Study of Renal Autologous Cell Therapy (REACT) in Subjects With Type 1 or 2 Diabetes and Chronic Kidney Disease (REGEN-007)

January 10, 2024 updated by: Prokidney

A Phase 2, Randomized, Open-Labeled, Repeat Dose, Safety and Efficacy Study of Renal Autologous Cell Therapy (REACT) in Subjects With Type 1 or 2 Diabetes and Chronic Kidney Disease (REGEN-007)

The purpose of this study is to assess the safety, efficacy, and durability of up to two REACT injections delivered percutaneously into biopsied and non-biopsied contralateral kidneys on renal function progression in two different cohorts of subjects with T1DM or T2DM and CKD.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The objective of this study is to assess the safety, efficacy, and durability of up to two REACT injections delivered percutaneously into biopsied and non-biopsied contralateral kidneys on renal function progression in two different cohorts of subjects with T1DM or T2DM and CKD:

  • Cohort 1: Two scheduled REACT injections given 3 months (+60 days) with at least 18- month follow-up
  • Cohort 2: One scheduled REACT injection with a possible second REACT injection, no less than 3 months after the first one, within 30 days (+30 days) of meeting a renal function redose trigger (triggered up to 15 months following the first REACT injection).

Both cohorts will be followed for 18 months after the final REACT injection. If a Cohort 2 subject does not meet a trigger, the subject will be followed for at least 18 months after the first injection.

Study Type

Interventional

Enrollment (Actual)

53

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 Contact

Study Contact Backup

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 80210-5073
        • Kidney Associates of Colorado, P.C. - Frenova
    • Delaware
      • Newark, Delaware, United States, 19713
        • Nephrology Associates
    • Idaho
      • Nampa, Idaho, United States, 83687
        • Boise Kidney and Hypertension Institute - Frenova
    • Michigan
      • Kalamazoo, Michigan, United States, 49007-3889
        • Paragon Health, PC d/b/a Nephrology Center, PC - Frenova
    • Mississippi
      • Tupelo, Mississippi, United States, 38801-6560
        • Nephrology and Hypertension Associates Ltd - Frenova

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:

  1. Male or female aged 30 to 80 years, inclusive, on the date informed consent is signed.
  2. Clinical diagnosis of T1DM or T2DM, controlled per institutional standard of care.
  3. The subject has a clinical diagnosis of diabetic nephropathy as the underlying cause of renal disease (diagnosis does not have to be confirmed via renal biopsy).
  4. The subject has a serum glycosylated hemoglobin (HbA1c) level less than 10% at the Screening Visit.
  5. The subject has a documented clinical diagnosis of an eGFR between 20 and 50 mL/min/1.73m² inclusive not requiring renal dialysis.

Exclusion Criteria:

  1. The subject has a history of renal transplantation.

  2. The subject has a mean systolic blood pressure greater than or equal to 140 mmHg and/or mean diastolic blood pressure greater than or equal to 90 mmHg at screening.

    Subjects with blood pressure outside of this range prior to biopsy/injection may continue if approved by the Medical Monitor.

  3. The subject has hemoglobin levels less than 10 g/dL and is not responsive to the standard medical intervention for CKD-related anemia prior to randomization.

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: 2 REACT injections
Cohort 1 subjects will receive 2 REACT injections in the biopsied and non-biopsied contralateral kidneys 3 months apart (+60 days).
Biological: Renal Autologous Cell Therapy (REACT)
Autologous selected renal cells (SRC)
Experimental: 1 REACT Injection
Cohort 2 subjects will receive 1 REACT injection into the biopsied kidney and if a pre-defined trigger is met, will undergo a second REACT injection into the contralateral kidney.
Biological: Renal Autologous Cell Therapy (REACT)
Autologous selected renal cells (SRC)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Improvement in renal function progression rate as indicated by the change from pre-injection baseline value in total (acute + chronic) slope of estimated glomerular filtration rate (eGFR) using the CKD-EPI 2009 equation
Time Frame: Screening thru month 28
Screening thru month 28
Procedural and investigational product-related treatment-emergent adverse events (TEAEs) obtained through 18 months after the last REACT injection.
Time Frame: Screening thru 18 months after the last injection of study drug
Screening thru 18 months after the last injection of study drug

Collaborators and Investigators

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

Sponsor

Prokidney

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)

July 27, 2021

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

September 22, 2026

Study Registration Dates

First Submitted

August 17, 2021

First Submitted That Met QC Criteria

August 18, 2021

First Posted (Actual)

August 24, 2021

Study Record Updates

Last Update Posted (Actual)

January 12, 2024

Last Update Submitted That Met QC Criteria

January 10, 2024

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REGEN-007

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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