Join Trial Studying New Treatment for Type 2 Diabetes and Chronic Kidney Disease
A trial is recruiting adults with type 2 diabetes and diabetic kidney disease to investigate an injection into the kidney that could potentially preserve kidney function. The drug has already shown promising results in a phase 2 study, especially in participants with the highest risk of kidney failure.
Trial Status: Recruiting
Clinical Trials Identifier: NCT05099770
Trial Name: A Phase 3 Randomized Controlled Study of Renal Autologous Cell Therapy (REACT) in Subjects With Type 2 Diabetes and Chronic Kidney Disease (REGEN-006)
Diabetes Type: Adults with type 2 diabetes and chronic kidney disease
Trial Sponsor: Prokidney
What is the aim of the study?
This phase 3 trial is studying the effects of Renal Autologous Cell Therapy (REACT) injections on eGFR, a measure of kidney function, in adults with a diagnosis of both type 2 diabetes and diabetic kidney disease.
Results from the phase 2 trial showed notable preservation of kidney function in participants with diabetes who had the highest risk of kidney failure. Therefore, the phase 3 protocol will focus on participants with stage 3b-4 diabetic chronic kidney disease. REACT consists of selective renal cells that can help repair kidney structure, improve function, and reduce health problems linked to chronic kidney disease.
These early phase 2 study results suggest REACT could be a potential treatment to help slow down the progression of chronic kidney disease and reduce the need for treatments like dialysis or a kidney transplant.
How does the trial work?
Participants will be assigned to either the active treatment or placebo group. The participants in the treatment group will have a kidney biopsy, followed by a REACT injection into the biopsied kidney. Twelve weeks later, participants will receive a REACT injection directly into their other kidney. The placebo group will undergo the same procedure, except no tissue will be taken during the biopsy and nothing will be injected into the kidney.
Are you interested in participating?
You may be eligible to participate if you are between 30 and 80 years of age and have:
- Type 2 diabetes
- Diabetic kidney disease
- An A1C less than 9.5% at the screening visit
- Documentation of either: eGFR 20 or higher and less than 30, not requiring renal dialysis; or an eGFR of 30 to 35 or less and uACR of 300 to 5000
- Been prescribed a blood pressure medication like an ACE inhibitor or ARB
People with type 1 diabetes or those with a history of kidney transplantation are not eligible for this study. The trial is currently recruiting in several locations throughout the U.S., Canada, Australia, Taiwan, and the U.K. See a full list of inclusion/exclusion criteria here.
Learn more about diabetes and kidney disease here: