Standard- Versus Reduced-dose Tacrolimus Combined With Generic Mycophenolate Mofetil in De Novo Renal Transplantation
Condition: Disorder Related to Renal Transplantation
Study type: Interventional
Phase: Phase 4

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Tacrolimus(reduced), Mycophenolate mofetil(standard); Tacrolimus(standard), Mycophenolate mofetil(reduced)
Intervention type(s): Drug; Drug
Intervention description(s): tacrolimus target trough blood level: 3~8ng/mL MMF dose: 1.5~2g/d; tacrolimus target trough blood level: 5~15ng/mL MMF dose: 0.5~1g/d
Other intervention name(s): TacroBell, MY-REPT; TacroBell, MY-REPT
Intervention MeSH terms: Mycophenolic Acid; Tacrolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment