To prove non-inferiority of MR4 to Prograf by evaluating the efficacy and safety of Prograf and MR4 in new kidney transplant recipients
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
135
Unnamed facility
Daegu, South Korea
Unnamed facility
Seoul, South Korea
Acute rejection within 24 weeks (6 months)
Time frame: 6 months
Incidence of biopsy-proven acute rejection (Banff Grade ≥ 1)
Time frame: at 6 months
Time to first acute rejection episode
Time frame: for 6 months
6 month patient and graft survival rate
Time frame: at 6 months
Severity of acute rejection
Time frame: 6 months
Adverse events, laboratory parameters and vital signs
Time frame: Throughout trial
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