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

Validation Clinical Trial

Official title:

Cross-validation of the Finger Prick Dried Blood Spot Assay Method With the Established Whole Blood Method for Quantitative Determination of Tacrolimus Blood Concentrations in Transplant Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02377609
• Other study ID #: PMR-EC-1215
• Secondary ID: 2013-002086-19
• Status: Terminated
• Phase: N/A
• First received: February 26, 2015
• Last updated: May 14, 2015
• Start date: October 2013
• Est. completion date: September 2014

Study information

• Verified date: May 2015
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 108
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case-Only

Related Conditions & MeSH terms

• Dried Blood Spot
• Transplant Patients
• Validation

Intervention

Drug:
• Tacrolimus
oral

Locations

Country	Name	City	State
France	Site: 7	Clichy
France	Site: 3	Paris
France	Site: 1	Toulouse
France	Site: 5	Villejuif
United Kingdom	Site: 2	Cambridge
United Kingdom	Site: 6	London

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Europe Ltd.

Countries where clinical trial is conducted

France,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Compare estimated area under the curve (AUC) values of the DBS and whole blood assay methods using a Bayesian model		1 day	No