Double-Blind,Double-Dummy,Efficacy/Safety,LCP-Tacro™ Vs Prograf®,Prevention Rejection,De Novo Adult Kidney Tx (LCPTacro3002)
Renal Failure
About this trial
This is an interventional prevention trial for Renal Failure focused on measuring Tacrolimus, Acute Rejection, Kidney
Eligibility Criteria
Inclusion Criteria:
- informed consent
- 18 and 70 years, inclusive
- receiving primary or secondary renal allograft from a deceased donor or non-human leukocyte antigen (HLA) identical living donor
- no known contraindications to the administration of IL-2 receptor antagonist induction therapy, MMF, corticosteroids or tacrolimus
- negative pregnancy test
- Negative cross match test, and compatible (A, B, AB or O) blood type
- Able to swallow tablets and capsules
Exclusion Criteria:
- Recipients of any non-renal transplant (solid organ or bone marrow) ever
- Panel reactive antibody (PRA) >30%
- Patients with any condition that may affect study drug absorption (e.g. gastrectomy or clinically significant diabetic gastroenteropathy)
- Body mass index (BMI) 18 kg/m2
- History of alcohol abuse
- History of recreational drug abuse
- Screening 12-lead electrocardiogram (ECG) demonstrating clinically relevant abnormalities
- WOCBP who are either pregnant, lactating, planning to become pregnant
- Patients with an oral temperature (prior to study drug dosing) of 38.0 ºC (100.4 ºF) or higher
- Patients with clinically significant active infections
- Patients with a known hereditary immunodeficiency
- Patients with malignancies or with a history of malignancies (within the last 5 years)
- Patients who are receiving or expect to receive sirolimus, everolimus, azathioprine,or cyclophosphamide within 3 months prior to enrollment
- Patients with evidence of clinically significant disease (e.g., cardiac, gastrointestinal or hepatic disorders)
- Patients with reversible cardiac ischemia (history of untreated reversible ischemia on stress test)
- Patients with clinically symptomatic congestive heart failure or documented ejection fraction of less than 45%
- Patients with significant chronic obstructive pulmonary disease, pulmonary restrictive disease or significant pulmonary hypertension
- Treatment with an investigational drug, device or regimen within 1 year preceding the first dose of study drug
- Patients who are unwilling to refrain from consumption of grapefruit or grapefruit containing juices
- Patients receiving concomitant drugs that may affect concentrations of tacrolimus in whole blood, as listed in Appendix 2
- Laboratory variables that are abnormal (outside laboratory reference range) and clinically relevant, as judged by the Investigator
- Patients with positive results of any of the following serological tests: human immunodeficiency virus (HIV)-1 antibody, hepatitis B virus (HBV) surface antigen (HBsAg), anti-hepatitis B core antibody (HBcAb), and anti-hepatitis C virus (HCV)antibody (HCV Ab).
- Patients who experienced graft loss within 1 year of transplant, due to acute rejection or due to BK nephropathy
- Patients having experienced focal segmental glomerulosclerosis (FSGS)
- Donor with positive serological test result for HIV-1, HBV or HCV
- Donor with history of malignant disease (current or historical)
- Centers for Disease Control and Prevention high-risk donor
- Patients with mental dysfunction or inability to cooperate with the study
- Cold ischemia time >30 hours
29. Non-heart-beating donor
Sites / Locations
- Clinical Site 1020
- Clinical Site 1031
- Clinical Site 1009
- Clinical Site 1022
- Clinical Site 1045
- Clinical Site 1049
- Clinical Site 1044
- Clinical Site 1011
- Clinical Site 1003
- Clinical Site 1036
- Clinical Site 1013
- Clinical Site 1038
- Clinical Site 1006
- Clinical Site 1055
- Clinical Site 1053
- Clinical Site 1056
- Clinical Site 1026
- Clinical Site 1052
- Clinical Site 1014
- Clinical Site 1018
- Clinical Site 1048
- Clinical Site 1037
- Clinical Site 1033
- Clinical Site 1060
- Clinical Site 1035
- Clinical Site 1042
- Clinical Site 1040
- Clinical Site 1050
- Clinical Site 1019
- Clinical Site 1025
- Clinical Site 1010
- Clinical Site 1051
- Clinical Site 1032
- Clinical Site 1058
- Clinical Site 1005
- Clinical Site 1054
- Clinical Site 1023
- Clinical Site 1021
- Clinical Site 1012
- Clinical Site 1047
- Clinical Site 1029
- Clinical Site 1061
- Clinical Site 1039
- Clinical Site 1027
- Clinical Site 1046
- Clinical Site 1008
- Clinical Site 54163
- Clinical Site 54164
- Clinical Site 61101
- Clinical Site 61105
- Clinical Site 61100
- Clinical Site 61104
- Clinical Site 61102
- Clinical Site 61106
- Clinical Site 55178
- Clinical Site 55172
- Clinical Site 55179
- Clinical Site 55175
- Clinical Site 55173
- Clinical Site 55171
- Clinical Site 33132
- Clinical Site 33131
- Clinical Site 33136
- Clinical Site 33134
- Clinical Site 49137
- Clinical Site 49139
- Clinical Site 39144
- Clinical Site 92113
- Clinical Site 52184
- Clinical Site 52181
- Clinical Site 52183
- Clinical Site 52182
- Clinical Site 64112
- Clinical Site 64121
- Clinical Site 48151
- Clinical Site 48148
- Clinical Site 48149
- Clinical Site 381140
- Clinical Site 381141
- Clinical Site 381142
- Clinical Site 65127
- Clinical Site 65126
- Clinical Site 34155
- Clinical Site 34157
- Clinical Site 34151
- Clinical Site 46161
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
LCP-Tacro
Prograf (tacrolimus)
The initial dose of 0.17 mg/kg will be administered orally in the morning (before noon) within 24 hours following transplantation. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels.
Starting total daily dose of 0.10 mg/kg administered in two equally divided doses, morning and evening, per product labeling. Doses will be adjusted according to whole blood tacrolimus trough levels. In the initial post-transplant period, plasma trough levels will be measured at 24 and 48 hours. Study drugs will be adjusted to maintain the whole blood pre-dose (trough) concentration of tacrolimus in the target range of 6 - 11 ng/mL for the first 30 days, then 4 - 11 ng/mL for the remainder of the study.