A Multicentre, Prospective, Non-Interventional Study to Assess the Intra-patient Variability of Tacrolimus Once and Twice Daily After Kidney Transplantation

Technical University of Munich1 site in 1 country51 target enrollmentMay 2013

ConditionsImmunosuppression After Kidney Transplantation

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Immunosuppression After Kidney Transplantation
Sponsor: Technical University of Munich
Enrollment: 51
Locations: 1
Primary Endpoint: Intrapatient variability of tacrolimus through level
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 2013

End Date

August 2018

Last Updated

7 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Technical University of Munich

Responsible Party

Sponsor

Eligibility Criteria

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