ValidationNCT02377609
To Validate an Analytical Method to Measure Concentration of Tacrolimus in Blood Taken From Finger Pricks
An observational study of Validation and Dried Blood Spot, run by Astellas Pharma Europe Ltd. at 6 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Validation, Dried Blood Spot, Transplant Patients
- What is being tested?
- Tacrolimus
- Type of treatment
- Pill or oral medicine
- How many people
- 108 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Oct 2013to Sep 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Stable kidney or liver transplant recipient receiving Advagraf® (tacrolimus) therapy
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
France4 sites
Site: 7
Clichy, 92110
Site: 3
Paris, 75015
Site: 1
Toulouse, 31059
Site: 5
Villejuif, 94800
United Kingdom2 sites
Site: 2
Cambridge, CB2 0QQ
Site: 6
London, SE5 9RS
About this study
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
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.
Read the 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.
- Conditions
- Validation, Dried Blood Spot, Transplant Patients
- Being tested
- Tacrolimus
- Keywords
- Dry Blood Spot (DBS), Validation, Tacrolimus, Bioanalytical assay method cross-validation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TacrolimusDrug
Also called Advagraf, FK506E
oral
| Study group | Role | What they receive |
|---|---|---|
| Kidney or Liver Transplant Patients | adult kidney or liver Advagraf® (tacrolimus) recipients Receives: Drug: Tacrolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2015 (estimated)
- Study startOct 2013
- Primary completionSep 2014
- Study completionSep 2014
Why it stopped: DBS method not be validated against the standard of care venepuncture method due to quality of blood sample and variable tacrolimus extraction
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ValidationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Europe Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Astellas Pharma Europe Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02377609
- Sponsor's protocol ID
- PMR-EC-1215
- Other IDs
- 2013-002086-19
- Status last verified
- May 2015
- First submitted
- 26 Feb 2015
- Last updated
- 15 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02377609
- Acronym / sponsor ID
- PMR-EC-1215
- Conditions
- Validation, Dried Blood Spot, Transplant Patients
- Keywords
- Dry Blood Spot (DBS), Validation, Tacrolimus, Bioanalytical assay method cross-validation
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: DBS method not be validated against the standard of care venepuncture method due to quality of blood sample and variable tacrolimus extraction
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Astellas Pharma Europe Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 3 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case only
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Kidney or Liver Transplant Patients | – | Drug: Tacrolimusadult kidney or liver Advagraf® (tacrolimus) recipients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Stable kidney or liver transplant recipient receiving Advagraf® (tacrolimus) therapy
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TacrolimusAlso: Advagraf, FK506Eoral | Drug | Kidney or Liver Transplant Patients |
Primary outcome
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 secondary outcome
Compare estimated area under the curve (AUC) values of the DBS and whole blood assay methods using a Bayesian model
Time frame: 1 day
Results and safety
The study was stopped early (reason given: DBS method not be validated against the standard of care venepuncture method due to quality of blood sample and variable tacrolimus extraction). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Astellas Pharma Europe Ltd.
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Validation and Dried Blood Spot, run by Astellas Pharma Europe Ltd. at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: DBS method not be validated against the standard of care venepuncture method due to quality of blood sample and variable tacrolimus extraction). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2015; AzTrials last refreshed its copy on 6 Nov 2026.