Immunosuppression After Kidney Transplantation
Conditions
Brief summary
Aim of this study is to investigate whether in patients following kidney transplantation (\>6 months after transplantation), the intra-patient variability of levels of tacrolimus is comparable after administration of tacrolimus twice daily (Prograf) to tacrolimus once daily (Advagraf), with each regimen for 3 months.
Interventions
OTHERtacrolimus Advagraf
intake of Advagraf once daily for 3 months
OTHERtacrolimus Prograf
intake of Prograf twice daily for 3 months
Sponsors
Technical University of Munich
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* signed written informed consent * male or female patient ≥ 18years of age * Patient has received a kidney transplantation at least 6 months prior to inclusion into the study * No acute rejection episodes for at least 3 months * PRG through level and dosing stable for at least 1 month * Patient is capable of understanding the purpose and risks of the study, has been fully informed and has given written informed consent to participate in the study
Exclusion criteria
* Acute rejection episodes within the last 3 months prior to study entry * Unstable PRG trough level or dose change in the month before study entry * History of noncompliance to medical regimens * Patients unwilling to or unable to comply with the protocol * Treatment with another investigational product during this study or during the last 30 days prior to study start
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intrapatient variability of tacrolimus through level | pre-dose, 1 h post dose and 3 h post dose for 3 month |
Countries
Germany
Outcome results
None listed