Clinical trial NCT00496483 (phase 2, status: completed)
Conditions: renal failure
ICD codes: P96.0, O03.32, O04.82, O08.4, O03.82, O07.32, I13.11
Drugs: lcp tacro (tacrolimus), prograf
SMILES: CO[C@@H]1C[C@@H](CC[C@H]1O)\C=C(/C)[C@H]1OC(=O)[C@@H]2CCCCN2C(=O)C(=O)[C@]2(O)O[C@@H]([C@H](C[C@H]2C)OC)[C@H](C[C@@H](C)C\C(C)=C\[C@@H](CC=C)C(=O)C[C@H](O)[C@H]1C)OC, CO[C@@H]1C[C@@H](CC[C@H]1O)\C=C(/C)[C@H]1OC(=O)[C@@H]2CCCCN2C(=O)C(=O)[C@]2(O)O[C@@H]([C@H](C[C@H]2C)OC)[C@H](C[C@@H](C)C\C(C)=C\[C@@H](CC=C)C(=O)C[C@H](O)[C@H]1C)OC
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