Back to resultsA Study of Renal Autologous Cell Therapy (REACT) in Type 2 Diabetics With Chronic Kidney Disease
Primary Purpose
Type 2 Diabetes Mellitus, Chronic Kidney Disease
Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Renal Autologous Cell Therapy (REACT)
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus
Eligibility Criteria
Inclusion Criteria for Study Part 1:
- The subject is male or female, 30 to 80 years of age on the date of informed consent.
- The subject has an established diagnosis of T2DM.
- The subject has an established diagnosis of diabetic nephropathy as the underlying cause of renal disease.
- 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.
- The subject has blood pressure less than 150/90 at the Screening Visit.
- The subject has stable blood pressure and is maintained on a stable anti-hypertensive medication regimen.
- 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:
- The subject has a history of type 1 diabetes mellitus.
- The subject has a history of renal transplantation.
- The subject has a serum HbA1c level greater than 10% at the Screening Visit.
- The subject has uncontrolled diabetes (defined as metabolically unstable by the Investigator).
- The subject has hemoglobin levels less than 9 g/dL prior to each REACT injection.
Inclusion Criteria for Study Part 2:
- The subject is willing and able to provide signed informed consent.
- 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.
Sites / Locations
- University of Arizona
- Kidney Associates of Colorado
- Yale Univeristy
- University of Florida
- Boise Kidney and Hypertension Institute
- University of Chicago Medical Center
- University of Louisville
- Renal Associates of Baton Rouge
- University of Michigan
- Paragon Health
- Nephrology & Hypertension Associates
- Mt. Sinai Hospital
- University of North Carolina- Chapel Hill
- Lehigh Valley Health Network
- Vanderbilt University
- University of Wisconsin-Madison
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Immediate Treatment
Delayed Treatment
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Change in Renal Function
eGFR at 24 months after last REACT injection
Secondary Outcome Measures
Treatment emergent adverse events
Treatment emergent adverse events, serial safety laboratory results
Full Information
NCT ID
NCT02836574
First Posted
June 22, 2016
Last Updated
January 6, 2023
Sponsor
Prokidney
Collaborators
CTI Clinical Trial and Consulting Services
1. Study Identification
Unique Protocol Identification Number
NCT02836574
Brief Title
A Study of Renal Autologous Cell Therapy (REACT) in Type 2 Diabetics With Chronic Kidney Disease
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 Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 2016 (undefined)
Primary Completion Date
May 2025 (Anticipated)
Study Completion Date
May 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Prokidney
Collaborators
CTI Clinical Trial and Consulting Services
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus, Chronic Kidney Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
83 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Immediate Treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
Delayed Treatment
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Renal Autologous Cell Therapy (REACT)
Intervention Description
Autologous selected renal cells (SRC).
Primary Outcome Measure Information:
Title
Change in Renal Function
Description
eGFR at 24 months after last REACT injection
Time Frame
Through 24 months following last REACT injection
Secondary Outcome Measure Information:
Title
Treatment emergent adverse events
Description
Treatment emergent adverse events, serial safety laboratory results
Time Frame
Through 24 months following last REACT injection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria for Study Part 1:
The subject is male or female, 30 to 80 years of age on the date of informed consent.
The subject has an established diagnosis of T2DM.
The subject has an established diagnosis of diabetic nephropathy as the underlying cause of renal disease.
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.
The subject has blood pressure less than 150/90 at the Screening Visit.
The subject has stable blood pressure and is maintained on a stable anti-hypertensive medication regimen.
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:
The subject has a history of type 1 diabetes mellitus.
The subject has a history of renal transplantation.
The subject has a serum HbA1c level greater than 10% at the Screening Visit.
The subject has uncontrolled diabetes (defined as metabolically unstable by the Investigator).
The subject has hemoglobin levels less than 9 g/dL prior to each REACT injection.
Inclusion Criteria for Study Part 2:
The subject is willing and able to provide signed informed consent.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashley Johns
Organizational Affiliation
Prokidney
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Brian Johnston
Organizational Affiliation
CTI
Official's Role
Study Director
Facility Information:
Facility Name
University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Kidney Associates of Colorado
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
Country
United States
Facility Name
Yale Univeristy
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Boise Kidney and Hypertension Institute
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Renal Associates of Baton Rouge
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Paragon Health
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007
Country
United States
Facility Name
Nephrology & Hypertension Associates
City
Tupelo
State/Province
Mississippi
ZIP/Postal Code
38801
Country
United States
Facility Name
Mt. Sinai Hospital
City
New York
State/Province
New York
ZIP/Postal Code
45246
Country
United States
Facility Name
University of North Carolina- Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Lehigh Valley Health Network
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Facility Name
University of Wisconsin-Madison
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35034024
Citation
Stavas J, Gerber D, Coca SG, Silva AL, Johns A, Jain D, Bertram T, Diaz-Gonzalez de Ferris M, Bakris G. Novel Renal Autologous Cell Therapy for Type 2 Diabetes Mellitus Chronic Diabetic Kidney Disease: Clinical Trial Design. Am J Nephrol. 2022;53(1):50-58. doi: 10.1159/000520231. Epub 2022 Jan 14.
Results Reference
derived
Learn more about this trial
A Study of Renal Autologous Cell Therapy (REACT) in Type 2 Diabetics With Chronic Kidney Disease
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