The objective of this study is to clinically validate a DBS method for immunosuppressive drugs and creatinine, using a LC-MS/MS method.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Transplantatie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Correlation between the DBS concentrations and venous blood concentrations of
immunosuppressive drugs and creatinine.
Secondary outcome
- Analyzing the differences in the measured concentrations in the dried blood
spot made with blood obtained from venous sampling and capillary sampling.
- Evaluating the need of a correction factor when measuring the hematocrit in
the DBS samples
- Analyzing the difference between the drug concentration in the microtainer
and filtrate card, to investigate the influence of the filtrate card on the
drug concentration
Background summary
Transplant rejections can occur when a patient is not properly adjusted on
immunosuppressive drugs. To ensure adequate exposure to immunosuppressive
drugs, drug doses are adjusted based on whole-blood concentration measurements,
a practice known as therapeutic drug monitoring (TDM). A sampling method for
TDM that has become more popular over the recent years is dried blood spotting
(DBS). Unlike venous blood sampling (the current gold standard for TDM
immunosuppressive drugs), DBS seems to have advantages for the patient. Due to
the fact that the cornerstone of immunosuppression, tacrolimus, everolimus,
sirolimus and ciclosporin are nephrotoxicity and are prescribed to maintain
adequate kidney transplant function, it would be very efficient and convenient
to measure creatinine in the same dried blood spot as the immunosuppressants.
This method uses less blood volume and can be applied at home by the patient
himself.
Study objective
The objective of this study is to clinically validate a DBS method for
immunosuppressive drugs and creatinine, using a LC-MS/MS method.
Study design
Cross-sectional observational study.
Study burden and risks
Participants will undergo one fingerprick (approximately 550 microliters blood
will be drawn), which causes mild irritation, and are asked to fill in a short
questionnaire.
An additional cohort of n=20 patients will be included to validate the
correction formula for tacrolimus. These patients will undergo one fingerprick.
An additional cohort of n=80 patients will be included to validate the
optimized method of tacrolimus and cyclosporine. These patients will undergo
one fingerprick.
In future, this DBS method can be used in clinical practice, which uses less
blood volume for therapeutic drug monitoring and can be applied by the patient
at home.
Dr.Molewaterplein 40
Rotterdam 3015 GD
NL
Dr.Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
- Aged 18 and over
- Able to understand written information and able to give informed consent
- Treated with tacrolimus, everolimus, sirolimus and/or ciclosporin
- Able and willing to undergo a finger prick for dried blood spot sampling
- Able and willing to fill in a questionnaire
Exclusion criteria
Unable to draw blood samples for study purposes
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL72082.078.19 |