- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02836574
A Study of Renal Autologous Cell Therapy (REACT) in Type 2 Diabetics With Chronic Kidney Disease
A Phase 2 Prospective, Randomized, Double-Arm, Deferred Treatment, Open Label, Repeat Dose, Safety and Efficacy Study of Renal Autologous Cell Therapy (REACT) in Subjects With Type 2 Diabetes and Chronic Kidney Disease
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Part 1: Multi-center, prospective, open-label, randomized, double-arm, deferred treatment study whereby eligible subjects will be randomized 1:1 after kidney biopsy to receive up to 2 injections of REACT (made from expanded autologous selected renal cells) into the biopsied kidney beginning as soon as REACT can be prepared, or the same series of up to 2 injections given 6 months (+4 weeks) apart beginning 12 months after renal biopsy. Subjects will be followed through 23 months after the last injection.
Study Part 2: An open-label extension study in which eligible subjects will be followed for an additional 36 months of long-term follow-up. Subjects will be able to roll from Study Part 2 into a Long Term Follow-Up Master protocol for up to 5 years
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Arizona
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Tucson, Arizona, United States, 85724
- University of Arizona
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Colorado
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Denver, Colorado, United States, 80210
- Kidney Associates of Colorado
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Connecticut
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New Haven, Connecticut, United States, 06520
- Yale Univeristy
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Florida
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Gainesville, Florida, United States, 32610
- University of Florida
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Idaho
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Meridian, Idaho, United States, 83642
- Boise Kidney and Hypertension Institute
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Illinois
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Chicago, Illinois, United States, 60637
- University of Chicago Medical Center
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Kentucky
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Louisville, Kentucky, United States, 40202
- University of Louisville
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Louisiana
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Baton Rouge, Louisiana, United States, 70808
- Renal Associates of Baton Rouge
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Michigan
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Ann Arbor, Michigan, United States, 48109
- University of Michigan
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Kalamazoo, Michigan, United States, 49007
- Paragon Health
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Mississippi
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Tupelo, Mississippi, United States, 38801
- Nephrology & Hypertension Associates
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New York
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New York, New York, United States, 45246
- Mt. Sinai Hospital
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- University of North Carolina- Chapel Hill
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Pennsylvania
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Allentown, Pennsylvania, United States, 18103
- Lehigh Valley Health Network
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Tennessee
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Nashville, Tennessee, United States, 37212
- Vanderbilt University
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Wisconsin
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Madison, Wisconsin, United States, 53705
- University of Wisconsin-Madison
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria for Study Part 1:
- The subject is male or female, 30 to 80 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 20 and 50 mL/min/1.73m².
- The subject has blood pressure less than 150/90 at the Screening Visit.
- The subject has stable blood pressure and is maintained on a stable anti-hypertensive medication regimen.
- A minimum of 2 measurements of eGFR or sCr should be obtained at least 3 months apart prior to the Screening Visit or within the previous 18 months to define the rate of progression of CKD.
Exclusion Criteria for Study Part 1:
- 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.
Inclusion Criteria for Study Part 2:
- The subject is willing and able to provide signed informed consent.
- The subject was enrolled into Part 1 of the study and received at least one REACT injection.
Exclusion Criteria for Study Part 2:
1. The subject is currently receiving renal dialysis.
Study Plan
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: Immediate Treatment
Renal Autologous Cell Therapy (REACT) immediate treatment - Patients who are randomized to receive their first treatment of 2 injections of REACT as soon as REACT product is made available.
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Autologous selected renal cells (SRC).
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Active Comparator: Delayed Treatment
Renal Autologous Cell Therapy (REACT) delayed treatment - Patients who are randomized to receive standard of care treatment for the first 12 months after REACT product is made available before receiving 2 injections of REACT.
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Autologous selected renal cells (SRC).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Renal Function
Time Frame: Through 24 months following last REACT injection for active arm and at least 12 months following last REACT injection for the deferred arm
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Serial measurements of estimated glomerular filtration rate (eGFR) obtained pre-randomization and at three-month intervals through 24 months after the last REACT injection in the active treatment group and at least 12 months post last REACT injection in the deferred treatment group.
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Through 24 months following last REACT injection for active arm and at least 12 months following last REACT injection for the deferred arm
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Treatment emergent adverse events
Time Frame: Through 24 months following last REACT injection for the active arm and at least 12 months following the last REACT injection for the deferred arm
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Treatment emergent adverse events, serial safety laboratory results
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Through 24 months following last REACT injection for the active arm and at least 12 months following the last REACT injection for the deferred arm
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Brian Johnston, CTI
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Glucose Metabolism Disorders
- Metabolic Diseases
- Urologic Diseases
- Endocrine System Diseases
- Disease Attributes
- Diabetes Mellitus
- Renal Insufficiency
- Chronic Disease
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Diabetes Mellitus, Type 2
- Kidney Diseases
- Renal Insufficiency, Chronic
Other Study ID Numbers
- RMCL-002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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