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

Université Catholique de Louvain

Status and phase: Unknown; Phase 4

Conditions: Kidney Diseases

Treatments: Drug: Advagraf

Study type: Interventional

Funder types: Other

Identifiers

NCT02311010

BE-02-RG-234

2011-004276-11 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 15 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

150 participants in 4 patient groups

CYP 3 A 5 *3/*3 control group

No Intervention group

Description:

CYP 3 A 5 \*3/\*3 control group will receive 0,20 mg/kg of Advagraf®

CYP 3 A 5 *3/*3

Active Comparator group

Description:

CYP 3 A 5 \*3/\*3 will receive 0,25 mg/kg of Advagraf®

Treatment:

Drug: Advagraf

CYP 3 A 5 *1/*3

Active Comparator group

Description:

CYP 3 A 5 \*1/\*3 will receive 0,30 mg/kg of Advagraf®

Treatment:

Drug: Advagraf

CYP 3 A 5 *1/*1

Active Comparator group

Description:

CYP 3 A 5 \*1/\*1 will receive 0,35 mg/kg of Advagraf®

Treatment:

Drug: Advagraf