Status:
COMPLETED
Double-Blind,Double-Dummy,Efficacy/Safety,LCP-Tacro™ Vs Prograf®,Prevention Rejection,De Novo Adult Kidney Tx
Lead Sponsor:
Veloxis Pharmaceuticals
Conditions:
Renal Failure
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
This study will evaluate the efficacy and safety of LCP-Tacro (tacrolimus) Tablets administered once-a-day compared to Prograf (tacrolimus) Capsules twice-a-day as immunosuppression for the prevention...
Detailed Description
This is a two-armed parallel group, prospective, randomized, double-blind, double-dummy,multicenter Phase 3 clinical study to establish the efficacy and safety of LCP-Tacro Tablets (tacrolimus, LifeCy...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
543 Patients enrolled
Trial Details
Trial ID
NCT01187953
Start Date
September 1 2010
End Date
March 1 2014
Last Update
May 18 2016
Active Locations (86)
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1
Clinical Site 1020
Birmingham, Alabama, United States, 35294
2
Clinical Site 1031
Loma Linda, California, United States, 92354
3
Clinical Site 1009
Los Angeles, California, United States, 90024
4
Clinical Site 1022
Sacremento, California, United States, 95817