Knoxville Kidney Center | Knoxville, TN
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About
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.
Full 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 to the global trial end date. Cohort 2 participants will receive 2 REACT injections 3 months apart (+30 days) and be followed to the global trial end date. This event driven study is estimated to have a total maximum duration of 5 years.
Enrollment
Sex
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Volunteers
Inclusion criteria
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 9.5% at the Screening Visit.
The participant has a documented clinical diagnosis of either:
eGFR greater than or equal to 20 and less than 30 mL/min/1.73m², not requiring renal dialysis. UACR level cannot exceed 5000 mg/g (565 mg/mmol) OR: eGFR of 30 to less than or equal to 35 mL/min/1.73m² AND UACR of 300 to less than or equal to 5000mg/g (33.9 mg/mmol to less than or equal to 565 mg/mmol).
Systolic blood pressure of ≤ 140 mm Hg and diastolic blood pressure of ≤ 90 mm Hg at Screening (based on the average of 3 measurements obtained while seated) and maintained during the screening period until randomization.
On a clinically relevant and stable dose of an angiotensin converting-enzyme inhibitor (ACEI) OR an angiotensin receptor blocker (ARB), unless not tolerated or contraindicated.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
685 participants in 2 patient groups
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Central trial contact
Elizabeth Lotz; Catherine Taylor
Data sourced from clinicaltrials.gov
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