Immunomonitoring of stable renal transplantation patients
- Conditions
- Immunosuppression
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 20
Male or female kidney transplantation patients, 18 to 45 years of age or >60 years of age
- 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
- 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;
- 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.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pharmacokinetic endpoints<br>– Tacrolimus whole blood concentrations<br>– MPA plasma concentrations<br>– Prednisolone plasma concentration<br><br>Pharmacodynamic endpoints<br>– Proliferation of T cells in stimulated whole blood<br>– Cytokine production in stimulated whole blood<br>– T cell activation marker expression in stimulated whole blood<br>– Circulating regulatory T and B cell subsets<br><br>Safety and tolerability endpoints<br>– Treatment-emergent (serious) adverse events ((S)AEs).<br>– Concomitant medication<br>– Clinical laboratory tests
- Secondary Outcome Measures
Name Time Method