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The clinical validation of a dried blood spot method for immunosuppressive drugs and creatinine

The clinical validation of a dried blood spot method for immunosuppressive drugs and creatinine

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON23332
Enrollment
160
Registered
2020-04-02
Start date
2020-04-02
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Transplant recipients

Interventions

Patients are treated with tacrolimus, everolimus, sirolimus or ciclosporin, in the dose prescribed by their treating physician. In addition to the standard venous samples, DBS samples will be collecte

Sponsors

None
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria: - Unable to draw blood samples for study purposes

Design outcomes

Primary

MeasureTime frame
Optimizing the correction factor needed and clinically validating a DBS method for tacrolimus, everolimus, sirolimus, ciclosporin and creatinine.

Secondary

MeasureTime frame
- 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

Contacts

Public ContactBrenda de Winter

Erasmus Medical Center

b.dewinter@erasmusmc.nl+31107033202

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)