Status:
COMPLETED
PEL-1235_REN-0176-I (Pelicon)
Lead Sponsor:
Technical University of Munich
Conditions:
Immunosuppression After Kidney Transplantation
Eligibility:
All Genders
18+ years
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 a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2018
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT01904045
Start Date
May 1 2013
End Date
August 1 2018
Last Update
September 13 2018
Active Locations (1)
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1
Klinikum rechts der Isar, Department of Nephrology
Munich, Bavaria, Germany, 81675