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

NCT03465969 — Phase 4, Completed, 80 participants, Astellas Pharma Europe Ltd.

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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

Registry	NCT03465969, acronym MITRA
Status	Completed
Phase	Phase 4
Study type	Interventional; na, single group, masking: none, other
Enrollment	80 (Actual)
Sponsor	Astellas Pharma Europe Ltd. (Industry)
Conditions	Kidney Transplantation, Liver Transplantation
Interventions	tacrolimus (Drug)
Dates	start 2018-03-20, primary completion 2018-09-14, completion 2018-09-14, first posted 2018-03-15, last updated 2018-10-15
Locations	4 sites in France, United Kingdom

-Summary

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.

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+Detailed description

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.

+Arms and interventions

Arm	Type	Interventions	Description
Liver or kidney transplant participants of Advagraf	Other	Drug: tacrolimus	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.

tacrolimus (Drug), also known as Advagraf: oral

+Outcome measures

Primary outcomes

Comparison of blood concentrations of tacrolimus [Day 1]: 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.

+Eligibility

Sex: All, ages: 18 Years to any

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.

+Locations (4)

Facility	City	Country
Site FR33002	Toulouse	France
Site FR33001	Villejuif	France
Site UK44002	Cambridge	United Kingdom
Site UK44001	London	United Kingdom

+Investigators

Clinical Research Physician, Study director, Astellas Pharma Europe Ltd.

+Funding

NIH grants: 2017

My Notes

Public

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