Generic Tacrolimus in the Elderly - Prograf® vs Tacni®

Study Overview
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Brief Summary
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Test bioequivalence of generic tacrolimus (Tacni), using original tacrolimus (Prograf) as comparator, in elderly (>60 yr) renal transplant recipients

Detailed Description
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12-hour pharmacokinetic investigations performed on each formulation in each patient at steady-state. Patients will be randomized with regards to which formulation to start with. 1-2 weeks between each PK investigation.

Official Title
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Generic Tacrolimus in the Elderly - Prograf® vs Tacni®

Conditions
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End Stage Renal Disease

Intervention / Treatment
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* Drug: Tacrolimus
* Drug: Tacrolimus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Renal transplant recipients that will receive Tac as part of their immunosuppressive therapy. Recipients 60 years of age or older. Signed informed consent. Exclusion Criteria: Diabetes mellitus (WHO criteria). Concomitant treatment with: diltiazem, verapamil, phenytoin, carbamazepin, fluconazole, ketoconazole, voriconazole, erythromycin, clarithromycin.

Ages Eligible for Study
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Minimum Age: 60 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 |
| --- | --- |
| Experimental: Tacni<br>Tacrolimus administered as generic formulation Tacni in accordance with standard protocol at the transplant center | Drug: Tacrolimus<br>* Tested generic<br>* Other names: Tacrolimus formualted as the generic Tacni;Drug: Tacrolimus<br>* Original formulation used as comparator<br>* Other names: Tacrolimus formualted as the original Prograf;|
| Active Comparator: Prograf<br>Tacrolimus administered as Prograf in according to standard protocol at the transplant center | Drug: Tacrolimus<br>* Tested generic<br>* Other names: Tacrolimus formualted as the generic Tacni;Drug: Tacrolimus<br>* Original formulation used as comparator<br>* Other names: Tacrolimus formualted as the original Prograf;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence | Bioequivalence will be assessed at steady-state by comparing both AUC(0-12) and Cmax ratios for generic:original-ratios and applying the stricter 90-111% bioequivalence criteria. AUC(0-12) will be assessed by trapezoidal rule and Cmax will be the highest actually measured concentration. | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Population model validation | Use these new patient data to verify previously developed population pharmacokinetic model for tacrolimus. | 10 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Renal, Transplantation, Elderly