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

Kidney Diseases Clinical Trial

— CYRANO  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02311010
• Other study ID #: BE-02-RG-234
• Secondary ID: 2011-004276-11
• Status: Active, not recruiting
• Phase: Phase 4
• First received: August 21, 2014
• Last updated: December 4, 2014
• Start date: January 2011
• Est. completion date: January 2015

Study information

• Verified date: December 2014
• Source: Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: January 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Diseases

Intervention

Drug:
• Advagraf
daily dose adapted according to Cyp 3A5 polymorphism

Locations

Country	Name	City	State
Belgium	Cliniques universitaires Saint Luc Université Catholique de Louvain	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Administration strategy	starting tacrolimus daily dose (mg/kg/d) accorded to CYP 3A5 polymorphism of the recipient	first day	No
Other	New onset of diabetes after transplantation (NODAT)	fasting glycemia (mg/dl) HbA1C (%)	1 year	No
Primary	Pharmacokinetics of tacrolimus	tacrolimus level (ng/ml) at C0 every 3 days during 2 weeks and thereafter every month during 1 year	1 year	No
Secondary	Kidney graft function	serum creatinine level (mg/dl) and GFR (ml/min)	1 year	Yes