Evaluate Efficacy Study of Combination Therapy of Everolimus and Low Dose Tacrolimus in Renal All… (NCT02036554) | Clinical Trial Compass
UnknownPhase 4
Evaluate Efficacy Study of Combination Therapy of Everolimus and Low Dose Tacrolimus in Renal Allograft Recipients
South Korea234 participantsStarted 2013-03
Plain-language summary
To evaluate prevention effect of combination therapy of Everolimus and low-dose Tacrolimus in comparison with standard-dose Tacrolimus therapy with Mycophenolic acid on the New Onset Diabetes Mellitus after transplantation in the renal allograft recipients
Who can participate
Age range20 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age ≥ 20 year old
✓. At least 3 months after kidney transplantation
✓. Subject who is using Tacrolimus ± purine synthesis inhibitor + steroid without change within the past 3 months (except the dosage)
✓. MDRD eGFR ≥ 50 mL/min or serum creatinine \< 2.0mg/dL within the past 3 months in the 6months after kidney transplantation
✓. Rate of change of serum creatinine \< +30% within the past 3 months in the 6months after kidney transplantation (if serum creatinine decreased, without rate of change is inclusion possible. if serum creatinine result was normal,regardless of the rate of change is able to register.)
✓. Urine protein/creatinine ratio \< 1g/g Cr (spot urine) Subject who is not applicable to the diagnostic criteria NODAT on
✓. the baseline in the 6months after kidney transplantation
✓. Subjects who agree with written informed consent
Exclusion criteria
✕. Subjects who received combined non-renal transplantation
✕. Subject who received re-transplantation
✕. ABO blood group incompatible(when anti-ABO Antibody titer \<1:128 is inclusion possible.)
✕. Sensitized patients before transplantation
What they're measuring
1
Change from Baseline in Development of NODAT (Fasting glucose ≥ 126 mg/dL, Random glucose ≥ 200 mg/dL) at 12 months