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

Astellas

Status and phase: Completed; Phase 4

Conditions: Liver Transplantation; Kidney Transplantation

Treatments: Drug: tacrolimus

Study type: Interventional

Funder types: Industry

Identifiers

NCT03465969

2017-004121-33 (EudraCT Number)

506-MA-3189

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 1 patient group

Liver or kidney transplant participants of Advagraf

Other group

Description:

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.

Treatment:

Drug: tacrolimus