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OpenTrials
Completed

NCT Number: NCT01904045

PEL-1235_REN-0176-I (Pelicon)

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.

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Key information

Conditions

Immunosuppression After Kidney Transplantation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Klinikum rechts der Isar, Department of Nephrology

Munich, Bavaria, 81675, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

tacrolimus Advagraf

Other

intake of Advagraf once daily for 3 months

tacrolimus Prograf

Other

intake of Prograf twice daily for 3 months

Primary outcomes

  1. Intrapatient variability of tacrolimus through level

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

Sponsors and collaborators

Lead sponsor

Technical University of Munich

Other

Registry information

Official study title

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

Acronym: Pelicon

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Jul 22, 2013
Registry last updated
Sep 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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