Conversion From Brand to Generic Tacrolimus in High Risk Transplant Recipients

Inclusion criteria

• 18 years or older
• Able to participate and willing to give written informed consent/ assent/ consent by parent or legal guardian and to comply with the study visits and restrictions.
• Subject who has received a primary or secondary transplant.
• Subject who is at least 6 months post-transplant and on a stable dose of tacrolimus as defined by physician, one tacrolimus trough level within the physician defined target range within past 6 months and one additional trough level during the screening period within 30% of the physician defined target range.
• BMI less than or equal to 40.

Exclusion criteria

• Evidence of any acute rejection
• Subjects who require dialysis within 6 months prior to study entry
• Recipients of multiple organ transplants
• Subjects who have tested positive for HBsAG or HIV, or who are recipients of organ from donors who are known to be HBsAG or HIV positive. Virology screening at the time of transplant.
• HepC positive subjects with liver biopsy proven recurrent disease considered relevant by physician oversight.
• Subjects with any severe medical condition requiring acute or chronic treatment that in the investigator's opinion would interfere with study participation
• History of malignancy, treated or untreated, with the past 2 years with the exception of carcinoma in situ or excised basal cell carcinoma, or hepatocellular carcinoma prior to transplant.
• GFR ≤ 35 ml/min measured as estimated using the MDRD4 formula
• Subjects with AST, ALT, total bilirubin ≥ 3 X ULN or other evidence of severe liver disease
• Subjects with white blood cell (WBC) count ≤2,000/ mm3 or with thrombocytopenia (platelet count ≤ 75,000/ mm3), with an absolute neutrophil count of ≤ 1,500/ mm3 or hemoglobin 5 mIU/mL)
• Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are: 1) women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner; 2)women whose partners have been sterilized by vasectomy or 3)using a highly effective method of birth control (i.e. one that results in a less than 1% per year failure rate when used consistently and correctly, such as implants, injectables, combined oral contraceptives, and some intrauterine devices (IUDs); periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) is not acceptable.