Status:
COMPLETED
Pharmacokinetics of LCP-Tacro(TM) Once Daily And Prograf® Twice A Day in Adult De Novo Kidney Transplant Patients
Lead Sponsor:
Veloxis Pharmaceuticals
Collaborating Sponsors:
CTI Clinical Trial and Consulting Services
Aptuit
Conditions:
Kidney Failure
Renal Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to demonstrate the pharmacokinetics (PK, measuring the amount of medication in blood samples) and safety of a new medicine, LCP-Tacro™ tablets, and Prograf® capsules, a dr...
Detailed Description
This study was a randomized, parallel-group, open label, multicenter study in adult de novo kidney transplant patients to demonstrate the pharmacokinetics and safety of LCP-Tacro tablets and Prograf c...
Eligibility Criteria
Inclusion
- Adult men and women at least 18 years of age who are recipients of a kidney transplant from a deceased donor or a live donor and who receive their first oral dose of randomized study drug within 48 hours of the transplant surgery (graft reperfusion)
Exclusion
- Recipient of any transplanted organ other than a kidney
- Recipients of a kidney from a non-heart beating donor
- Recipients of a kidney from an ABO incompatible donor
- Recipients of a kidney with a cold ischemia time of ≥ 36 hours
- Recipients of a bone marrow or stem cell transplant
- Patients with a white blood cell count ≤ 2.8 x 109/L unless the absolute neutrophil count (ANC) is \> 1.0 x 109/L
- Patients with aspartate aminotransferase (AST) or alanine aminotransferase (ALT) enzyme levels \> 3 times the upper limit of normal during the 30 days prior to the transplant procedure
- Patients who fail a drugs of abuse screen
- Patients unable to swallow study medication
- Patients incapable of understanding the purposes and risks of the study, who cannot give written informed consent, or who are unwilling to comply with the study protocol
- Pregnant or nursing women (women of childbearing potential must have a negative serum pregnancy test within seven days prior to receiving study medication)
- Patients with reproductive potential who are unwilling/unable to use a double barrier method of contraception throughout the duration of the study
- Patients who were treated with any other investigational agent in the 30 days prior to enrollment
- Patients who are hepatitis C virus (HCV) negative who have received a HCV positive (HCV RNA by polymerase chain reaction (PCR) or HCV antibody) donor kidney
- Patients seropositive for human immunodeficiency virus (HIV)
- Patients with a current malignancy or a history of malignancy (within the past 5 years), except basal or non-metastatic squamous cell carcinoma of the skin that has been treated successfully
- Patients with uncontrolled concomitant infection, a systemic infection requiring treatment, or any other unstable medical condition that could interfere with the study objectives
- Patients with severe diarrhea, vomiting, active peptic ulcer or gastrointestinal disorder that may affect the absorption of tacrolimus
- Patients with a known hypersensitivity to tacrolimus
- Patients with any form of current substance abuse, psychiatric disorder or a condition that, in the opinion of the Investigator, may invalidate communication with the investigator
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT00765661
Start Date
September 1 2008
End Date
February 1 2010
Last Update
May 19 2015
Active Locations (1)
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1
University of Cincinnati
Cincinnati, Ohio, United States, 45267