Could a kidney cell injection slow Diabetes-Related kidney failure?

NCT ID NCT05099770

Disease control Sponsor: Prokidney Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Aug 12, 2026 · Updated 3 times

Summary

This Phase 3 trial tests whether a cell therapy called REACT (rilparencel) can slow kidney decline in 685 adults with type 2 diabetes and chronic kidney disease. Participants receive either two injections of their own kidney cells or sham procedures. The study measures changes in kidney function and time to serious kidney events like dialysis or transplant.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Renal Autologous Cell Therapy (REACT/rilparencel)
What this could lead to: If successful, this could provide a new way to slow kidney function loss and delay dialysis or transplant in people with type 2 diabetes and chronic kidney disease.
What could go wrong: This is an early Phase 3 trial, so results are not yet proven. The therapy requires a kidney biopsy and two injections, which carry risks like bleeding or infection. It may not work better than sham procedures.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 685 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2022

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

30 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

chronic kidney disease chronic renal failure syndrome type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic kidney diseases Type 2 diabetes mellitus

Contacts and locations

Locations

"Ignacio Chavez" National Cardiology Institute

Tlalpan, Mexico City, 14080, Mexico
Academic Medical Research Institute

Los Angeles, California, 90022, United States
Advanced Medical Research, LLC

Lakewood, California, 90712, United States
Allameh Medical Corporation

Mission Viejo, California, 92691, United States
American Clinical Trials

Acworth, Georgia, 30101, United States
Amicis Research Center

Beverly Hills, California, 90211, United States
Biopharma Informatic, LLC

Houston, Texas, 77043, United States
Boise Kidney and Hypertension PLLC

Boise, Idaho, 83706, United States
Care Institute

Chubbuck, Idaho, 83202, United States
China Medical University Hospital

Taichung, 40447, Taiwan
Clinical Advancement Center, PLLC

San Antonio, Texas, 78212, United States
Clinical Research Strategies, Inc

Houston, Texas, 77090, United States
Dunes Clinical Research

Dakota Dunes, South Dakota, 57049, United States
Ethos Palm Beach

Loxahatchee Groves, Florida, 33470, United States
Far Eastern Memorial Hospital

New Taipei City, 220, Taiwan
Florida Kidney Physicians

Fort Lauderdale, Florida, 33316, United States
Fresenius Kidney Care Mishawaka

Mishawaka, Indiana, 46545, United States
Genesis Clinical Research

Tampa, Florida, 33603, United States
Global Clinix, LLC

Miami, Florida, 33155, United States
Golden Pacific Nephrology Medical Clinic Inc

Monterey Park, California, 91755, United States
Henry Mayo Newhall Hospital

Valencia, California, 91355, United States
Holyoke Medical Center

Springfield, Massachusetts, 01107, United States
ICAHN School of Medicine at Mount Sinai

New York, New York, 10029, United States
IMD Clinical Trials

Huntington Park, California, 90255, United States
Indiana Nephrology

Fishers, Indiana, 46037, United States
Infigo Clinical Research

Sanford, Florida, 32771, United States
Insight Hospital & Medical Center Chicago

Chicago, Illinois, 60616, United States
Integrity Medical Discovery

Pico Rivera, California, 90660, United States
Jacobi Medical Center

The Bronx, New York, 10461, United States
Kidney Consultants Medical Group

Granada Hills, California, 91344, United States
Knoxville Kidney Center

Knoxville, Tennessee, 37923, United States
LSU Health Sciences Center

Shreveport, Louisiana, 71103, United States
Lifespan Clinical Research Center

East Providence, Rhode Island, 02915, United States
Mayo Clinic

Jacksonville, Florida, 32224, United States
Medicine and Nephrology Associates

Los Alamitos, California, 90720, United States
NYU Langone

New York, New York, 10017, United States
National Institute of Clinical Research

Pomona, California, 91768, United States
National Institute of Medical Sciences and Nutrition Salvador Zubiran

Tlalpan, Mexico City, 14080, Mexico
National Taiwan University Hospital

Taipei, 100225, Taiwan
Nephrology Associates

Columbus, Mississippi, 39705, United States
Nephrology Associates Medical Group

Riverside, California, 92505, United States
Nephrology Associates PA

Newark, Delaware, 19713, United States
Nephrology Associates of Lexington

Lexington, Kentucky, 40504, United States
Nephrology Center, PC

Kalamazoo, Michigan, 49007, United States
Nephrology Consultants

Huntsville, Alabama, 35805, United States
Nephrology and Hypertension Associates

Tupelo, Mississippi, 38801, United States
New Phase Clinical Trials

Miami Beach, Florida, 33140, United States
North America Research Institute

San Dimas, California, 91773, United States
Northridge Kidney Care Center

Northridge, California, 91324, United States
Pioneer Research Solutions, Inc.

Cypress, Texas, 77429, United States
Plaza Nephrology

Houston, Texas, 77004, United States
Professional Research Center, Inc.

Miami, Florida, 33172, United States
Prolato Clinical Research Center

Houston, Texas, 77054, United States
Prolato Clinical Research Center - Sugar Land

Sugar Land, Texas, 77479, United States
Providence Medical Research Ctr

Spokane, Washington, 99204, United States
Renal Physicians of Montgomery County

The Woodlands, Texas, 77384, United States
Salem VA Medical Center

Salem, Virginia, 24153, United States
San Miguel Medical

Trujillo Alto, 00976, Puerto Rico
Seacoast Kidney & Hypertension Specialists

Portsmouth, New Hampshire, 03801, United States
South Fort Lauderdale Nephrology

Fort Lauderdale, Florida, 33316, United States
Southern California Hospital

Los Angeles, California, 90095, United States
Southwest MS Nephrology

Brookhaven, Mississippi, 39601, United States
St. Clair Nephrology Research

Roseville, Michigan, 48066, United States
Taichung Veterans General Hospital

Taichung, Taiwan
Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare

New Taipei City, 23561, Taiwan
Taipei Medical University Hospital

Taipei, 110, Taiwan
Taipei Municipal Wanfang Hospital

Taipei, Taiwan
Taipei Municipal Wanfang Hospital Managed by Taipei Medical University

Taipei, 116, Taiwan
Texas Tech Health Sciences

El Paso, Texas, 79905, United States
Texas Tech University Health

El Paso, Texas, 79905, United States
The University of Chicago Medical Center

Chicago, Illinois, 60637, United States
Torre Medica San Lucas

Ponce, 00716, Puerto Rico
Tri-Service General Hospital

Taipei, 11490, Taiwan
UC Davis Medical Group GI Unit

Sacramento, California, 95817, United States
UNC Chapel Hill

Chapel Hill, North Carolina, 27514, United States
United Memorial Medical Center

Houston, Texas, 77091, United States
University Health System

San Antonio, Texas, 78229, United States
University of Arizona

Tucson, Arizona, 85724, United States
University of Florida

Gainesville, Florida, 32608, United States
University of Iowa

Iowa City, Iowa, 52242, United States
University of Michigan

Ann Arbor, Michigan, 48109, United States
University of Wisconsin-Madison

Madison, Wisconsin, 53792, United States
Valley Clinical Trials

Northridge, California, 91325, United States
Valley Renal Medical Group

Northridge, California, 91324, United States
Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States
Washington Nephrology Associates

Takoma Park, Maryland, 20854, United States
Wellstar Health System

Augusta, Georgia, 30912, United States
West Broward Research Institute

Coral Springs, Florida, 33313, United States

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