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

Sponsor

Astellas Pharma Europe Ltd. (Industry)

Overall Status

Terminated

CT.gov ID

NCT02377609

Collaborator

(none)

108

Enrollment

Locations

Duration (Months)

Patients Per Site

1.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Validation Dried Blood Spot Transplant Patients	Drug: Tacrolimus

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 Design

Study Type:

Observational

Actual Enrollment :

108 participants

Observational Model:

Case-Only

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

Study Start Date :

Oct 1, 2013

Actual Primary Completion Date :

Sep 1, 2014

Actual Study Completion Date :

Sep 1, 2014

Arms and Interventions

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

Arm

Intervention/Treatment

Kidney or Liver Transplant Patients

adult kidney or liver Advagraf® (tacrolimus) recipients

Drug: Tacrolimus

oral

Other Names:

Advagraf

FK506E

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Site: 7	Clichy	France	92110
2	Site: 3	Paris	France	75015
3	Site: 1	Toulouse	France	31059
4	Site: 5	Villejuif	France	94800
5	Site: 2	Cambridge	United Kingdom	CB2 0QQ
6	Site: 6	London	United Kingdom	SE5 9RS