REACT for Type 2 Diabetes with Chronic Kidney Disease
Trial Summary
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that participants should have stable blood pressure and be on a stable anti-hypertensive medication regimen, suggesting you may continue those medications.
Is the REACT treatment generally safe for humans?
How is the REACT treatment different from other treatments for type 2 diabetes with chronic kidney disease?
What is the purpose of this trial?
This trial tests a new treatment where patients with Type 2 Diabetes and Chronic Kidney Disease receive injections made from their own kidney cells to help repair kidney damage.
Research Team
Brian Johnston
Principal Investigator
CTI
Eligibility Criteria
This trial is for adults aged 30-80 with Type 2 Diabetes and Chronic Kidney Disease (CKD) not on dialysis, with an eGFR of 20-50 mL/min/1.73m². Participants must have stable blood pressure under control with medication, no history of type 1 diabetes or kidney transplants, hemoglobin levels above 9 g/dL, and HbA1c below 10%.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive up to 2 injections of REACT, either immediately or 12 months after kidney biopsy, with injections 6 months apart
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension
Participants are followed for an additional 36 months of long-term follow-up
Treatment Details
Interventions
- REACT
REACT is already approved in United States, European Union for the following indications:
- Moderate to severe diabetic kidney disease
- Moderate to severe diabetic kidney disease
Find a Clinic Near You
Who Is Running the Clinical Trial?
Prokidney
Lead Sponsor
CTI Clinical Trial and Consulting Services
Collaborator