A Study of REACT in Subjects With Type 2 Diabetes Mellitus and Chronic Kidney Disease

March 12, 2024 updated by: Prokidney

A Phase 3 Randomized Controlled Study of Renal Autologous Cell Therapy (REACT) in Subjects With Type 2 Diabetes and Chronic Kidney Disease (REGEN-006)

The purpose of this study is to assess the safety and efficacy (including durability) of up to 2 REACT injections given 3 months (+30 days) apart and delivered percutaneously into biopsied and non-biopsied contralateral kidneys in participants with T2DM and CKD.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Randomized multi-center, blinded intervention, two cohort, study whereby eligible participants will be randomized 1:1, prior to kidney biopsy, to 1 of 2 cohorts. Cohort 1 participants will undergo sham procedures and be followed to the global trial end date. Cohort 2 participants will receive 2 REACT injections 3 months apart (+30 days) and be followed to the global trial end date. This event driven study is estimated to have a total maximum duration of 5 years.

Study Type

Interventional

Enrollment (Estimated)

600

Phase

  • Phase 3

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

  • Australia
    • New South Wales
      • Kogarah, New South Wales, Australia, 2217
        • St. George Hospital
  • Canada
    • Ontario
      • Oshawa, Ontario, Canada
        • Lakeridge Health Corporation-Oshawa
  • Taiwan
      • New Taipei City, Taiwan, 220
        • Far Eastern Memorial Hospital
      • New Taipei City, Taiwan, 23561
        • Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare
      • Taichung, Taiwan, 40447
        • China Medical University Hospital
      • Taipei, Taiwan, 11490
        • Tri-Service General Hospital
      • Taipei, Taiwan, 116
        • Taipei Municipal Wanfang Hospital Managed by Taipei Medical University
      • Taipei City, Taiwan, 110
        • Taipei Medical University Hospital
  • United Kingdom
      • London, United Kingdom, E1 1FR
        • Royal London Hospital
  • United States
    • California
      • Glendora, California, United States, 91741
        • Paradise Clinical Research Group LLC
      • Huntington Park, California, United States, 90255
        • IMD Clinical Trials
      • Lakewood, California, United States, 90712
        • Advanced Medical Research, LLC
      • Los Alamitos, California, United States, 90720
        • Medicine and Nephrology Associates
      • Los Angeles, California, United States, 90022
        • Academic Medical Research Institute
      • Mission Viejo, California, United States, 92691
        • Allameh Medical Corporation
      • Northridge, California, United States, 91325
        • Valley Clinical Trials
      • Pico Rivera, California, United States, 90660
        • Integrity Medical Discovery
      • Sacramento, California, United States, 95817
        • UC Davis Medical Group GI Unit
      • San Dimas, California, United States, 91773
        • North America Research Institute
    • Florida
      • Coral Springs, Florida, United States, 33313
        • West Broward Research Institute
      • Fort Lauderdale, Florida, United States, 33316
        • Florida Kidney Physicians
      • Gainesville, Florida, United States, 32608
        • University of Florida
      • Miami Beach, Florida, United States, 33140
        • New Phase Clinical Trials
      • Tampa, Florida, United States, 33603
        • Genesis Clinical Research
    • Georgia
      • Acworth, Georgia, United States, 30101
        • American Clinical Trials
    • Idaho
      • Boise, Idaho, United States, 836432
        • Boise Kidney and Hypertension Institute
      • Chubbuck, Idaho, United States, 83202
        • Care Institute
    • Illinois
      • Chicago, Illinois, United States, 60637
        • The University of Chicago Medical Center
      • Chicago, Illinois, United States, 60616
        • Insight Hospital & Medical Center Chicago
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa
    • Maryland
      • Takoma Park, Maryland, United States, 20854
        • Washington Nephrology Associates
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
      • Roseville, Michigan, United States, 48066
        • St. Clair Nephrology Research
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Saint Louis University
    • Nevada
      • Las Vegas, Nevada, United States, 89052
        • Nevada Kidney Disease & Hypertension Center
    • New Hampshire
      • Portsmouth, New Hampshire, United States, 03801
        • Seacoast Kidney & Hypertension Specialists
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • UNC Chapel Hill
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hospital
    • South Dakota
      • Dakota Dunes, South Dakota, United States, 57049
        • Dunes Clinical Research
    • Tennessee
      • Knoxville, Tennessee, United States, 37923
        • Knoxville Kidney Center
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center
    • Texas
      • El Paso, Texas, United States, 79905
        • Texas Tech Health Sciences
      • Houston, Texas, United States, 77091
        • United Memorial Medical Center
      • Houston, Texas, United States, 77004
        • Plaza Nephrology
      • Houston, Texas, United States, 77090
        • Clinical Research Strategies, Inc
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • 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:

