Advagraf/Prograf Conversion Trial

Study Overview
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Brief Summary
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Renal and kidney pancreas transplant patients will be randomized to once daily Advagraf or twice daily Prograf to assess changes in tacrolimus and mycophenolate mofetil exposure, renal allograft function, other relevant biochemical parameters and treatment related adverse effects.

Official Title
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A Randomized, Open Label, Cross Over Study to Examine the Impact of Prograf and Advagraf on Tacrolimus Exposure, Mycophenolic Acid Pharmacokinetics, Renal Allograft Function or Adverse Effects.

Conditions
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Renal Transplant, Kidney Pancreas Transplant

Intervention / Treatment
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* Drug: Tacrolimus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Renal transplant or Renal Pancreas patients who are > 12 months post transplant Stable allograft function defined as eGFR > 30-60ml/min Renal patients who have a stable tacrolimus trough level of 5-8ng/ml in prior 3 months; Renal pancreas patients who have a stable tacrolimus trough level of 3-10 mg/ml in prior 3 months Receiving concomitant therapy with mycophenolate mofetil in a dose of 500-1000mg bid or equivalent Exclusion Criteria: Any surgical or medical condition, which in the opinion of the investigator, may place the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study. History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin. Treated rejection within 3 months of randomization. Increased serum creatinine > 20% within 3 months of randomization. Subject is pregnant or breastfeeding Subject has significant co-morbid disease (eg. Malignancy or uncontrolled infection) or disability (e.g. cognitive deficit) which prevents understanding of, or adherence to, the protocol

Ages Eligible for Study
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Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Advagraf<br> | Drug: Tacrolimus<br>* tacrolimus extended release capsules vs Prograf<br>|
| Active Comparator: Prograf<br> | Drug: Tacrolimus<br>* tacrolimus extended release capsules vs Prograf<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| renal function |  | baseline to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence of MPA exposure with Advagraf | Bioequivalence is measured using Pharmacokinetic monitoring of MPA plasma concentrations. | Baseline, 12 weeks and 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Renal, Kidney/Pancreas, Transplant, conversion, bioequivalence, Mycophenolate Acid