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A Study of Renal Autologous Cell Therapy (REACT®) in Participants With Type 2 Diabetes 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: NCT05286853
Recruitment Status : Not yet recruiting
First Posted : March 18, 2022
Last Update Posted : March 31, 2022
Sponsor:
Collaborator:
Iqvia Pty Ltd
Information provided by (Responsible Party):
Prokidney

Brief Summary:
The objective of this study is to access the efficacy, safety and durability of up to 2 REACT® injections given 3 months apart and delivered percutaneously into biopsied and non-biopsied contralateral kidneys on renal functions in participants with type 2 diabetes mellitus (T2DM) and chronic kidney disease (CKD).

Condition or disease Intervention/treatment Phase
T2DM (Type 2 Diabetes Mellitus) CKD (Chronic Kidney Disease) Biological: Renal Autologous Cell Therapy (REACT®) Phase 3

Detailed Description:
Randomized multi-center, open-label, 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 institutional standard of care and be followed for 32 months post randomization. Cohort 2 participants will receive 2 REACT® injections into biopsied and non-biopsied contralateral kidneys 3 months apart (+30 days) and be followed for 28 months post-first REACT® injection. Total study duration for all participants is 34 months including screening period.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3 Randomized Controlled Study of REACT® in Participants With Type 2 Diabetes and Chronic Kidney Disease (REGEN-016)
Estimated Study Start Date : October 2022
Estimated Primary Completion Date : March 2027
Estimated Study Completion Date : March 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
No Intervention: Cohort 1: Standard of Care Arm
Participants randomized to Cohort 1 will undergo institutional Standard of Care and will not be receiving REACT® . Participants will be followed 32 months at the same time intervals as Cohort 2.
Experimental: Cohort 2: 2 REACT® Injections
Participants randomized to Cohort 2 will receive 2 REACT® injections into biopsied and non-biopsied contralateral kidneys 3 months apart (+30 days).
Biological: Renal Autologous Cell Therapy (REACT®)
Participants will receive 2 REACT® injections into biopsied and non-biopsied contralateral kidneys 3 months apart.




Primary Outcome Measures :
  1. Primary Efficacy Endpoint [ Time Frame: Baseline through Month 34 ]

    The time from baseline 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 using the 2009 serum creatinine equation, sustained for 30 days and/or chronic dialysis , and/or renal transplant 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 90 days or
    • Renal or cardiovascular death


Secondary Outcome Measures :
  1. Secondary Efficacy Endpoint [ Time Frame: Baseline through Month 34 ]

    The time from baseline to the earliest of:

    • At least 40% reduction in eGFR, using the 2009 CKD-EPI serum creatinine equation, sustained for 30 days or
    • eGFR <15mL/min/1.73m² using the 2009 CKD-EPI serum creatinine equation, sustained for 30 days and/or chronic dialysis, and/or renal transplant or
    • Renal or cardiovascular death



Information from the National Library of Medicine

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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 an 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 level less than 10 g/dL and is not responsive to the standard medical intervention for CKD-related anemia prior to randomization.

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): NCT05286853


Contacts
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Contact: Lisa Durette 1-802-310-9473 lisa.durette@IQVIA.com

Sponsors and Collaborators
Prokidney
Iqvia Pty Ltd
Investigators
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Study Director: Ashley Johns SVP Clinical Operations, ProKidney
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Responsible Party: Prokidney
ClinicalTrials.gov Identifier: NCT05286853    
Other Study ID Numbers: REGEN-016
First Posted: March 18, 2022    Key Record Dates
Last Update Posted: March 31, 2022
Last Verified: March 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