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

Astellas

Status: Terminated

Conditions: Transplant Patients; Validation; Dried Blood Spot

Treatments: Drug: Tacrolimus

Study type: Observational

Funder types: Industry

Identifiers

NCT02377609

PMR-EC-1215

2013-002086-19 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 108 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

108 participants in 1 patient group

Kidney or Liver Transplant Patients

Description:

adult kidney or liver Advagraf® (tacrolimus) recipients

Treatment:

Drug: Tacrolimus