The intracellular pharmacokinetics of tacrolimus in CD3+ T lymphocytes

Completed

• Conditions: Immunosuppressive drug; 10038430

• Registration Number: NL-OMON51867
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-11-30
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 31

Inclusion Criteria

- Age * 18 years.
- Recipient of a kidney transplant at the Erasmus MC.
- Use once-daily tacrolimus as part of routine maintenance immunosuppression
starting the day of surgery.
- Written informed consent.

Exclusion Criteria

Patients who receive lymphocyte depleting agents (thymoglobuline,
anti-thymocyte globulin, and alemtuzumab) as an induction therapy or
anti-rejection treatment before enrolment. Recipients using medication known to
have a pharmacokinetic (drug-drug) interaction with tacrolimus: Antibiotics
(Clarithromycin, Doxycyclin, Erythromycin, Rifampicin), Antiepileptics
(Carbamazepine, Phenobarbital, Phenytoin), Antihypertensive and antiarrhythmic
agents (Amiodarone, Diltiazem, Verapamil), Antimycotic drugs (Fluconazole,
Itraconazole, Ketoconazole), Other (HIV protease inhibitors, Theophyllin)

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified