Immunosuppressive drug
Conditions
Interventions
None listed
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The intracellular tacrolimus concentration in CD3+ T lymphocytes and a population pharmacokinetic model to describe tacrolimus. | — |
Secondary
| Measure | Time frame |
|---|---|
| The association between the intracellular tacrolimus concentration in CD3+ T lymphocytes and IL-2 and IFN-* production by these same cells. The association between the intracellular tacrolimus concentration in CD3+ T lymphocytes and clinical events (post-transplant diabetes mellitus and acute rejection). | — |
Countries
Netherlands
Outcome results
None listed