Immunomonitoring of stable renal transplantation patients receiving triple immunosuppressive therapy

Completed

Conditions: Prophylaxis of the rejection of an allogeneic organ
Immunosuppression

Registration Number: NL-OMON55264

Lead Sponsor: Centre for Human Drug Research

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 20

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

- 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.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Pharmacokinetic endpoints<br /><br>* Tacrolimus whole blood concentrations<br /><br>* MPA plasma concentrations<br /><br>* Prednisolone plasma concentration<br /><br><br /><br>Pharmacodynamic endpoints<br /><br>* Proliferation of T cells in PHA-stimulated whole blood<br /><br>* Cytokine production in PHA-stimulated whole blood<br /><br>* T cell activation marker expression in PHA-stimulated whole blood<br /><br>* Circulating regulatory T and B cell subsets<br /><br><br /><br>Safety and tolerability endpoints<br /><br>* Treatment-emergent (serious) adverse events ((S)AEs).<br /><br>* Concomitant medication<br /><br>* Clinical laboratory tests</p><br>

Secondary Outcome Measures