A randomized controlled trial comparing Dried Blood Spot sampling to venous sampling for Therapeutic Drug Monitoring in tacrolimus using kidney transplant patients: a cost minimization analysis.

A randomized controlled trial comparing Dried Blood Spot sampling to venous sampling for Therapeutic Drug Monitoring in tacrolimus using kidney transplant patients: a cost minimization analysis. - Cost minimization analysis of Dried Blood Spots

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON43269

Enrollment

Registered

2016-05-17

Start date

2016-10-11

Completion date

Unknown

Last updated

2025-03-24

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

Conditions

Niertransplantatie Kidney transplantation Solid organ transplantation

Interventions

Depending on randomization: - Performing the Dried Blood Spots sampling method at home (DBS-group) - Use conventional whole blood sampling at the UMCG (control-group) - Filling in a questionnaire

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Age 18 years or older Use tacrolimus Received a kidney transplant in the UMCG and are still hospitalized Speak the Dutch language Are able to use the DBS sampling method

Exclusion criteria

Exclusion criteria: Not able to use the DBS method Not able to speak the dutch language

Design outcomes

Primary

Measure	Time frame
Amount of patient visits to the policlinic of the UMCG for a scheduled check-up as reported in the Electronic Patient Dossier (EPD).	—

Secondary

Measure	Time frame
•Prescriptions written and printed for the immunosuppressant tacrolimus and given to the patient and/or faxed to the community pharmacy and/or general practitioner. •Time spent by the nephrologist preparing and finishing a patients* visit at the policlinic including phone calls. •Intra individual variation in tacrolimus trough blood concentration between the DBS and non-DBS group •Loss in worktime for attending check-ups at the policlinic of the UMCG •Satisfaction and feasability of DBS	—

Measure

Time frame

•Prescriptions written and printed for the immunosuppressant tacrolimus and given to the patient and/or faxed to the community pharmacy and/or general practitioner. •Time spent by the nephrologist preparing and finishing a patients* visit at the policlinic including phone calls. •Intra individual variation in tacrolimus trough blood concentration between the DBS and non-DBS group •Loss in worktime for attending check-ups at the policlinic of the UMCG •Satisfaction and feasability of DBS

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)