The purpose of this study is to confirm non-inferiority of delayed Prograf treatment to standard Prograf treatment in the incidence of delayed graft function (DGF) within 1 week between the 2 immunosuppressive (IS) treatment groups: delayed or standard Prograf together with induction therapy, and then convert to Advagraf usage in donation after cardiac (or circulatory) death (DCD) kidney transplant recipients. This study will also compare the clinical outcome within 6 month post-transplant between the 2 IS treatment groups and compare the safety throughout study period between the 2 IS treatment groups.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
284
oral
All participants will receive induction therapy. The dosage and administration of induction immunotherapy will be a single kind of drug determined by the investigator.
All participants will receive mycophenolic acid drugs in combination with corticosteroids. The dosage and administration of mycophenolic acid will be determined by the investigator.
All participants will receive corticosteroids in combination with mycophenolic acid drugs. The dosage and administration of corticosteroids will be determined by the investigator.
Site CN08608
Beijing, China
Site CN08619
Beijing, China
Site CN08609
Changsha, China
Site CN08604
Guangzhou, China
Site CN08614
Hangzhou, China
Site CN08617
Hangzhou, China
Site CN08610
Nanjing, China
Site CN08618
Nanjing, China
Site CN08612
Shanghai, China
Site CN08603
Tianjin, China
...and 4 more locations
Incidence of delayed graft function (DGF)
DGF is defined as dialysis requirement during the first post-transplant week (7 days).
Time frame: Up to Day 7 after transplantation
Incidence of acute rejection (AR)
The reporting of AR includes any biopsy-proven or clinically-suspected rejection of a subject after transplantation.
Time frame: Up to Month 6 after transplantation
Renal function assessed by estimated glomerular filtration rate (eGFR)
eGFR will be derived using the abbreviated Modification of Diet in Renal Disease (MDRD) formula.
Time frame: Up to Month 6 after transplantation
Renal function assessed by serum creatinine
Serum creatinine will be measured from serum sample collected.
Time frame: Up to Month 6 after transplantation
Renal function assessed by urea nitrogen
Urea nitrogen will be measured from serum sample collected.
Time frame: Up to Month 6 after transplantation
Subject survival
Subject survival is the time from the date of transplantation to the date of death or the date of the last follow-up. Subject survival will be estimated using Kaplan Meier estimates and compared by log rank test.
Time frame: Up to Month 6 after transplantation
Graft survival
Graft survival is an estimate of the probability of the transplant functioning at a finite time after transplantation. Graft survival will be calculated from the date of transplantation to the date of irreversible graft failure or the date of the last follow-up during the period when the transplant is still functioning or to the date of death.
Time frame: Up to Month 6 after transplantation
Safety assessed by incidence of treatment-emergent adverse events (TEAEs)
Adverse events (AEs) will be coded using the latest version of MedDRA. TEAE is defined as any AE following the transplantation until the end of the study.
Time frame: Up to Month 7 after transplantation
Safety assessed by incidence of serious adverse events (SAEs)
AE is considered "serious" if the investigator or sponsor view any of the following outcomes: Death, life-threatening, persistent or significant disability/incapacity, congenital anomaly or birth defect, hospitalization, or medically important event.
Time frame: Up to Month 7 after transplantation
Number of participants with laboratory test abnormalities and/or AEs
Number of participants with potentially clinically significant laboratory values.
Time frame: Up to Month 7 after transplantation
Number of participants with vital sign abnormalities and/or AEs
Number of participants with potentially clinically significant vital sign values.
Time frame: Up to Month 7 after transplantation
Number of participants with 12-lead electrocardiograms (ECG) abnormalities and/or AEs
ECG will be performed in the supine position after the subject has been breathing quietly for 5 minutes. Any clinically significant adverse changes on the ECG will be reported as AEs.
Time frame: Up to Month 7 after transplantation
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