A Study of Renal Autologous Cell Therapy (REACT) in Type 2 Diabetics With Chronic Kidney Disease (NCT02836574) | Clinical Trial Compass
CompletedPhase 2
A Study of Renal Autologous Cell Therapy (REACT) in Type 2 Diabetics With Chronic Kidney Disease
United States83 participantsStarted 2016-09
Plain-language summary
To assess the safety and efficacy of up to two REACT injections given 6 months (+4 weeks) apart and delivered into the biopsied kidney using a percutaneous approach in participants with Type 2 Diabetes Mellitus (T2DM) and Chronic Kidney Disease (CKD).
Who can participate
Age range30 Years – 80 Years
SexALL
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Inclusion criteria
✓. The subject is male or female, 30 to 80 years of age on the date of informed consent.
✓. The subject has an established diagnosis of Type 2 Diabetes Mellitus.
✓. The subject has an established diagnosis of diabetic nephropathy as the underlying cause of renal disease.
✓. The subject has an established diagnosis of Chronic Kidney Disease not requiring renal dialysis, defined as having an Estimated Glomerular Filtration Rate (eGFR) between 20 and 50 mL/min/1.73m².
✓. The subject has blood pressure less than 150/90 at the Screening Visit.
✓. The subject has stable blood pressure and is maintained on a stable anti-hypertensive medication regimen.
✓. A minimum of 2 measurements of Estimated Glomerular Filtration Rate (eGFR) or serum creatine ratio (sCr) should be obtained at least 3 months apart prior to the Screening Visit or within the previous 18 months to define the rate of progression of Chronic Kidney Disease (CKD).
Exclusion criteria
✕. The subject has a history of type 1 diabetes mellitus.
✕. The subject has a history of renal transplantation.
✕. The subject has a serum Hemoglobin A1c (HbA1c) level greater than 10% at the Screening Visit.
✕. The subject has uncontrolled diabetes (defined as metabolically unstable by the Investigator).
What they're measuring
1
Change in Renal Function
Timeframe: Through 24 months following last REACT injection for active arm and at least 12 months following last REACT injection for the deferred arm