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)
Surrogate / Intermediate Efficacy Endpoint -eGFR Slope — 18 months after the 135th participant receives their first injection / sham. 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.
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. 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
Trial sites (88)
Facility
City
Region
Status
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.
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.
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