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

May 14, 2015 updated by: Astellas Pharma Europe Ltd.

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

108

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clichy, France, 92110
        • Site: 7
      • Paris, France, 75015
        • Site: 3
      • Toulouse, France, 31059
        • Site: 1
      • Villejuif, France, 94800
        • Site: 5
  • United Kingdom
      • Cambridge, United Kingdom, CB2 0QQ
        • Site: 2
      • London, United Kingdom, SE5 9RS
        • Site: 6

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Stable kidney or liver transplant recipient receiving Advagraf® (tacrolimus) therapy

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Kidney or Liver Transplant Patients
adult kidney or liver Advagraf® (tacrolimus) recipients
Drug: Tacrolimus
oral
Other Names:
  • Advagraf
  • FK506E

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
1 day

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Europe Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

February 26, 2015

First Submitted That Met QC Criteria

February 26, 2015

First Posted (Estimate)

March 3, 2015

Study Record Updates

Last Update Posted (Estimate)

May 15, 2015

Last Update Submitted That Met QC Criteria

May 14, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PMR-EC-1215
  • 2013-002086-19 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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