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Study of Renal Autologous Cell Therapy (REACT®) in Subjects With Type 1 or 2 Diabetes and Chronic Kidney Disease (REGEN-007)

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: NCT05018416
Recruitment Status : Recruiting
First Posted : August 24, 2021
Last Update Posted : April 22, 2022
Sponsor:
Information provided by (Responsible Party):
Prokidney

Study Description
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Brief Summary:
The purpose of this study is to assess the safety, efficacy, and durability of up to two REACT® injections delivered percutaneously into biopsied and non-biopsied contralateral kidneys on renal function progression in two different cohorts of subjects with T1DM or T2DM and CKD.

Condition or disease Intervention/treatment Phase
Chronic Kidney Diseases Type 1 Diabetes Mellitus Type 2 Diabetes Mellitus Biological: Renal Autologous Cell Therapy (REACT®) Phase 2

Detailed Description:

The objective of this study is to assess the safety, efficacy, and durability of up to two REACT® injections delivered percutaneously into biopsied and non-biopsied contralateral kidneys on renal function progression in two different cohorts of subjects with T1DM or T2DM and CKD:

  • Cohort 1: Two scheduled REACT® injections given 3 months (+60 days) within 24-month follow-up
  • Cohort 2: One scheduled REACT® injection with a possible second REACT® injection, no less than 3 months after the first one, within 30 days (+30 days) of meeting a renal function redose trigger (triggered up to 18 months following the first REACT® injection) within 24-month follow-up.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Open-Labeled, Repeat Dose, Safety and Efficacy Study of Renal Autologous Cell Therapy (REACT®) in Subjects With Type 1 or 2 Diabetes and Chronic Kidney Disease (REGEN-007)
Actual Study Start Date : July 27, 2021
Estimated Primary Completion Date : May 20, 2025
Estimated Study Completion Date : May 20, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arms and Interventions
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Arm Intervention/treatment
Experimental: 2 REACT® injections
Cohort 1 subjects will receive 2 REACT® injections in the biopsied and non-biopsied contralateral kidneys 3 months apart (+60 days).
 Biological: Renal Autologous Cell Therapy (REACT®)
Autologous selected renal cells (SRC)
Experimental: 1 REACT® Injection
Cohort 2 subjects will receive 1 REACT® injection into the biopsied kidney and if a pre-defined trigger is met, will undergo a second REACT® injection into the contralateral kidney.
 Biological: Renal Autologous Cell Therapy (REACT®)
Autologous selected renal cells (SRC)


Outcome Measures
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Primary Outcome Measures :
  1. Improvement in renal function progression rate as indicated by the change from pre-injection baseline value in total (acute + chronic) slope of estimated glomerular filtration rate (eGFR) over 24 months [ Time Frame: Screening thru month 34 ]
  2. Procedural and investigational product-related treatment-emergent adverse events (TEAEs) obtained through 24 months after the last REACT injection. [ Time Frame: Screening thru 24 months after the last injection of study drug ]

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. Male or female aged 30 to 80 years, inclusive, on the date informed consent is signed.
  2. Clinical diagnosis of T1DM or T2DM, controlled per institutional standard of care.
  3. The subject has a clinical diagnosis of diabetic nephropathy as the underlying cause of renal disease (diagnosis does not have to be confirmed via renal biopsy).
  4. The subject has a serum glycosylated hemoglobin (HbA1c) level less than 10% at the Screening Visit.
  5. The subject has a documented clinical diagnosis of an eGFR between 20 and 50 mL/min/1.73m² inclusive not requiring renal dialysis.

Exclusion Criteria:

  1. The subject has a history of renal transplantation.

  2. The subject 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.

    Subjects with blood pressure outside of this range prior to biopsy/injection may continue if approved by the Medical Monitor.

  3. The subject 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): NCT05018416


Contacts
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Contact: Nikola Mirkovic 201-575-0950 nikola.mirkovic@prokidney.com
Contact: Britt Oraskovich 910-558-2054 britt.oraskovich@ppd.com

Locations
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United States, Colorado
Kidney Associates of Colorado, P.C. - Frenova Recruiting
Denver, Colorado, United States, 80210-5073
Contact: Rachita Prakash, MD    225-757-7118      
United States, Idaho
Boise Kidney and Hypertension Institute - Frenova Recruiting
Nampa, Idaho, United States, 83687
Contact: Arnold Silva, MD    208-472-0525      
United States, Michigan
Paragon Health, PC d/b/a Nephrology Center, PC - Frenova Recruiting
Kalamazoo, Michigan, United States, 49007-3889
Contact: Ahmed Aqeel, MD    269-365-7523      
United States, Mississippi
Nephrology and Hypertension Associates Ltd - Frenova Recruiting
Tupelo, Mississippi, United States, 38801-6560
Contact: Thomas Wooldridge, MD    662-255-0926      
Sponsors and Collaborators
Prokidney
Investigators
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Study Director: Ashley Johns Prokidney
More Information
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Responsible Party: Prokidney
ClinicalTrials.gov Identifier: NCT05018416    
Other Study ID Numbers: REGEN-007
First Posted: August 24, 2021    Key Record Dates
Last Update Posted: April 22, 2022
Last Verified: April 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:
Kidney Biopsy
REACT
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Autoimmune Diseases
Immune System Diseases
Renal Insufficiency