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

Terminated

• Conditions: Validation; Dried Blood Spot; Transplant Patients
• Interventions: Drug: Tacrolimus

• Registration Number: NCT02377609
• Lead Sponsor: Astellas Pharma Europe Ltd.

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2013-10
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Study First Submitted: 2015-02-26
• Study First Submitted QC: 2015-02-26
• Study First Posted: 2015-03-03
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-14
• Last Update Posted: 2015-05-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 108

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Kidney or Liver Transplant Patients	Tacrolimus	adult kidney or liver Advagraf® (tacrolimus) recipients

Primary Outcome Measures

Name	Time	Method
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	1 day

Secondary Outcome Measures

Name	Time	Method
Compare estimated area under the curve (AUC) values of the DBS and whole blood assay methods using a Bayesian model	1 day

Trial Locations

Locations (6)

Site: 6; 🇬🇧 London, United Kingdom

Site: 7; 🇫🇷 Clichy, France

Site: 3; 🇫🇷 Paris, France

Site: 1; 🇫🇷 Toulouse, France

Site: 5; 🇫🇷 Villejuif, France

Site: 2; 🇬🇧 Cambridge, United Kingdom