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

September 23, 2024 updated by: Prokidney

A Phase 3 Randomized Controlled Study of REACT in Participants With Type 2 Diabetes and Chronic Kidney Disease (REGEN-016)

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

Withdrawn

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 for 5 years post last simulated injection.. Cohort 2 participants will receive 2 REACT injections 3 months apart (+30 days) and be followed for 5 years post last injection of the investigational product.

Study Type

Interventional

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 Locations

  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitario Vall d'Hebron
      • Barcelona, Spain, 08003
        • IMIM Hospital del Mar Medical Research Institute
      • Madrid, Spain, 28026
        • Hospital Universitario 12 de Octubre

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 44 mL/min/1.73m², not requiring renal dialysis.
  6. The participant has an 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 level 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
Experimental: Experimental (REACT injections)
Participants randomized to the experimental arm will receive 2 injections of REACT.
Biological: Renal Autologous Cell Therapy (REACT)
Participants receiving institutional standard of care will have a kidney biopsy followed by 2 REACT injections into biopsied and non-biopsied contralateral kidneys 3 months (+30 days) apart and will be followed for 5 years (60 months) since last REACT injection.
Sham Comparator: Sham Procedure
Participants randomized to the Sham Comparator arm will have 2 sham procedures
Procedure: Sham Comparator
Participants receiving institutional standard of care will have 2 sham procedures that simulate real biopsy and injection procedure. No tissue is taken during biopsy and nothing is injected into kidney. The second sham procedure will occur 3 months (+30 days) after the first sham procedure. Participants will be followed for 5 years (60 months) since last sham REACT injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Composite Endpoint
Time Frame: up to 60 Months post last injection of the investigational product or the last simulated injection.

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 serum creatinine equation, sustained for 30 days and/or chronic dialysis , and/or renal transplant or
  • Renal or cardiovascular death
up to 60 Months post last injection of the investigational product or the last simulated injection.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
First Secondary Endpoint: Time to progression of Chronic Kidney Disease
Time Frame: up to 60 Months post last injection of the investigational product or the last simulated injection

Time to progression of Chronic Kidney Disease

  • At least 40% reduction in eGFR, using the 2009 CKD-EPI serum creatinine equation, sustained for 30 days or
  • eGFR <15mL/min/1.73m² using the 2009 CKD-EPI serum creatinine equation, sustained for 30 days and/or chronic dialysis, and/or renal transplant or or
  • Renal death
up to 60 Months post last injection of the investigational product or the last simulated injection
Second Secondary Endpoint: Time to End Stage Renal Disease
Time Frame: up to 60 Months post last injection of the investigational product or the last simulated injection

Time to End Stage Renal Disease

  • 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 death.
up to 60 Months post last injection of the investigational product or the last simulated injection

Collaborators and Investigators

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

Sponsor

Prokidney

Collaborators

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)

July 17, 2024

Primary Completion (Actual)

September 3, 2024

Study Completion (Actual)

September 3, 2024

Study Registration Dates

First Submitted

February 24, 2022

First Submitted That Met QC Criteria

March 9, 2022

First Posted (Actual)

March 18, 2022

Study Record Updates

Last Update Posted (Actual)

September 25, 2024

Last Update Submitted That Met QC Criteria

September 23, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REGEN-016

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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