A Study of Autologous Renal Autologous Cell Therapy (REACT) in Patients With Diabetic Chronic Kidney Disease

January 6, 2023 updated by: Prokidney

A Phase II, Open-Label Safety and Tolerability Study of an Renal Autologous Cell Therapy (REACT) in Patients With Type 2 Diabetes and Chronic Kidney Disease (REGEN-003)

The purpose of the present study is to assess the safety and efficacy of up to 2 injections of REACT given 6 months (+4 weeks) apart (maximum).

Study Overview

Detailed Description

All subjects enrolled will receive REACT. Subjects will receive their first REACT injection as soon as the REACT product is manufactured and shipped to the clinical site. After 6 months (+4 weeks), a second injection will be given, as appropriate. Each subject's baseline rate of renal decline, based on adequate historical clinical data obtained 24 months prior to screening visit, will serve as a comparator for monitoring the rate of progression of renal insufficiency over time.

Study Type

Interventional

Enrollment (Actual)

10

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

    • Arizona
      • Tucson, Arizona, United States, 85724
        • University of Arizona [WITHDRAWN]
    • Idaho
      • Boise, Idaho, United States, 83642
        • Boise Kidney & Hypertension Institute
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina- Chapel Hill
    • Tennessee
      • Nashville, Tennessee, United States, 37212
        • Vanderbilt University [WITHDRAWN]

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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. The subject is male or female, 30 to 65 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 14 and 20 mL/min/1.73m² inclusive at the Screening Visit and prior to REACT injection.
  5. The subject has blood pressure less than 150/90 at the Screening Visit, prior to renal biopsy, and prior to REACT injection(s). Note BP should not be significantly below the previously recorded stable pressure.
  6. A minimum of 3 measurements of eGFR or sCr should be obtained at least 3 months apart prior to the Screening Visit or within the previous 24 months to define the rate of progression of CKD. The subject should have adequate, historical clinical data to provide a reasonable estimate of the rate of progression of CKD. The Medical Monitor may be consulted to ensure there is sufficient data.

Exclusion Criteria:

  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.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Renal Autologous Cell Therapy (REACT)
Renal Autologous Cell Therapy (REACT) Treatment - Patients will receive their first treatment of 2 injections of REACT as soon as REACT product is made available.
Autologous selected renal cells (SRC)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedure and/or product related adverse events
Time Frame: Through 24 months following last REACT injection
Incidence (percentage of subjects) with procedure and/or product related adverse events by System Order Class and Preferred Term
Through 24 months following last REACT injection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Renal specific adverse events
Time Frame: Through 24 months following last REACT injection
Incidence (percentage of subjects) with renal-specific adverse events by System Order Class and Preferred Term
Through 24 months following last REACT injection

Collaborators and Investigators

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

Sponsor

Investigators

  • Study Director: Ashley Johns, Prokidney

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)

April 25, 2018

Primary Completion (Actual)

November 17, 2022

Study Completion (Actual)

November 17, 2022

Study Registration Dates

First Submitted

August 25, 2017

First Submitted That Met QC Criteria

August 31, 2017

First Posted (Actual)

September 1, 2017

Study Record Updates

Last Update Posted (Estimate)

January 9, 2023

Last Update Submitted That Met QC Criteria

January 6, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

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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