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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Heart Transplantation, Lung Transplantation, Pancreas (Including SPK) Transplantation

Intervention / Treatment
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* Drug: Advagraf
* Drug: Prograf


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Advagraf<br> | Drug: Advagraf<br>* oral<br>* Other names: tacrolimus modified release;|
| Active Comparator: Prograf<br> | Drug: Prograf<br>* oral<br>* Other names: FK506;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| determine steady state systemic exposure (AUC 0-24h) |  | Day 1, Day 3, Day 7 and Day 42 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| determine Cmax (maximum concentration) |  | Day 1, Day 3, Day 7 and Day 42 | 
| determine tmax (time to attain Cmax) |  | Day 1, Day 3, Day 7 and Day 42 | 
| determine C24 (concentration prior to next morning dose) |  | Day 1, Day 3, Day 7 and Day 42 | 
| describe rejection episodes |  | up to 58 weeks | 
| describe subject survival |  | up to 58 weeks | 
| describe graft survival |  | up to 58 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Advagraf, Heart, Lung, Pancreas, Transplant, Immunosuppression, Pharmacokinetics