Double-Blind,Double-Dummy,Efficacy/Safety,LCP-Tacro™ Vs Prograf®,Prevention Rejection,De Novo Adult Kidney Tx

Completed · Phase 3

Conditions studied: Renal Failure

In brief

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.

Key facts

Study ID

NCT01187953

Run by

Veloxis Pharmaceuticals

People needed

543

Starts

2010-09-01

Expected to finish

2014-03-01

Last updated by the study team

2016-05-18

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Clinical Site 1031 — Loma Linda, California, United States
• Clinical Site 1009 — Los Angeles, California, United States
• Clinical Site 1022 — Sacremento, California, United States
• Clinical Site 1045 — San Diego, California, United States
• Clinical Site 1049 — San Diego, California, United States
• Clinical Site 1044 — San Francisco, California, United States
• Clinical Site 1011 — Denver, Colorado, United States
• Clinical Site 1003 — New Haven, Connecticut, United States
• Clinical Site 1036 — Gainesville, Florida, United States
• Clinical Site 1013 — Miami, Florida, United States
• Clinical Site 1038 — Orlando, Florida, United States
• Clinical Site 1006 — Tampa, Florida, United States
• Clinical Site 1055 — Atlanta, Georgia, United States
• Clinical Site 1053 — Chicago, Illinois, United States
• Clinical Site 1056 — Peoria, Illinois, United States
• Clinical Site 1026 — New Orleans, Louisiana, United States
• Clinical Site 1052 — Portland, Maine, United States
• Clinical Site 1014 — Boston, Massachusetts, United States
• Clinical Site 1018 — Detroit, Michigan, United States
• Clinical Site 1048 — Hackensack, New Jersey, United States
• Clinical Site 1037 — Livingston, New Jersey, United States
• Clinical Site 1033 — New Brunswick, New Jersey, United States
• Clinical Site 1060 — Albany, New York, United States
• Clinical Site 1042 — Buffalo, New York, United States
• Clinical Site 1020 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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