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

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ClinicalTrials.gov Identifier: NCT02311010
Recruitment Status : Unknown
Verified December 2014 by Prof Martine De Meyer, Université Catholique de Louvain.
Recruitment status was:  Active, not recruiting
First Posted : December 8, 2014
Last Update Posted : December 8, 2014
Sponsor:
Information provided by (Responsible Party):
Prof Martine De Meyer, Université Catholique de Louvain

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Kidney Diseases Drug: Advagraf Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Influence of Recipient Cytochrome P450 3A5 Polymorphism on the Metabolism of Prolonged Release Tacrolimus Administered de Novo After Renal Transplantation
Study Start Date : January 2011
Actual Primary Completion Date : October 2014
Estimated Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Tacrolimus

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 Name: 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 Name: 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 Name: Tacrolimus prolonged release formulation




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Kidney graft function [ Time Frame: 1 year ]
    serum creatinine level (mg/dl) and GFR (ml/min)


Other Outcome Measures:
  1. Administration strategy [ Time Frame: first day ]
    starting tacrolimus daily dose (mg/kg/d) accorded to CYP 3A5 polymorphism of the recipient

  2. New onset of diabetes after transplantation (NODAT) [ Time Frame: 1 year ]
    fasting glycemia (mg/dl) HbA1C (%)



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Ages Eligible for Study:   15 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02311010


Locations
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Belgium
Cliniques universitaires Saint Luc Université Catholique de Louvain
Brussels, Belgium, 1200
Sponsors and Collaborators
Université Catholique de Louvain

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Prof Martine De Meyer, MD, Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT02311010    
Other Study ID Numbers: BE-02-RG-234
2011-004276-11 ( EudraCT Number )
First Posted: December 8, 2014    Key Record Dates
Last Update Posted: December 8, 2014
Last Verified: December 2014
Keywords provided by Prof Martine De Meyer, Université Catholique de Louvain:
transplant
immunosuppressive drug
Additional relevant MeSH terms:
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Kidney Diseases
Urologic Diseases
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action