PEL-1235_REN-0176-I (Pelicon) (Pelicon)

September 11, 2018 updated by: Technical University of Munich

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

51

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bavaria
      • Munic, Bavaria, Germany, 81675
        • Klinikum rechts der Isar, Department of Nephrology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Outpatient clinic

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Intrapatient variability of tacrolimus through level
Time Frame: pre-dose, 1 h post dose and 3 h post dose for 3 month
pre-dose, 1 h post dose and 3 h post dose for 3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Technical University of Munich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

January 1, 2018

Study Completion (Actual)

August 1, 2018

Study Registration Dates

First Submitted

July 2, 2013

First Submitted That Met QC Criteria

July 19, 2013

First Posted (Estimate)

July 22, 2013

Study Record Updates

Last Update Posted (Actual)

September 13, 2018

Last Update Submitted That Met QC Criteria

September 11, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PEL-1235_REN-0176-I

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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