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

U

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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