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Clinical Trials in the USA / NCT05099770
Active, not recruiting Phase 3

Proact: A Study of REACT in Subjects With Type 2 Diabetes Mellitus and Chronic Kidney Disease

NCT05099770 · tracked via the Priya Life Science USA tracker
Sponsor
Prokidney
Phase
Phase 3
Started
2022-01-05
Last updated
2026-08-11

Condition(s) studied

Type 2 Diabetes MellitusChronic Kidney Diseases

Investigational drug(s) / intervention(s)

Renal Autologous Cell Therapy (REACT/ rilparencel)Sham Comparator

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.

Study 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.

Eligibility

Sex
ALL
Min age
30 Years
Max age
80 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (88)

FacilityCityRegionStatus
Nephrology Consultants Huntsville Alabama
University of Arizona Tucson Arizona
Amicis Research Center Beverly Hills California
Kidney Consultants Medical Group Granada Hills California
IMD Clinical Trials Huntington Park California
Advanced Medical Research, LLC Lakewood California
Medicine and Nephrology Associates Los Alamitos California
Academic Medical Research Institute Los Angeles California
Southern California Hospital Los Angeles California
Allameh Medical Corporation Mission Viejo California
Golden Pacific Nephrology Medical Clinic Inc Monterey Park California
Northridge Kidney Care Center Northridge California
Valley Renal Medical Group Northridge California
Valley Clinical Trials Northridge California
Integrity Medical Discovery Pico Rivera California
National Institute of Clinical Research Pomona California
Nephrology Associates Medical Group Riverside California
UC Davis Medical Group GI Unit Sacramento California
North America Research Institute San Dimas California
Henry Mayo Newhall Hospital Valencia California
Nephrology Associates PA Newark Delaware
West Broward Research Institute Coral Springs Florida
Florida Kidney Physicians Fort Lauderdale Florida
South Fort Lauderdale Nephrology Fort Lauderdale Florida
University of Florida Gainesville Florida
Mayo Clinic Jacksonville Florida
Ethos Palm Beach Loxahatchee Groves Florida
Global Clinix, LLC Miami Florida
Professional Research Center, Inc. Miami Florida
New Phase Clinical Trials Miami Beach Florida
Infigo Clinical Research Sanford Florida
Genesis Clinical Research Tampa Florida
American Clinical Trials Acworth Georgia
Wellstar Health System Augusta Georgia
Boise Kidney and Hypertension PLLC Boise Idaho
Care Institute Chubbuck Idaho
Insight Hospital & Medical Center Chicago Chicago Illinois
The University of Chicago Medical Center Chicago Illinois
Indiana Nephrology Fishers Indiana
Fresenius Kidney Care Mishawaka Mishawaka Indiana

+ 48 more sites — see the full list on the official registry below.

More Prokidney trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05099770 on ClinicalTrials.gov ↗ ← All trials in the USA