pharmacokinetics of lcp-tacro in stable kidney transplant patients

Conditions: Renal Failure

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.

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. stable kidney transplant patients who fulfill all i/e criteria will be enrolled and kept on prograf for 7 days. following a 24-hour pk study on day 7 to determine pharmacokinetics for prograf, all patients will be converted to once daily lcp-tacro for 7 days with no dose changes allowed. on day 14 and day 21 a 24-hour lcp-tacro pk study will be performed. on day 22 patients will be converted back to their original twice daily dose of prograf for a safety follow-up period of 30 days ending with a safety assessment on day 53.

Eligibility 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

Keywords: tacrolimus pharmacokinetics kidney transplantation