PEL-1235_REN-0176-I (Pelicon)
Completed
- Conditions
- Immunosuppression After Kidney Transplantation
- Registration Number
- NCT01904045
- Lead Sponsor
- Technical University of Munich
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 51
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Intrapatient variability of tacrolimus through level pre-dose, 1 h post dose and 3 h post dose for 3 month
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Klinikum rechts der Isar, Department of Nephrology
🇩🇪Munic, Bavaria, Germany