A Study of Renal Autologous Cell Therapy (REACT) in Type 2 Diabetics With Chronic Kidney Disease
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
1 other identifier
interventional
83
1 country
16
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 Type 2 Diabetes Mellitus (T2DM) and Chronic Kidney Disease (CKD).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 type-2-diabetes-mellitus
Started Sep 2016
Longer than P75 for phase_2 type-2-diabetes-mellitus
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 22, 2016
CompletedFirst Posted
Study publicly available on registry
July 19, 2016
CompletedStudy Start
First participant enrolled
September 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedAugust 24, 2025
October 1, 2024
7.3 years
June 22, 2016
August 21, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Renal Function
Serial measurements of estimated glomerular filtration rate (eGFR) obtained pre-randomization and at three-month intervals through 24 months after the last REACT injection in the active treatment group and at least 12 months post last REACT injection in the deferred treatment group.
Through 24 months following last REACT injection for active arm and at least 12 months following last REACT injection for the deferred arm
Secondary Outcomes (1)
Treatment emergent adverse events
Through 24 months following last REACT injection for the active arm and at least 12 months following the last REACT injection for the deferred arm
Study Arms (2)
Active Treatment
EXPERIMENTALRenal 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.
Deferred Treatment
ACTIVE COMPARATORRenal 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.
Interventions
Autologous selected renal cells (SRC).
a procedure in which a small sample of kidney tissue is removed
Eligibility Criteria
You may qualify if:
- 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 Type 2 Diabetes Mellitus.
- The subject has an established diagnosis of diabetic nephropathy as the underlying cause of renal disease.
- The subject has an established diagnosis of Chronic Kidney Disease not requiring renal dialysis, defined as having an Estimated Glomerular Filtration Rate (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 Estimated Glomerular Filtration Rate (eGFR) or serum creatine ratio (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 Chronic Kidney Disease (CKD).
You may not qualify if:
- The subject has a history of type 1 diabetes mellitus.
- The subject has a history of renal transplantation.
- The subject has a serum Hemoglobin A1c (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 Renal Autologous Cell Therapy (REACT) injection.
- 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 Renal Autologous Cell Therapy (REACT) injection.
- \. The subject is currently receiving renal dialysis.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Prokidneylead
- CTI Clinical Trial and Consulting Servicescollaborator
Study Sites (16)
University of Arizona
Tucson, Arizona, 85724, United States
Kidney Associates of Colorado
Denver, Colorado, 80210, United States
Yale Univeristy
New Haven, Connecticut, 06520, United States
University of Florida
Gainesville, Florida, 32610, United States
Boise Kidney and Hypertension Institute
Meridian, Idaho, 83642, United States
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
University of Louisville
Louisville, Kentucky, 40202, United States
Renal Associates of Baton Rouge
Baton Rouge, Louisiana, 70808, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Paragon Health
Kalamazoo, Michigan, 49007, United States
Nephrology & Hypertension Associates
Tupelo, Mississippi, 38801, United States
Mt. Sinai Hospital
New York, New York, 45246, United States
University of North Carolina- Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Lehigh Valley Health Network
Allentown, Pennsylvania, 18103, United States
Vanderbilt University
Nashville, Tennessee, 37212, United States
University of Wisconsin-Madison
Madison, Wisconsin, 53705, United States
Related Publications (1)
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.
PMID: 35034024DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Brian Johnston
CTI
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 22, 2016
First Posted
July 19, 2016
Study Start
September 1, 2016
Primary Completion
December 1, 2023
Study Completion
December 1, 2023
Last Updated
August 24, 2025
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share