Back to results

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

Primary Purpose

Kidney Diseases

Status

Unknown status

Phase

Phase 4

Locations

Belgium

Study Type

Interventional

Intervention

Advagraf

About this trial

This is an interventional treatment trial for Kidney Diseases focused on measuring transplant, immunosuppressive drug

Eligibility Criteria

15 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Cliniques universitaires Saint Luc Université Catholique de Louvain

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Active Comparator

Arm Label

CYP 3 A 5 *3/*3 control group

CYP 3 A 5 *3/*3

CYP 3 A 5 *1/*3

CYP 3 A 5 *1/*1

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Pharmacokinetics of tacrolimus

tacrolimus level (ng/ml) at C0 every 3 days during 2 weeks and thereafter every month during 1 year

Secondary Outcome Measures

Kidney graft function

serum creatinine level (mg/dl) and GFR (ml/min)

Full Information

NCT ID

NCT02311010

First Posted

August 21, 2014

Last Updated

December 4, 2014

Sponsor

Université Catholique de Louvain

1. Study Identification

Unique Protocol Identification Number

NCT02311010

Brief Title

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

Acronym

CYRANO

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2014

Overall Recruitment Status

Unknown status

Study Start Date

January 2011 (undefined)

Primary Completion Date

October 2014 (Actual)

Study Completion Date

January 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Université Catholique de Louvain

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Kidney Diseases

Keywords

transplant, immunosuppressive drug

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

CYP 3 A 5 *3/*3 control group

Arm Type

No Intervention

Arm Description

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

Arm Title

CYP 3 A 5 *3/*3

Arm Type

Active Comparator

Arm Description

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

Arm Title

CYP 3 A 5 *1/*3

Arm Type

Active Comparator

Arm Description

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

Arm Title

CYP 3 A 5 *1/*1

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Advagraf

Other Intervention Name(s)

Tacrolimus prolonged release formulation

Intervention Description

daily dose adapted according to Cyp 3A5 polymorphism

Primary Outcome Measure Information:

Title

Pharmacokinetics of tacrolimus

Description

tacrolimus level (ng/ml) at C0 every 3 days during 2 weeks and thereafter every month during 1 year

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Kidney graft function

Description

serum creatinine level (mg/dl) and GFR (ml/min)

Time Frame

1 year

Other Pre-specified Outcome Measures:

Title

Administration strategy

Description

starting tacrolimus daily dose (mg/kg/d) accorded to CYP 3A5 polymorphism of the recipient

Time Frame

first day

Title

New onset of diabetes after transplantation (NODAT)

Description

fasting glycemia (mg/dl) HbA1C (%)

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

Cliniques universitaires Saint Luc Université Catholique de Louvain

City

Brussels

ZIP/Postal Code

1200

Country

Belgium

12. IPD Sharing Statement

Citations:

PubMed Identifier

27266721

Citation

De Meyer M, Haufroid V, Kanaan N, Darius T, Buemi A, De Pauw L, Eddour DC, Wallemacq P, Mourad M. Pharmacogenetic-based strategy using de novo tacrolimus once daily after kidney transplantation: prospective pilot study. Pharmacogenomics. 2016 Jun;17(9):1019-27. doi: 10.2217/pgs-2016-0005. Epub 2016 Jun 8.

Results Reference

derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs