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A Study of REACT® in Subjects With Type 2 Diabetes Mellitus and 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05099770
Recruitment Status : Recruiting
First Posted : October 29, 2021
Last Update Posted : June 24, 2022
Sponsor:
Collaborators:
Iqvia Pty Ltd
PPD
Information provided by (Responsible Party):
Prokidney

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Chronic Kidney Diseases Biological: Renal Autologous Cell Therapy (REACT®) Phase 3

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 24 months post-last sham REACT® injection. Cohort 2 participants will receive 2 REACT® injections 3 months apart (+30 days) and be followed for 24 months post-last REACT® injection.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3 Randomized Controlled Study of Renal Autologous Cell Therapy (REACT®) in Subjects With Type 2 Diabetes and Chronic Kidney Disease (REGEN-006)
Actual Study Start Date : January 5, 2022
Estimated Primary Completion Date : February 2026
Estimated Study Completion Date : February 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Primary Composite Endpoint [ Time Frame: 24+ months ]

    The time from randomization 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 and/or chronic dialysis, and/or renal transplant using the 2009 CKD-EPI serum creatinine equation, sustained for 30 days or
    • Increase of UACR of at least 30% and of at least 30 mg/g, using the random urine microalbumin/urine creatinine ratio sustained for 30 days or
    • Renal or cardiovascular death


Secondary Outcome Measures :
  1. Secondary Composite Endpoint [ Time Frame: 24+ months ]

    The time from randomization 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 and/or chronic dialysis, and/or renal transplant using the 2009 CKD-EPI serum creatinine equation, sustained for 30 days or
    • Renal or cardiovascular death


Eligibility Criteria
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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 30 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. Participants with blood pressure outside of this range prior to biopsy and injection, may continue if approved by the Medical Monitor.
  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.
Contacts and Locations
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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): NCT05099770


Contacts
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Contact: Lisa Durette 1-802-310-9479 lisa.durette@IQVIA.com

Locations
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United States, California
IMD Clinical Trials Recruiting
Huntington Park, California, United States, 90255
Contact: Victor Carabello, MD    323-868-4400    victor@imdclinicaltrials.com   
Advanced Medical Research, LLC Recruiting
La Palma, California, United States, 90712
Contact: Adarsh Daswani, MD    562-867-8195      
Advanced Medical Research, LLC Recruiting
Lakewood, California, United States, 90712
Contact: Adarsh Daswani, MD    562-867-8195    amr@advmedresearch.com   
Allameh Medical Corporation Recruiting
Mission Viejo, California, United States, 92691
Contact: Reza Allamehzadeh, MD    949-581-2002      
Valley Clinical Trials Recruiting
Northridge, California, United States, 91325
Contact: Moufid Nemeh, MD    818-885-0063      
United States, Florida
West Broward Research Institute Recruiting
Coral Springs, Florida, United States, 33313
Contact: Paramjit Kalirao, MD    954-739-2221      
Genesis Clinical Research Recruiting
Tampa, Florida, United States, 33603
Contact: Jesus Navarro, MD    813-873-1016      
United States, Georgia
American Clinical Trials Terminated
Acworth, Georgia, United States, 30101
United States, Idaho
Boise Kidney and Hypertension Institute Recruiting
Boise, Idaho, United States, 836432
Contact: Amy Henderson    208-472-0518    amy.henderson@frenovarenalresearch.com   
Contact: LuAnn Schneider    208-472-0518    LuAnn.Schneider@frenovarenalresearch.com   
United States, Michigan
St. Clair Nephrology Research Recruiting
Roseville, Michigan, United States, 48066
Contact: Keith Bellovich, DO    586-218-5800      
United States, New Hampshire
Seacoast Kidney & Hypertension Specialists Recruiting
Portsmouth, New Hampshire, United States, 03801
Contact: Sucharit Joshi, MD    603-436-3433    sucharit.joshi@gmail.com   
United States, Texas
Texas Tech Health Sciences Recruiting
El Paso, Texas, United States, 79905
Contact: Adeel Ahmed, MD    915-215-8000      
Clinical Research Strategies, Inc Recruiting
Houston, Texas, United States, 77090
Contact: Christopher Kwoh, MD         
Sponsors and Collaborators
Prokidney
Iqvia Pty Ltd
PPD
Investigators
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Study Director: Ashley Johns SVP Clinical Operations, ProKidney
More Information
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Responsible Party: Prokidney
ClinicalTrials.gov Identifier: NCT05099770    
Other Study ID Numbers: REGEN-006
First Posted: October 29, 2021    Key Record Dates
Last Update Posted: June 24, 2022
Last Verified: June 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
Keywords provided by Prokidney:
REACT
Type 2 Diabetes Mellitus
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Renal Insufficiency