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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 : February 15, 2022
Sponsor:
Collaborator:
CTI Clinical Trial and Consulting Services
Information provided by (Responsible Party):
Prokidney

Tracking Information
First Submitted Date  ICMJE June 22, 2016
First Posted Date  ICMJE July 19, 2016
Last Update Posted Date February 15, 2022
Study Start Date  ICMJE September 2016
Estimated Primary Completion Date May 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 3, 2022)
Change in Renal Function [ Time Frame: Through 24 months following last REACT® injection ]
eGFR at 24 months after last REACT® injection
Original Primary Outcome Measures  ICMJE
 (submitted: July 18, 2016)
Change in Renal Function [ Time Frame: Through 12 months following last NKA injection ]
eGFR at 12 months after last NKA injection
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 3, 2022)
Treatment emergent adverse events [ Time Frame: Through 24 months following last REACT® injection ]
Treatment emergent adverse events, serial safety laboratory results
Original Secondary Outcome Measures  ICMJE
 (submitted: July 18, 2016)
Treatment emergent adverse events [ Time Frame: Through 12 months following last NKA injection ]
Treatment emergent adverse events, serial safety laboratory results
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Renal Autologous Cell Therapy (REACT®) in Type 2 Diabetics With Chronic Kidney Disease
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Type 2 Diabetes Mellitus
  • Chronic Kidney Disease
Intervention  ICMJE Biological: Renal Autologous Cell Therapy (REACT®)
Autologous selected renal cells (SRC).
Study Arms  ICMJE
  • 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.
    Intervention: Biological: Renal Autologous Cell Therapy (REACT®)
  • 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®.
    Intervention: Biological: Renal Autologous Cell Therapy (REACT®)
Publications * Stavas J, Gerber D, Coca SG, Silva AL, Johns A, Jain D, Bertram T, Díaz-González 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: November 23, 2020)
83
Original Estimated Enrollment  ICMJE
 (submitted: July 18, 2016)
50
Estimated Study Completion Date  ICMJE May 2028
Estimated Primary Completion Date May 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries Cayman Islands
 
Administrative Information
NCT Number  ICMJE NCT02836574
Other Study ID Numbers  ICMJE RMCL-002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Prokidney
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Prokidney
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE CTI Clinical Trial and Consulting Services
Investigators  ICMJE
Study Director: Ashley Johns Prokidney
Study Director: Brian Johnston CTI
PRS Account Prokidney
Verification Date February 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP