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

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02311010

Acronym

CYRANO

Enrollment

150

Registered

2014-12-08

Start date

2011-01-31

Completion date

2015-01-31

Last updated

2014-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Diseases

Keywords

transplant, immunosuppressive drug

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.

Interventions

DRUGAdvagraf

daily dose adapted according to Cyp 3A5 polymorphism

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

15 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Other

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

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026