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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05099770
Registration number
NCT05099770
Ethics application status
Date submitted
18/10/2021
Date registered
29/10/2021
Date last updated
13/03/2024
Titles & IDs
Public title
A Study of REACT in Subjects With Type 2 Diabetes Mellitus and Chronic Kidney Disease
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Scientific 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)
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Secondary ID [1]
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REGEN-006
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes Mellitus
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Chronic Kidney Diseases
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Condition category
Condition code
Renal and Urogenital
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Kidney disease
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Renal and Urogenital
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Other renal and urogenital disorders
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Metabolic and Endocrine
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Diabetes
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Renal Autologous Cell Therapy (REACT)
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.
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.
Other interventions: 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.
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Primary Composite Endpoint
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Assessment method [1]
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The time from first injection 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 CKD-EPI serum creatinine equation, sustained for 30 days and/or chronic dialysis, and/or renal transplant or
Renal or cardiovascular death
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Timepoint [1]
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up to 60 Months
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Secondary outcome [1]
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Secondary Composite Endpoint
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Assessment method [1]
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The time from first injection 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 CKD-EPI serum creatinine equation, sustained for 30 days and/or chronic dialysis, and/or renal transplant
Increase of UACR of at least 30% and of at least 30mg/g, using the random urine microalbumin/urine creatinine ratio sustained for 90 days or
Renal or Cardiovascular death
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Timepoint [1]
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up to 60 Months
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Eligibility
Key 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 300 and less than or equal to 5,000 mg/g.
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Minimum age
30
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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,
across 3 measurements while seated.
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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
5/01/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/02/2027
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Actual
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Sample size
Target
600
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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St. George Hospital - Kogarah
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Recruitment postcode(s) [1]
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2217 - Kogarah
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Recruitment outside Australia
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United States of America
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California
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United States of America
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Florida
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United States of America
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Georgia
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Idaho
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Illinois
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Iowa
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Missouri
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Rhode Island
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South Dakota
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Tennessee
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Texas
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Canada
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Ontario
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Taiwan
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New Taipei City
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Taiwan
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Taichung
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Taiwan
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Taipei City
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Taiwan
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Taipei
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United Kingdom
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Prokidney
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Address
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Iqvia Pty Ltd
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Commercial sector/Industry
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PPD
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05099770
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Public notes
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Contacts
Principal investigator
Name
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Study Director
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Address
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Prokidney
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05099770
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