  1. The participant is male or female, 30 to 80 years of age on the date of informed consent.
  2. The participant has a clinical diagnosis of T2DM in their health record.
  3. The participant has a clinical diagnosis of diabetic nephropathy as the underlying cause of renal disease (diagnosis does not have to be confirmed via renal biopsy) in their health record.
  4. The participant has a serum glycosylated hemoglobin (HbA1c) less than 10% at the Screening Visit.
  5. The participant has a documented clinical diagnosis of an eGFR greater than or equal to 20 and less than or equal to 50 mL/min/1.73m², not requiring renal dialysis.
  6. The participant has a urinary albumin-to-creatinine ratio (UACR) of greater than or equal to 300 and less than or equal to 5,000 mg/g.

Exclusion Criteria:

  1. The participant has a history of type 1 diabetes mellitus.
  2. The participant has a history of renal transplantation.
  3. The participant 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, across 3 measurements while seated.
  4. The participant 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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Cohort 1
Participants randomized to Cohort 1 will receive 2 sham injections of REACT. Second injection to occur 3 months (+30 days) after the first REACT injection. Sham procedures simulate real procedure. No tissue is taken during biopsy and nothing is injected into kidney for injection.
Biological: Renal Autologous Cell Therapy (REACT)
Participants will receive either 2 REACT injections or 2 Sham REACT injections into biopsied and non-biopsied contralateral kidneys 3 months apart.
Experimental: Cohort 2
Participants randomized to Cohort 2 will receive 2 injections of REACT. The second injection to occur 3 months (+30 days) after the first REACT injection.
Biological: Renal Autologous Cell Therapy (REACT)
Participants will receive either 2 REACT injections or 2 Sham REACT injections into biopsied and non-biopsied contralateral kidneys 3 months apart.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Composite Endpoint
Time Frame: up to 60 Months

The time from first injection to the earliest of:

  • At least 40% reduction in eGFR, using the 2009 CKD-EPI serum creatinine equation, sustained for 30 days or
  • eGFR <15 mL/min/1.73m² using the 2009 CKD-EPI serum creatinine equation, sustained for 30 days and/or chronic dialysis, and/or renal transplant or
  • Renal or cardiovascular death
up to 60 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary Composite Endpoint
Time Frame: up to 60 Months

The time from first injection to the earliest of:

  • At least 40% reduction in eGFR, using the 2009 CKD-EPI serum creatinine equation, sustained for 30 days or
  • eGFR <15 mL/min/1.73m² using the 2009 CKD-EPI serum creatinine equation, sustained for 30 days and/or chronic dialysis, and/or renal transplant
  • Increase of UACR of at least 30% and of at least 30mg/g, using the random urine microalbumin/urine creatinine ratio sustained for 90 days or
  • Renal or Cardiovascular death
up to 60 Months

Collaborators and Investigators

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

Sponsor

Prokidney

Collaborators

PPD
Iqvia Pty Ltd

Investigators

  • Study Director: Study Director, 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)

January 5, 2022

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

October 18, 2021

First Submitted That Met QC Criteria

October 18, 2021

First Posted (Actual)

October 29, 2021

Study Record Updates

Last Update Posted (Actual)

March 13, 2024

Last Update Submitted That Met QC Criteria

March 12, 2024

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REGEN-006

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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