Disorder Related to Renal Transplantation Clinical Trial
Official title:
Comparative Clinical Study of Reduced Dose of Tacrolimus and Standard Dose of Mycophenolate Mofetil vs. Conventional Dose of Tacrolimus and Reduced Dose of Mycophenolate Mofetil in De Novo Renal Transplant Recipients
A prospective, multicenter, open-label, randomized and parallel-group clinical trial was conducted at four transplant centers in Korea. This clinical study was designed to compare the efficacy and tolerability of reduced-dose tacrolimus with standard-dose mycophenolate mofetil (MMF) versus standard-dose tacrolimus with reduced-dose MMF.
A prospective, multicenter, open-label, randomized and parallel-group clinical trial was
conducted at four transplant centers in Korea. The total sample size was 108 and eligible
patients were randomly assigned in a 1:1 ratio to either study or control group. For six
months study period, graft function, the incidence of efficacy failure and adverse events
were compared.
The total sample size was 108 and eligible patients were randomly assigned in a 1:1 ratio to
either study or control group: The study group (reduced-dose tacrolimus + standard-dose MMF)
or the control group (standard-dose tacrolimus + reduced-dose MMF). Restricted block
randomization was applied to this study and both the enrolled subjects and care providers
were blinded until randomization was done. A difference in the mean estimated glomerular
filtration rates (eGFR) of 16 mL/min/1.73m2 was considered a clinically meaningful margin of
non-inferiority. A sample size of 108 for both groups was calculated for the primary endpoint
by assuming a significance level of 0.025 with a power of at least 95% and adjusted for a
potential dropout rate of 20%.
The primary efficacy endpoint was the renal graft function assessed with eGFR by MDRD formula
at 6 months post-transplant. The secondary endpoints included (1) the incidence of treatment
failure that included biopsy-confirmed acute rejection (BCAR), graft loss, death, or loss to
follow-up until 6 months post-transplant; (2) recipients and grafts' survival rates; (3)
24-hour urine proteinuria and creatinine clearance at 6 months post-transplant. Recipients
with clinical findings suggestive of acute rejection underwent biopsies before initiation or
within 48 hours of anti-rejection therapy and biopsy specimens were graded according to Banff
Classification criteria.
Safety endpoints included (1) all adverse event defined as any medical occurrence including
worsening of a preexisting medical condition; (2) opportunistic infections; (3) malignancies;
(4) abnormal laboratory findings; and (5) any abnormal physical findings or vital signs.
Severe adverse events were defined as any adverse events with undesirable signs, symptoms, or
medical conditions that met any one of the following criteria: 1) was fatal or
life-threatening, 2) resulted in persistent or significant disability/incapacity, 3) required
hospitalization or the prolongation of existing hospitalization, 4) was a congenital
anomaly/birth defect, or 5) was an important medical event that might deteriorate the patient
and require medical or surgical intervention to prevent one of the other outcomes listed
above.18 All adverse events were coding using WHOART 2009 version.
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