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

August 21, 2025 updated by: Prokidney

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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. Subjects will be able to roll from Study Part 2 into a Long Term Follow-Up Master protocol for up to 5 years

Study Type

Interventional

Enrollment (Actual)

83

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85724
        • University of Arizona
    • Colorado
      • Denver, Colorado, United States, 80210
        • Kidney Associates of Colorado
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale Univeristy
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida
    • Idaho
      • Meridian, Idaho, United States, 83642
        • Boise Kidney and Hypertension Institute
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago Medical Center
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University of Louisville
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Renal Associates of Baton Rouge
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
      • Kalamazoo, Michigan, United States, 49007
        • Paragon Health
    • Mississippi
      • Tupelo, Mississippi, United States, 38801
        • Nephrology & Hypertension Associates
    • New York
      • New York, New York, United States, 45246
        • Mt. Sinai Hospital
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina- Chapel Hill
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Lehigh Valley Health Network
    • Tennessee
      • Nashville, Tennessee, United States, 37212
        • Vanderbilt University
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • University of Wisconsin-Madison

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Type 2 Diabetes Mellitus.
  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 Chronic Kidney Disease not requiring renal dialysis, defined as having an Estimated Glomerular Filtration Rate (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 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).

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 Hemoglobin A1c (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 Renal Autologous Cell Therapy (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 Renal Autologous Cell Therapy (REACT) injection.

Exclusion Criteria for Study Part 2:

1. The subject is currently receiving renal dialysis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active 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).
Other Names:
  • Rilparencel
Procedure: Renal Biopsy
a procedure in which a small sample of kidney tissue is removed
Other Names:
  • Kidney Biopsy
Active Comparator: Deferred 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).
Other Names:
  • Rilparencel
Procedure: Renal Biopsy
a procedure in which a small sample of kidney tissue is removed
Other Names:
  • Kidney Biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Renal Function
Time Frame: Through 24 months following last REACT injection for active arm and at least 12 months following last REACT injection for the deferred arm
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment emergent adverse events
Time Frame: 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
Treatment emergent adverse events, serial safety laboratory results
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prokidney

Collaborators

CTI Clinical Trial and Consulting Services

Investigators

  • Study Director: Brian Johnston, CTI

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2016

Primary Completion (Actual)

December 1, 2023

Study Completion (Actual)

December 1, 2023

Study Registration Dates

First Submitted

June 22, 2016

First Submitted That Met QC Criteria

July 18, 2016

First Posted (Estimated)

July 19, 2016

Study Record Updates

Last Update Posted (Actual)

August 24, 2025

Last Update Submitted That Met QC Criteria

August 21, 2025

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RMCL-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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