This trial is not actively recruiting.

This trial has completed recruitment on this platform, and is no longer accepting new referrals.

A Trial to Evaluate an Investigational Drug called “REACT” as Treatment for People with Type 2 Diabetes and Chronic Kidney Disease

Trial ID: NCT05099770
More than 500,000 patients deal with diabetic kidney disease every year in the United States. This diabetic kidney disease clinical trial will see if the investigational product is safe and whether it works to improve function in kidneys damaged by type 2 diabetes mellitus.

About the Trial

About the Trial

This trial will include adults with Type 2 diabetes and CKD. Researchers want to see whether REACT helps to improve kidney function in these participants. They also want to learn about any medical issues the participants might have during treatment in the trial.

Participants will be randomly assigned to get either REACT injections or ‘sham REACT injections’ (sham REACT injections are simulated REACT injections, but they do not have active ingredients in them, and nothing will be injected or touch your kidneys). Half of the participants will receive REACT injections and the other half will receive sham injections. During the trial, neither the participants nor the trial site staff will know who is receiving the REACT injections and sham injections. Researchers use this method because knowing what treatment a participant is receiving can affect the results.

Estimated Enrollment

About 600 Participants

Phase

3

Eligibility Criteria

What patients are eligible for this diabetic kidney disease study? The proact study is looking for individuals who fit these as well as other eligibility criteria as determined during screening processes:

Participants must:

Inclusion Criteria

Participants must

  • Be between 30 and 80 years of age.
  • Have been diagnosed with Type 2 diabetes mellitus and chronic kidney disease.
  • Do not currently need renal dialysis for treatment.

Participants must not:

Exclusion Criteria

Participants must not

  • Have been diagnosed with or have a history of Type 1 diabetes.
  • Have a history of kidney transplantation (surgery done to replace an impaired kidney with a healthy one).
  • Have a history of kidney stones.
  • Have active hepatitis B or C, HIV, or tuberculosis (TB).
  • Be pregnant or breastfeeding.
  • Have received treatment with REACT prior to the trial.

About the Condition and the Study

The kidneys are an important part of the body. The kidneys get rid of the body’s waste products (for example, urine). Kidney disease can lead to kidney function weakening or failure. Chronic kidney failure means that the kidneys’ ability to filter the blood and regulate water in the body is impaired. Chronic kidney failure develops gradually, and the disease is incurable at late stages.

In this trial, researchers wanted to study about an investigational product called “Renal Autologous Cell Therapy” (also called REACT) in people with Type 2 diabetes and chronic kidney disease (CKD). REACT is a product that is made by using a person’s own kidney cells, which are taken by inserting a small needle into the kidney (also called “biopsy”).

What Will Happen in This Study

If you are interested in joining this trial, you will need to visit a clinical trial site. A doctor will explain the trial to you. If you agree to join, the doctors and other trial staff will ask you questions and run some medical tests to make sure you are eligible.

If you meet all qualifications, you will be assigned to be in 1 of the 2 trial groups:

  • Group 1: If you are assigned to Group 1, you will get 2 sham REACT injections.
  • Group 2: If you are assigned to Group 2, you will get 2 REACT injections.

Since REACT is made from your own kidney cells, you will have to undergo a biopsy (‘simulated’ or sham if you are in Group 1, and real if you are in Group 2) prior to treatment. The first injection will be given about 12 weeks (about 3 months) after the biopsy. The 2 injection procedures, regardless of the group you are in, will be given about 3 months apart. If you are in group 1, the ‘simulated’ or sham injection procedures are similar to the REACT injections, but nothing will be injected or touch your kidneys. If you are in Group 2, the injections will be given through a passageway from the skin to the kidney. You will be asked to stay at the hospital on the day of your biopsy and injections.

What Will Happen in This Study More

You will be asked to do scheduled trial site visits throughout the treatment period. During these trial visits, the trial doctors will run tests and ask questions that will help them monitor your CKD and keep track of your general health.

After completing your injections, you will be asked to return to the trial site about every 3 months until the trial ends so trial doctors can continue to monitor your health.

In total, all participants will be in the study for about 60 months (about 5 years).

Details about these visits and the types of tests and procedures that will be performed will be explained to you fully before you decide whether you want to join the trial.

What can you do next?

  1. Complete the prescreen questionnaire on this website
  2. Select a study site
  3. Share contact information with the study site coordinator
  4. Make contact and respond to the study site coordinator that you selected
  5. Share the NCT Identifier Number with your doctor: NCT05099770

Travel Support

People who qualify and choose to join may be compensated for study-related time and reimbursed for travel expenses. Costs for REACT, health assessments, and medical tests related to the Proact study will be provided to patients at no cost. Travel and accommodation arrangements are available to participants. Please speak to the study doctor for more information.

Where You Can Join

You will need to travel to one of the study clinics taking part in this clinical trial. Sites are located in:

Location
University of Florida - Division of Nephrology, Hypertension, Renal Transplantation
Status
Recruiting
Location
AMR - Medicine & Nephrology Associates
Status
Recruiting
Location
University of Michigan Medical Center - Nephrology
Status
Not yet Recruiting
Location
Clinical Research Strategies, Inc.
Status
Not yet Recruiting
Location
Texas Tech University Health Sciences Center - El Paso - Department of Internal Medicine
Status
Not yet Recruiting
Location
St Clair Nephrology Research, LLC
Status
Not yet Recruiting
Location
Renal and Transplant Associates of New England, PC
Status
Not yet Recruiting
Location
Paradise Clinical Research Group LLC
Status
Not yet Recruiting
Location
Academic Medical Research Institute
Status
Not yet Recruiting
Location
Premier Renal Clinic
Status
Not yet Recruiting
Location
Dunes Clinical Research
Status
Not yet Recruiting
Location
North America Research Institute
Status
Not yet Recruiting
Location
Biopharma Informatic, Inc, Research Center
Status
Recruiting
Location
CaRe Institute
Status
Recruiting
Location
Washington Nephrology Associates
Status
Recruiting
Location
The University of Iowa - Institute for Clinical and Translational Science
Status
Not yet Recruiting
Location
Seacoast Kidney & Hypertension Specialists
Status
Not yet Recruiting
Location
United Memorial Medical Center
Status
Recruiting
Location
Nevada Kidney Disease & Hypertension Centers
Status
Recruiting
Location
Innovative Healthcare Institute, LLC
Status
Not yet Recruiting
Location
IMD Clinical Trials - Victor G. Carabello, MD
Status
Recruiting
Location
Genesis Trials Clinical Research
Status
Not yet Recruiting
Location
New Phase Clinical Trials Corp
Status
Recruiting
Location
aQua Research Institute, LLC
Status
Not yet Recruiting
Location
Voyage Medical
Status
Not yet Recruiting
Location
UNC Hospitals
Status
Recruiting
Location
UC Davis - Clinical Translational Science Center
Status
Not yet Recruiting
Location
Valley Clinical Trials
Status
Recruiting
Location
Knoxville Kidney Center
Status
Recruiting
Location
Insight Hospital & Medical Center Chicago
Status
Not yet Recruiting
Location
Boise Kidney & Hypertension PLLC
Status
Not yet Recruiting
Location
Lifespan Clinical Research - Rhode Island Hospital
Status
Recruiting
Location
IMD Clinical Trials - Dr. Minou Tran
Status
Recruiting
Location
University of Chicago Medical Center - Nephrology
Status
Recruiting

See if You are Eligible

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