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Assessing REACT injections for Type 2 Diabetes 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)

Phase 3 Interventional Prokidney · NCT05099770

This study is testing if REACT injections into the kidneys can help people with Type 2 diabetes and chronic kidney disease feel better and improve their health.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment685 (estimated)
Ages30 Years to 80 Years
SexAll
SponsorProkidney Industry-sponsored
Locations95 sites (Huntsville, Alabama and 94 other locations)
Trial IDNCT05099770 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of up to two REACT injections administered into the kidneys of participants with Type 2 Diabetes Mellitus (T2DM) and Chronic Kidney Disease (CKD). Participants will be randomly assigned to either receive the REACT treatment or undergo sham procedures, with follow-up extending to the global trial end date. The injections will be given three months apart, and the study aims to gather data over a maximum duration of five years to assess the durability of the treatment effects.

Who should consider this trial

Good fit: Ideal candidates include adults aged 30 to 80 with a clinical diagnosis of T2DM and diabetic nephropathy, who meet specific kidney function criteria.

Not a fit: Patients requiring renal dialysis or with HbA1c levels above 9.5% may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with T2DM and CKD, potentially improving kidney function and overall health outcomes.

How similar studies have performed: While this approach is innovative, similar studies have shown promise in using cell therapies for kidney-related conditions, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Huntsville, Alabama and 94 other locations

+45 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Type 2 Diabetes MellitusChronic Kidney DiseasesREACT®RilparencelProact
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.