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A Study of Autologous Renal Autologous Cell Therapy (REACT®) in Patients With Diabetic Chronic Kidney Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03270956
Recruitment Status : Active, not recruiting
First Posted : September 1, 2017
Last Update Posted : February 15, 2022
Sponsor:
Collaborator:
CTI Clinical Trial and Consulting Services
Information provided by (Responsible Party):
Prokidney

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Chronic Kidney Disease Biological: Renal Autologous Cell Therapy (REACT®) Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: Open label
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : April 25, 2018
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

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.
Biological: Renal Autologous Cell Therapy (REACT®)
Autologous selected renal cells (SRC)




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The subject is male or female, 30 to 65 years of age on the date of informed consent.
  2. The subject has an established diagnosis of T2DM.
  3. The subject has an established diagnosis of diabetic nephropathy as the underlying cause of renal disease.
  4. 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.
  5. 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.
  6. 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:

  1. The subject has a history of type 1 diabetes mellitus.
  2. The subject has a history of renal transplantation.
  3. The subject has a serum HbA1c level greater than 10% at the Screening Visit.
  4. The subject has uncontrolled diabetes (defined as metabolically unstable by the Investigator).
  5. The subject has hemoglobin levels less than 9 g/dL prior to each REACT injection.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03270956


Locations
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United States, Arizona
University of Arizona [WITHDRAWN]
Tucson, Arizona, United States, 85724
United States, Idaho
Boise Kidney & Hypertension Institute
Boise, Idaho, United States, 83642
United States, North Carolina
University of North Carolina- Chapel Hill
Chapel Hill, North Carolina, United States, 27599
United States, Tennessee
Vanderbilt University [WITHDRAWN]
Nashville, Tennessee, United States, 37212
Sponsors and Collaborators
Prokidney
CTI Clinical Trial and Consulting Services
Investigators
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Study Director: Ashley Johns Prokidney
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Responsible Party: Prokidney
ClinicalTrials.gov Identifier: NCT03270956    
Other Study ID Numbers: REGEN-003
First Posted: September 1, 2017    Key Record Dates
Last Update Posted: February 15, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Renal Insufficiency