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

• Status: Completed
• Trial end date: 2018-09-14
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Europe Ltd.
• Treatments: Tacrolimus

Criteria

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.