PEL-1235_REN-0176-I (Pelicon)

N/ACompletedNCT01904045

Technical University of Munich51 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Immunosuppression After Kidney Transplantation

Interventions

tacrolimus AdvagrafOTHER

intake of Advagraf once daily for 3 months

tacrolimus PrografOTHER

intake of Prograf twice daily for 3 months

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Klinikum rechts der Isar, Department of Nephrology

Munich, Bavaria, Germany

Outcomes

Primary Outcomes

Intrapatient variability of tacrolimus through level

Time frame: pre-dose, 1 h post dose and 3 h post dose for 3 month

Data from ClinicalTrials.gov

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