Study Stopped
DBS method not be validated against the standard of care venepuncture method due to quality of blood sample and variable tacrolimus extraction
To Validate an Analytical Method to Measure Concentration of Tacrolimus in Blood Taken From Finger Pricks
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
2 other identifiers
observational
108
2 countries
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2013
Shorter than P25 for all trials
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedFirst Submitted
Initial submission to the registry
February 26, 2015
CompletedFirst Posted
Study publicly available on registry
March 3, 2015
CompletedMay 15, 2015
May 1, 2015
11 months
February 26, 2015
May 14, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Compare estimated area under the curve (AUC) values of the DBS and whole blood assay methods using a Bayesian model
1 day
Study Arms (1)
Kidney or Liver Transplant Patients
adult kidney or liver Advagraf® (tacrolimus) recipients
Interventions
Eligibility Criteria
Stable kidney or liver transplant recipient receiving Advagraf® (tacrolimus) therapy
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Site: 7
Clichy, 92110, France
Site: 3
Paris, 75015, France
Site: 1
Toulouse, 31059, France
Site: 5
Villejuif, 94800, France
Site: 2
Cambridge, CB2 0QQ, United Kingdom
Site: 6
London, SE5 9RS, United Kingdom
Biospecimen
Dried blood spot and blood collected by venepuncture
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Astellas Pharma Europe Ltd.
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 26, 2015
First Posted
March 3, 2015
Study Start
October 1, 2013
Primary Completion
September 1, 2014
Study Completion
September 1, 2014
Last Updated
May 15, 2015
Record last verified: 2015-05