Prophylaxis of the rejection of an allogeneic organ Immunosuppression
Conditions
Interventions
None listed
Sponsors
Centre for Human Drug Research
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Signed informed consent prior to any study-mandated procedure - Male or female kidney transplantation patients >18 years of age (inclusive) - Patients that have undergone a kidney transplantation > 2 years before study start - Patients on maintenance immunosuppression with low-dose prednisolone, MMF and tacrolimus adjusted to target trough levels. - Patients that have the ability to communicate well with the Investigator in the Dutch language and willing to comply with the study restrictions
Exclusion criteria
Exclusion criteria: - The use of any medication other than the patient*s standard treatment within less than 5 half-lives prior to study participation, if the investigator judges that it may interfere with the study objectives; - The use of immunosuppressive or immunomodulatory medication, other than the patient*s standard treatment, within 3 months before study participation, if the investigator judges that it may interfere with the study objectives; - Any known factor, condition, or disease that might interfere with study conduct or interpretation of the results, in the opinion of the investigator. - Unwillingness or inability to comply with the study protocol for any other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic endpoints * Tacrolimus whole blood concentrations * MPA plasma concentrations * Prednisolone plasma concentration Pharmacodynamic endpoints * Proliferation of T cells in PHA-stimulated whole blood * Cytokine production in PHA-stimulated whole blood * T cell activation marker expression in PHA-stimulated whole blood * Circulating regulatory T and B cell subsets Safety and tolerability endpoints * Treatment-emergent (serious) adverse events ((S)AEs). * Concomitant medication * Clinical laboratory tests | — |
Secondary
| Measure | Time frame |
|---|---|
| N.A. | — |
Countries
Netherlands
Outcome results
None listed