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.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
determine steady state systemic exposure (AUC 0-24h)