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A Study of Renal Autologous Cell Therapy™ (REACT) in Type 2 Diabetics With Chronic Kidney Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02836574
Recruitment Status : Active, not recruiting
First Posted : July 19, 2016
Last Update Posted : January 21, 2022
Sponsor:
Collaborator:
CTI Clinical Trial and Consulting Services
Information provided by (Responsible Party):
Prokidney

Brief Summary:
To assess the safety and efficacy of up to two REACT injections given 6 months (+4 weeks) apart and delivered into the biopsied kidney using a percutaneous approach in participants with T2DM and CKD.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Chronic Kidney Disease Biological: Renal Autologous Cell Therapy (REACT) Phase 2

Detailed Description:

Study Part 1: Multi-center, prospective, open-label, randomized, double-arm, deferred treatment study whereby eligible subjects will be randomized 1:1 after kidney biopsy to receive up to 2 injections of REACT (made from expanded autologous selected renal cells) into the biopsied kidney beginning as soon as REACT can be prepared, or the same series of up to 2 injections given 6 months (+4 weeks) apart beginning 12 months after renal biopsy. Subjects will be followed through 23 months after the last injection.

Study Part 2: An open-label extension study in which eligible subjects will be followed for an additional 36 months of long-term follow-up.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 83 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Prospective, Randomized, Double-Arm, Deferred Treatment, Open Label, Repeat Dose, Safety and Efficacy Study of Renal Autologous Cell Therapy™ (REACT) in Subjects With Type 2 Diabetes and Chronic Kidney Disease
Study Start Date : September 2016
Estimated Primary Completion Date : May 2025
Estimated Study Completion Date : May 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Experimental: Immediate Treatment
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.
Biological: Renal Autologous Cell Therapy (REACT)
Autologous selected renal cells (SRC).

Active Comparator: Delayed Treatment
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.
Biological: Renal Autologous Cell Therapy (REACT)
Autologous selected renal cells (SRC).




Primary Outcome Measures :
  1. Change in Renal Function [ Time Frame: Through 24 months following last REACT injection ]
    eGFR at 24 months after last REACT injection


Secondary Outcome Measures :
  1. Treatment emergent adverse events [ Time Frame: Through 24 months following last REACT injection ]
    Treatment emergent adverse events, serial safety laboratory results



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria for Study Part 1:

  1. The subject is male or female, 30 to 80 years of age on the date of informed consent.
  2. The subject has an established diagnosis of T2DM.
  3. The subject has an established diagnosis of diabetic nephropathy as the underlying cause of renal disease.
  4. The subject has an established diagnosis of CKD not requiring renal dialysis, defined as having an eGFR between 20 and 50 mL/min/1.73m².
  5. The subject has blood pressure less than 150/90 at the Screening Visit.
  6. The subject has stable blood pressure and is maintained on a stable anti-hypertensive medication regimen.
  7. A minimum of 2 measurements of eGFR or sCr should be obtained at least 3 months apart prior to the Screening Visit or within the previous 18 months to define the rate of progression of CKD.

Exclusion Criteria for Study Part 1:

  1. The subject has a history of type 1 diabetes mellitus.
  2. The subject has a history of renal transplantation.
  3. The subject has a serum HbA1c level greater than 10% at the Screening Visit.
  4. The subject has uncontrolled diabetes (defined as metabolically unstable by the Investigator).
  5. The subject has hemoglobin levels less than 9 g/dL prior to each REACT injection.

Inclusion Criteria for Study Part 2:

  1. The subject is willing and able to provide signed informed consent.
  2. The subject was enrolled into Part 1 of the study and received at least one REACT injection.

Exclusion Criteria for Study Part 2:

1. The subject is currently receiving renal dialysis.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02836574


Locations
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United States, Arizona
University of Arizona
Tucson, Arizona, United States, 85724
United States, Colorado
Kidney Associates of Colorado
Denver, Colorado, United States, 80210
United States, Connecticut
Yale Univeristy
New Haven, Connecticut, United States, 06520
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
United States, Idaho
Boise Kidney and Hypertension Institute
Meridian, Idaho, United States, 83642
United States, Illinois
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
United States, Kentucky
University of Louisville
Louisville, Kentucky, United States, 40202
United States, Louisiana
Renal Associates of Baton Rouge
Baton Rouge, Louisiana, United States, 70808
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Paragon Health
Kalamazoo, Michigan, United States, 49007
United States, Mississippi
Nephrology & Hypertension Associates
Tupelo, Mississippi, United States, 38801
United States, New York
Mt. Sinai Hospital
New York, New York, United States, 45246
United States, North Carolina
University of North Carolina- Chapel Hill
Chapel Hill, North Carolina, United States, 27599
United States, Pennsylvania
Lehigh Valley Health Network
Allentown, Pennsylvania, United States, 18103
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37212
United States, Wisconsin
University of Wisconsin-Madison
Madison, Wisconsin, United States, 53705
Sponsors and Collaborators
Prokidney
CTI Clinical Trial and Consulting Services
Investigators
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Study Director: Ashley Johns Prokidney
Study Director: Brian Johnston CTI
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Responsible Party: Prokidney
ClinicalTrials.gov Identifier: NCT02836574    
Other Study ID Numbers: RMCL-002
First Posted: July 19, 2016    Key Record Dates
Last Update Posted: January 21, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Renal Insufficiency