Practical Use of Advagraf de Novo After Kidney Transplantation According to Recipient Genetic Polymorphism (CYRANO)

December 4, 2014 updated by: Prof Martine De Meyer, Université Catholique de Louvain

Influence of Recipient Cytochrome P450 3A5 Polymorphism on the Metabolism of Prolonged Release Tacrolimus Administered de Novo After Renal Transplantation

To optimize the Advagraf (tacrolimus once a day) initial daily dose used in de novo after kidney transplantation in combination with MMF (or MPA) and corticosteroids (CS) regarding of the genetic Cyp 450 3A5 polymorphism of the recipient.

The study of the tacrolimus through level (ng/ml) determines if the therapeutic level is reached.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Phase 4

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

  • Belgium
      • Brussels, Belgium, 1200
        • Cliniques universitaires Saint Luc Université Catholique de Louvain

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

15 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • First or second Kidney Transplantation from deceased or living donor

Exclusion Criteria:

  • Donor age < 5 years.
  • Patients who require plasma exchange because of high immunological risk

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: CYP 3 A 5 *3/*3 control group
CYP 3 A 5 *3/*3 control group will receive 0,20 mg/kg of Advagraf®
Active Comparator: CYP 3 A 5 *3/*3
CYP 3 A 5 *3/*3 will receive 0,25 mg/kg of Advagraf®
Drug: Advagraf
daily dose adapted according to Cyp 3A5 polymorphism
Other Names:
  • Tacrolimus prolonged release formulation
Active Comparator: CYP 3 A 5 *1/*3
CYP 3 A 5 *1/*3 will receive 0,30 mg/kg of Advagraf®
Drug: Advagraf
daily dose adapted according to Cyp 3A5 polymorphism
Other Names:
  • Tacrolimus prolonged release formulation
Active Comparator: CYP 3 A 5 *1/*1
CYP 3 A 5 *1/*1 will receive 0,35 mg/kg of Advagraf®
Drug: Advagraf
daily dose adapted according to Cyp 3A5 polymorphism
Other Names:
  • Tacrolimus prolonged release formulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetics of tacrolimus
Time Frame: 1 year
tacrolimus level (ng/ml) at C0 every 3 days during 2 weeks and thereafter every month during 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Kidney graft function
Time Frame: 1 year
serum creatinine level (mg/dl) and GFR (ml/min)
1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Administration strategy
Time Frame: first day
starting tacrolimus daily dose (mg/kg/d) accorded to CYP 3A5 polymorphism of the recipient
first day
New onset of diabetes after transplantation (NODAT)
Time Frame: 1 year
fasting glycemia (mg/dl) HbA1C (%)
1 year

Collaborators and Investigators

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

Sponsor

Université Catholique de Louvain

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2011

Primary Completion (Actual)

October 1, 2014

Study Completion (Anticipated)

January 1, 2015

Study Registration Dates

First Submitted

August 21, 2014

First Submitted That Met QC Criteria

December 4, 2014

First Posted (Estimate)

December 8, 2014

Study Record Updates

Last Update Posted (Estimate)

December 8, 2014

Last Update Submitted That Met QC Criteria

December 4, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BE-02-RG-234
  • 2011-004276-11 (EudraCT Number)

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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