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

• Status: Completed
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc
• Treatments: Tacrolimus

Criteria

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