Phase 3
Completed N=543
Double-Blind,Double-Dummy,Efficacy/Safety,LCP-Tacro™ Vs Prograf®,Prevention Rejection,De Novo Adult Kidney Tx
Source: ClinicalTrials.gov NCT01187953 ↗Enrolled (actual)
543
Serious AEs
64.6%
Results posted
May 2015
Primary outcomePrimary: The Primary Efficacy Endpoint for the Study is the Proportion of Treatment Failures Within 12 Months After Randomization to Study Drug. — 8; 8; 9; 11 participants — p=>0.999
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 of organ rejection in newly transplanted adult kidney transplant recipients. Patients will be treated for a 12 month study period followed by a 12 month, blinded extension treatment period To show that LCP-Tacro Tablets are clinically similar to Prograf Capsules in the prevention of acute rejection.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Primary Efficacy Endpoint for the Study is the Proportion of Treatment Failures Within 12 Months After Randomization to Study Drug. |
8; 8; 9; 11; 35; 37 | >0.999 |
| SECONDARY For the 24-month Analysis, the Endpoint Includes Additional Treatment Failures That Occurred During the 12-month Treatment Extension Period, up to Day 734 After the Randomization Date. |
11; 13; 11; 15; 46; 50 | 0.835 |
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
- Non-heart-beating donor
Data sourced from ClinicalTrials.gov (NCT01187953). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.