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Cell Therapy
REACT for Type 2 Diabetes with Chronic Kidney Disease
Phase 3
Waitlist Available
Research Sponsored by Prokidney
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Are you between 30 to 80 years old?
Have you been told by a doctor that you have chronic kidney disease?
Timeline
Screening 60 days
Treatment Varies
Follow Up 30 days
Awards & highlights
Study Summary
This trial is testing a new way to treat diabetes and kidney disease by injecting a medication into the kidneys. The goal is to see if it is safe and effective.
Who is the study for?
This trial is for adults aged 30-80 with Type 2 diabetes and chronic kidney disease. It's not for those who've had a kidney transplant, have a history of kidney stones, or current hepatitis B/C, HIV, TB infections. People treated with REACT before or with Type 1 diabetes are excluded.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 injections into their kidneys three months apart to see if it helps their condition.See study design
What are the potential side effects?
Potential side effects aren't detailed here but may include reactions at the injection site, changes in blood sugar levels, and possible impacts on kidney function due to the nature of the treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
You are between the ages of 30 to 80 years old.
Select...
You've been diagnosed by a doctor for chronic kidney disease.
Select...
You've been told by a doctor that you have Type 2 diabetes
Select...
You don't have a history of Type 1 diabetes (your body cannot make insulin at all)?
Select...
You haven't had a kidney transplantation (surgery done to replace an impaired kidney with a healthy one)?
Select...
You don't have a history of kidney stones?
Select...
You currently don't have hepatitis B or C, HIV, or TB?
Select...
You are not pregnant or breastfeeding?
Select...
You did not receive treatment with REACT prior to the trial?
Timeline
Screening ~ 60 days1 visit
Treatment ~ Varies
Follow Up ~ 30 days1 visit
Screening ~ 60 days
Treatment ~ Varies
Follow Up ~30 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Primary Composite Endpoint
Secondary outcome measures
Secondary Composite Endpoint
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Cohort 2Experimental Treatment1 Intervention
Participants randomized to Cohort 2 will receive 2 injections of REACT. The second injection to occur 3 months (+30 days) after the first REACT injection.
Group II: Cohort 1Placebo Group1 Intervention
Participants randomized to Cohort 1 will receive 2 sham injections of REACT. Second injection to occur 3 months (+30 days) after the first REACT injection. Sham procedures simulate real procedure. No tissue is taken during biopsy and nothing is injected into kidney for injection.
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?
ProkidneyLead Sponsor
8 Previous Clinical Trials
843 Total Patients Enrolled
Iqvia Pty LtdIndustry Sponsor
107 Previous Clinical Trials
169,411 Total Patients Enrolled
PPDIndustry Sponsor
160 Previous Clinical Trials
36,289 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You've been told by a doctor that you have Type 2 diabetesYou are between the ages of 30 to 80 years old.You haven't had a kidney transplantation (surgery done to replace an impaired kidney with a healthy one)?You don't have a history of kidney stones?You did not receive treatment with REACT prior to the trial?You currently don't have hepatitis B or C, HIV, or TB?You've been diagnosed by a doctor for chronic kidney disease.You don't have a history of Type 1 diabetes (your body cannot make insulin at all)?You are not pregnant or breastfeeding?
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 1
- Group 2: Cohort 2
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 60 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 3 null
- Follow Ups: You may be asked to continue sharing information regarding the trial for 30 Months after you stop receiving the treatment.
Chronic Kidney Disease Patient Testimony for trial: Trial Name: NCT05099770 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the risks associated with Renal Autologous Cell Therapy?
"Renal Autologous Cell Therapy is supported by multiple rounds of clinical data, meaning it is safe."
Answered by AI
If a patient is 26 years old, would they still be able to participate in this research project?
"This trial's inclusion criteria specifies that patients must be between 30 and 80 years old in order to participate."
Answered by AI
How many dispensaries are running this trial?
"The trial is being conducted at Plaza Nephrology in Houston, Texas; Lakeridge Health Corporation-Oshawa in Oshawa, Ontario; Washington Nephrology Associates in Takoma Park, Maryland; and at 20 other locations."
Answered by AI
Who else is applying?
What state do they live in?
Tennessee
Other
California
Texas
What site did they apply to?
Plaza Nephrology
United Memorial Medical Center
Medicine and Nephrology Associates
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
0
Why did patients apply to this trial?
I would like to get treatment. Because I have type 2 diabetes. The diagnosis has me concerned.
PatientReceived 2+ prior treatments
Stage 4 kidney failure and looking for some hope. I’m trying to find a way to control my weight due to being hypoglycemic.
PatientReceived no prior treatments
What questions have other patients asked about this trial?
What does the trial entail?
PatientReceived 1 prior treatment
How responsive is this trial?
Average response time
- < 2 Days
Typically responds via
Phone Call
Email
Most responsive sites:
- Plaza Nephrology: < 24 hours
- Clinical Research Strategies, Inc: < 24 hours
- Medicine and Nephrology Associates: < 48 hours
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