Status:
COMPLETED
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
Lead Sponsor:
Astellas Pharma Europe Ltd.
Conditions:
Kidney Transplantation
Liver Transplantation
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 bloo...
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 de...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 20 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 14 2018
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT03465969
Start Date
March 20 2018
End Date
September 14 2018
Last Update
October 15 2018
Active Locations (4)
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1
Site FR33002
Toulouse, France
2
Site FR33001
Villejuif, France
3
Site UK44002
Cambridge, United Kingdom
4
Site UK44001
London, United Kingdom