Your session is about to expire
← Back to Search
Cell Therapy
REACT for Type 2 Diabetes with Chronic Kidney Disease
Phase 2
Waitlist Available
Research Sponsored by Prokidney
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
The subject has an established diagnosis of T2DM.
The subject is male or female, 30 to 80 years of age on the date of informed consent.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through 24 months following last react injection for active arm and at least 12 months following last react injection for the deferred arm
Awards & highlights
Study Summary
This trial is testing a new treatment for diabetes and kidney disease.
Who is the study for?
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%.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of Renal Autologous Cell Therapy (REACT). Participants will receive up to two REACT injections six months apart directly into their kidneys to see if it helps CKD in those with Type 2 Diabetes.See study design
What are the potential side effects?
Potential side effects are not explicitly listed but may include reactions at the injection site or complications related to the procedure since cells are injected into the kidney using a needle through the skin.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
You have been diagnosed with type 2 diabetes.
Select...
You are between 30 and 80 years old when you agree to take part in the study.
Select...
You have been diagnosed with kidney disease caused by diabetes.
Select...
You have a kidney condition with a certain level of eGFR, but you don't need dialysis yet.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through 24 months following last react injection for active arm and at least 12 months following last react injection for the deferred arm
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through 24 months following last react injection for active arm and at least 12 months following last react injection for the deferred arm
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Renal Function
Secondary outcome measures
Treatment emergent adverse events
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Immediate TreatmentExperimental Treatment1 Intervention
Renal Autologous Cell Therapy (REACT) immediate treatment - Patients who are randomized to receive their first treatment of 2 injections of REACT as soon as REACT product is made available.
Group II: Delayed TreatmentActive Control1 Intervention
Renal Autologous Cell Therapy (REACT) delayed treatment - Patients who are randomized to receive standard of care treatment for the first 12 months after REACT product is made available before receiving 2 injections of REACT.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Renal Autologous Cell Therapy (REACT)
2016
Completed Phase 2
~100
Find a Location
Who is running the clinical trial?
CTI Clinical Trial and Consulting ServicesOTHER
34 Previous Clinical Trials
3,652 Total Patients Enrolled
ProkidneyLead Sponsor
8 Previous Clinical Trials
1,360 Total Patients Enrolled
Ashley JohnsStudy DirectorProkidney
5 Previous Clinical Trials
1,269 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your kidney function has been measured at least twice, with the results taken at least 3 months apart or within the last 18 months to see how your kidney disease is progressing.Your blood pressure is lower than 150/90.Your hemoglobin levels are lower than 9 g/dL before getting each REACT injection.You have been diagnosed with kidney disease caused by diabetes.You have been diagnosed with type 1 diabetes in the past.You have been diagnosed with type 2 diabetes.You have stable blood pressure and are maintained on a stable anti-hypertensive medication regimen.Your diabetes is not well controlled and is unstable according to the doctor.You have had a kidney transplant in the past.Your HbA1c level in your blood is higher than 10%.You are between 30 and 80 years old when you agree to take part in the study.You have a kidney condition with a certain level of eGFR, but you don't need dialysis yet.
Research Study Groups:
This trial has the following groups:- Group 1: Immediate Treatment
- Group 2: Delayed Treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this clinical trial widely available in Canada?
"University of Florida in Gainesville, University of Louisville in Kentucky, and the University of Chicago Medical Center in Illinois are all participating locations in this clinical trial. Along with these 16 other medical facilities."
Answered by AI
Does this research project welcome volunteers who are octogenarians?
"The age range that is able to participate in this clinical trial as patients begins at 30 years old and concludes at 80 years old."
Answered by AI
Who would be an ideal candidate for this research?
"83 participants between the ages of 30 and 80 who have a current diagnosis of type 2 diabetes mellitus are being enrolled in this trial. Additionally, these patients must meet the following blood pressure requirements: less than 150/90 at their Screening Visit with stable blood pressure that is managed by a consistent anti-hypertensive medication regimen."
Answered by AI
What is the risk profile for REACT®?
"REACT®, or Renal Autologous Cell Therapy, is a Phase 2 clinical trial. While there is some evidence backing the safety of this intervention, more data is needed to support its efficacy."
Answered by AI
Are there currently any open slots for patients in this clinical trial?
"This particular clinical trial is not looking for new patients at the moment, however there are 1392 other trials with open recruitment. This specific study was launched on September 1st, 2016 and updated as recently as October 25th, 2022 according to information found on clinicaltrials.gov."
Answered by AI
Who else is applying?
What state do they live in?
Wisconsin
Massachusetts
Maryland
How old are they?
65+
What site did they apply to?
Yale Univeristy
University of Chicago Medical Center
Lehigh Valley Health Network
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
My Kidney Disease is getting worse.
PatientReceived no prior treatments
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger