PEL-1235_REN-0176-I (Pelicon)

Technical University of Munich

Status: Completed

Conditions: Immunosuppression After Kidney Transplantation

Treatments: Other: tacrolimus Prograf; Other: tacrolimus Advagraf

Study type: Observational

Funder types: Other

Identifiers

NCT01904045

PEL-1235_REN-0176-I

Details and patient eligibility

About

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.

Enrollment: 51 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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