Pharmacokinetics of LCP-Tacro in Stable Kidney Transplant Patients

• Status: Completed
• Trial end date: 2008-03-01
• Target enrollment: 0
• Participant gender: All

Summary

A three sequence, open-label, multi-center, prospective, study in stable kidney transplant patients to assess and compare the pharmacokinetics (Cmax, C24, and AUC), and safety of LCP-Tacro (tacrolimus) tablets versus Prograf (tacrolimus) capsules.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Veloxis Pharmaceuticals
• Collaborator: CTI Clinical Trial and Consulting Services
• Treatments: Tacrolimus

Criteria

Inclusion Criteria:

• Men and women 18-65 years of age who are recipients of a renal transplant at least 6 months prior to enrollment

• Patients on oral Prograf therapy as part of their maintenance immunosuppression therapy, with stable doses and trough levels of tacrolimus of 7-12 ng/mL for at least two weeks prior to enrollment.

• Patients maintained on concurrent immunosuppression with mycophenolate mofetil (MMF, CellCept) or mycophenolic acid delayed-release tablets (Myfortic), with stable doses for at least two weeks prior to enrollment

• Patients with serum creatinine < 2.0mg/dL prior to enrollment

• Able to swallow study medication

• Patients capable of understanding the purposes and risks of the study, who can give written informed consent and who are willing to participate in and comply with the study

• Women of childbearing potential must have a negative serum pregnancy test within seven days prior to receiving study medication

• Patients who successfully pass a drug screen

Exclusion Criteria:

• Recipients of any transplanted organ other than a kidney

• White blood cell count < 2.8 x 10^9 /L

• Patients who are receiving a total dose of Prograf for 24 hours < 3mg

• Patients unable or unwilling to provide informed consent

• Pregnant or nursing women

• Patients with reproductive potential who are unwilling/unable to use a double barrier method of contraception

• Administration of other investigational agent in the three months prior to enrollment

• Patient receiving any drug interfering with tacrolimus metabolism

• Patients who have taken sirolimus within the past three months prior to screening

• Patient with an episode of acute cellular requiring antibody therapy within the 6 months prior to enrollment

• Patient treated for acute cellular rejection within the 30 days prior to enrollment

• Patient who is HCV negative and has received an HCV positive (HCV RNA by PCR or HCV antibody) donor kidney

• Patient has 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

• Patient has uncontrolled concomitant infection, a systemic infection requiring treatment, or any other unstable medical condition that could interfere with the study objectives

• Patient has severe diarrhea, vomiting, active peptic ulcer or gastrointestinal disorder that may affect the absorption of tacrolimus

• Patient will require therapy with any immunosuppressive agent other than those prescribed in the study

• Patient has a known hypersensitivity to corticosteroids, mycophenolate mofetil, mycophenolic acid or tacrolimus

• Patient has any form of current substance abuse, psychiatric disorder or a condition that, in the opinion of the Investigator, may invalidate communication with the Investigator