To Validate an Analytical Method to Measure Concentration of Tacrolimus in Blood Taken From Finger Pricks

Astellas Pharma Europe Ltd.108 enrolled

Overview

The principal aim of this study is to define the relationship between tacrolimus concentrations determined from the finger prick DBS (Dry Blood Spot) method and those determined from blood samples collected by venepuncture in transplant recipients.

This will be a bioanalytical assay method cross-validation study using blood samples donated by up to 100 liver and 100 kidney transplant patients. Subjects who will be attending a routine outpatient follow-up visit will be asked to provide 3 whole blood venepuncture samples (each sample = 3 mL blood) and 3 finger prick DBS blood samples at predose and at 1 and 3 hours postdose. All subjects will be discharged from the study and clinical site at 3 hours postdose. Subjects will derive no benefit from the blood collection procedures and will be paid a predetermined stipend for participating in the study.

Study Type

OBSERVATIONAL

Enrollment

108

Conditions

Validation Dried Blood Spot Transplant Patients

Interventions

TacrolimusDRUG

oral

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Stable adult transplant recipients aged ≥ 18 years maintained on a once daily Advagraf® based immunosuppressive regimen for the prophylaxis of kidney or liver allograft rejection. Exclusion Criteria: * Subjects who are still participating in another clinical study (e.g. attending follow up visits) or who have participated in a clinical study involving administration of an investigational drug (new chemical entity) in the past 3 months.

Locations (6)

Site: 7

Clichy, France

Site: 3

Paris, France

Site: 1

Toulouse, France

Site: 5

Villejuif, France

Site: 2

Cambridge, United Kingdom

Outcomes

Primary Outcomes

Cross-validate the dried blood spot (DBS) method by defining the relationship between tacrolimus concentrations determined via DBS method, with those determined using the established and validated whole blood method

Time frame: 1 day

Secondary Outcomes

Compare estimated area under the curve (AUC) values of the DBS and whole blood assay methods using a Bayesian model

Time frame: 1 day

Data from ClinicalTrials.gov

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