Status:
WITHDRAWN
A Study of Renal Autologous Cell Therapy (REACT) in Participants With Type 2 Diabetes and Chronic Kidney Disease
Lead Sponsor:
Prokidney
Conditions:
Type 2 Diabetes Mellitus
Chronic Kidney Diseases
Eligibility:
All Genders
30-80 years
Phase:
PHASE3
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-bio...
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 sh...
Eligibility Criteria
Inclusion
- The participant is male or female, 30 to 80 years of age on the date of informed consent.
- The participant has a clinical diagnosis of T2DM in their health record.
- 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.
- The participant has a serum glycosylated hemoglobin (HbA1c) less than 10% at the Screening Visit.
- The participant has a documented clinical diagnosis of an eGFR greater than or equal to 20 and less than or equal to 44 mL/min/1.73m², not requiring renal dialysis.
- The participant has an urinary albumin-to-creatinine ratio (UACR) of greater than or equal to 300 and less than or equal to 5,000 mg/g.
Exclusion
- The participant has a history of type 1 diabetes mellitus.
- The participant has a history of renal transplantation.
- 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.
- 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.
Key Trial Info
Start Date :
July 17 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 3 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05286853
Start Date
July 17 2024
End Date
September 3 2024
Last Update
September 25 2024
Active Locations (3)
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1
IMIM Hospital del Mar Medical Research Institute
Barcelona, Spain, 08003
2
Hospital Universitario Vall D'Hebron
Barcelona, Spain, 08035
3
Hospital Universitario 12 de Octubre
Madrid, Spain, 28026