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
Sponsored by
About this trial
This is an interventional treatment trial for Kidney Diseases focused on measuring transplant, immunosuppressive drug
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
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
Active Comparator
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
No
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
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