A Study to Compare the Finger Prick Whole Blood MITRA Assay Method With the Established Venepuncture Whole Blood Method for Quantitative Determination of Tacrolimus Blood Concentrations in Transplant Patients

Study Overview
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Brief Summary
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The purpose of this study is to assess relationship between tacrolimus concentrations determined via whole blood MITRA assay method with those determined using the established and validated whole blood venepuncture method using samples taken from liver and kidney transplant participants.

Detailed Description
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This will be a bioanalytical assay method cross-validation study using blood samples donated by liver or kidney transplant participants. Participants will have been on a stable dose of Advagraf and deemed clinically stable for a period of 3-6 months and attend a routine out-patient follow-up visit to receive their usual oral dose of commercial Advagraf. Participants will be asked to provide 1 whole blood venepuncture sample and 1 whole blood finger prick MITRA sample at pre-dose and at approximately 1 and 3 hours post-dose. Participants will be kept at the study site for an extra 1 hour to ensure post-sampling safety and will be discharged thereafter.

Official Title
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A Bioanalytical Method Cross-validation Study to Compare the Finger Prick Whole Blood MITRA Assay Method With the Established Venepuncture Whole Blood Method for Quantitative Determination of Tacrolimus Blood Concentrations in Transplant Patients

Conditions
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Kidney Transplantation, Liver Transplantation

Intervention / Treatment
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* Drug: tacrolimus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject will be a recipient of either a liver or kidney transplant and on a stable dose of commercial Advagraf minimum of 3 months. Subjects will be with clinically stable graft function for at least 3 months. Exclusion Criteria: Subjects who are still participating in another clinical study or who have participated in a clinical study involving administration of an investigational drug in the past 3 months.

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: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Liver or kidney transplant participants of Advagraf<br>Transplant participants will provide 1 whole blood venepuncture sample and 1 whole blood finger prick MITRA sample at pre-dose of participant's usual oral dose of commercial Advagraf and at approximately 1 and 3 hours post-dose. | Drug: tacrolimus<br>* oral<br>* Other names: Advagraf;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of blood concentrations of tacrolimus | Tacrolimus concentrations will be determined from the dried whole blood samples collected via finger prick into MITRA cartridge and in whole blood taken by venipuncture. | Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Kidney transplantation, A Bioanalytical Method Cross-validation, Advagraf, Liver transplantation