Study to Compare the Pharmacokinetics of Tacrolimus in Adult Transplant Recipients Treated With Advagraf® or Prograf®

A Phase II, Open Label, Parallel Group, Multi-center Study to Compare the Pharmacokinetics of Tacrolimus in Adult Subjects Undergoing Primary Allograft Transplantation Receiving an Advagraf® or Prograf® Based Immunosuppressive Regimen, Including a Long-term Follow-up

Comparison of tacrolimus blood levels in adults who have received a transplant and are taking either Prograf or Advagraf anti-rejection therapy immediately following surgery. This is followed by checking of safety and effectiveness for one year.

Inclusion Criteria:

• must receive first oral dose of tacrolimus one day (lung, pancreas or Simultaneous Pancreas Kidney (SPK) recipients) or three days (heart recipients) after transplantation (skin closure)
• negative pregnancy test prior to enrolment (females)
• agree to practice effective birth control during the study
• treated since transplantation with Antithymocyte globulin/ Mycophenolate Mofetil/steroids (ATG/MMF/steroids), gastric motility resumed and renal function adequate (<230 µmol/l (<2.6 ml/dl)) on Day 1

Exclusion Criteria:

• receiving a multi-organ transplant (with the exception of SPK) or previously received an organ transplant (including re-transplantation)
• pulmonary vascular resistance ≥4 Wood units despite medication
• required an emergency ventricular assist device within one week prior to transplantation
• significant renal impairment
• significant liver disease
• malignancies or a history of malignancy within the last 5 years
• significant, uncontrolled concomitant infections and/or severe diarrhoea, vomiting, active upper gastrointestinal disorder that may affect the absorption of tacrolimus, or active peptic ulcer
• requires systemic immunosuppressive medication for any other indication than transplantation
• diagnosis of cystic fibrosis
• pregnant or breast-feeding