- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03270956
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
Status
Completed
Conditions
Intervention / Treatment
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- University of Arizona [WITHDRAWN]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- Vanderbilt University [WITHDRAWN]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:
- The subject is male or female, 30 to 65 years of age on the date of informed consent.
- The subject has an established diagnosis of T2DM.
- The subject has an established diagnosis of diabetic nephropathy as the underlying cause of renal disease.
- 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.
- 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.
- 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:
- The subject has a history of type 1 diabetes mellitus.
- The subject has a history of renal transplantation.
- The subject has a serum HbA1c level greater than 10% at the Screening Visit.
- The subject has uncontrolled diabetes (defined as metabolically unstable by the Investigator).
- 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
Collaborators
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- REGEN-003
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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