Genesis Clinical ResearchCompleted
Tampa, Florida, United States
American Clinical TrialsTerminated
Acworth, Georgia, United States
Wellstar Health SystemRecruiting
Augusta, Georgia, United States
Boise Kidney and Hypertension PLLCRecruiting
Boise, Idaho, United States
Care InstituteRecruiting
Chubbuck, Idaho, United States
Insight Hospital & Medical Center ChicagoRecruiting
Chicago, Illinois, United States
The University of Chicago Medical CenterActive Not Recruiting
Chicago, Illinois, United States
Indiana NephrologyRecruiting
Fishers, Indiana, United States
Fresenius Kidney Care MishawakaRecruiting
Mishawaka, Indiana, United States
University of IowaRecruiting
Iowa City, Iowa, United States
Nephrology Associates of LexingtonRecruiting
Lexington, Kentucky, United States
LSU Health Sciences CenterRecruiting
Shreveport, Louisiana, United States
Washington Nephrology AssociatesCompleted
Takoma Park, Maryland, United States
Holyoke Medical CenterSuspended
Springfield, Massachusetts, United States
University of MichiganRecruiting
Ann Arbor, Michigan, United States
Nephrology Center, PCRecruiting
Kalamazoo, Michigan, United States
St. Clair Nephrology ResearchSuspended
Roseville, Michigan, United States
Southwest MS NephrologyRecruiting
Brookhaven, Mississippi, United States
Nephrology AssociatesRecruiting
Columbus, Mississippi, United States
Nephrology and Hypertension AssociatesRecruiting
Tupelo, Mississippi, United States
Saint Louis UniversityWithdrawn
St Louis, Missouri, United States
Nevada Kidney Disease & Hypertension CenterWithdrawn
Las Vegas, Nevada, United States
Seacoast Kidney & Hypertension SpecialistsRecruiting
Portsmouth, New Hampshire, United States
NYU LangoneRecruiting
New York, New York, United States
ICAHN School of Medicine at Mount SinaiRecruiting
New York, New York, United States
Jacobi Medical CenterRecruiting
The Bronx, New York, United States
UNC Chapel HillRecruiting
Chapel Hill, North Carolina, United States
Lifespan Clinical Research CenterRecruiting
East Providence, Rhode Island, United States
Rhode Island HospitalWithdrawn
Providence, Rhode Island, United States
Dunes Clinical ResearchRecruiting
Dakota Dunes, South Dakota, United States
Knoxville Kidney CenterRecruiting
Knoxville, Tennessee, United States
Vanderbilt University Medical CenterRecruiting
Nashville, Tennessee, United States
Pioneer Research Solutions, Inc.Recruiting
Cypress, Texas, United States
Texas Tech Health SciencesCompleted
El Paso, Texas, United States
Texas Tech University HealthActive Not Recruiting
El Paso, Texas, United States
Plaza NephrologyRecruiting
Houston, Texas, United States
Biopharma Informatic, LLCSuspended
Houston, Texas, United States
Prolato Clinical Research CenterRecruiting
Houston, Texas, United States
Clinical Research Strategies, IncRecruiting
Houston, Texas, United States
United Memorial Medical CenterRecruiting
Houston, Texas, United States
Clinical Advancement Center, PLLCRecruiting
San Antonio, Texas, United States
University Health SystemRecruiting
San Antonio, Texas, United States
Prolato Clinical Research Center - Sugar LandRecruiting
Sugar Land, Texas, United States
Renal Physicians of Montgomery CountyRecruiting
The Woodlands, Texas, United States
Salem VA Medical CenterRecruiting
Salem, Virginia, United States
Providence Medical Research CtrRecruiting
Spokane, Washington, United States
University of Wisconsin-MadisonRecruiting
Madison, Wisconsin, United States
St. George HospitalWithdrawn
Kogarah, New South Wales, Australia
Lakeridge Health Corporation-OshawaWithdrawn
Oshawa, Ontario, Canada
"Ignacio Chavez" National Cardiology InstituteRecruiting
Tlalpan, Mexico City, Mexico
National Institute of Medical Sciences and Nutrition Salvador ZubiranRecruiting
Tlalpan, Mexico City, Mexico
Torre Medica San LucasRecruiting
Ponce, Puerto Rico
San Miguel MedicalRecruiting
Trujillo Alto, Puerto Rico
Far Eastern Memorial HospitalSuspended
New Taipei City, Taiwan
Taipei Medical University - Shuang Ho Hospital, Ministry of Health and WelfareRecruiting
New Taipei City, Taiwan
China Medical University HospitalActive Not Recruiting
Taichung, Taiwan
Taichung Veterans General HospitalRecruiting
Taichung, Taiwan
National Taiwan University HospitalRecruiting
Taipei, Taiwan
Taipei Medical University HospitalRecruiting
Taipei, Taiwan
Tri-Service General HospitalRecruiting
Taipei, Taiwan
Taipei Municipal Wanfang Hospital Managed by Taipei Medical UniversityActive Not Recruiting
Taipei, Taiwan
Taipei Municipal Wanfang HospitalRecruiting
Taipei, Taiwan
Royal London HospitalWithdrawn
London, United Kingdom