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

Phase 4

Completed

• Conditions: Liver Transplantation; Kidney Transplantation
• Interventions: Drug: tacrolimus

• Registration Number: NCT03465969
• Lead Sponsor: Astellas Pharma Europe Ltd.

Brief 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.

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.

Study Timeline

• Study First Submitted: 2018-02-21
• Study First Submitted QC: 2018-03-08
• Study First Posted: 2018-03-15
• Study Start: 2018-03-20
• Primary Completion: 2018-09-14
• Study Completion: 2018-09-14
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-12
• Last Update Posted: 2018-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Liver or kidney transplant participants of Advagraf	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (4)

Site FR33002; 🇫🇷 Toulouse, France

Site FR33001; 🇫🇷 Villejuif, France

Site UK44001; 🇬🇧 London, United Kingdom

Site UK44002; 🇬🇧 Cambridge, United Kingdom