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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-004276-11 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CYP 3 A 5 *3/*3 control group | No Intervention | CYP 3 A 5 *3/*3 control group will receive 0,20 mg/kg of Advagraf® | |
| CYP 3 A 5 *3/*3 | Active Comparator | CYP 3 A 5 *3/*3 will receive 0,25 mg/kg of Advagraf® |
|
| CYP 3 A 5 *1/*3 | Active Comparator | CYP 3 A 5 *1/*3 will receive 0,30 mg/kg of Advagraf® |
|
| CYP 3 A 5 *1/*1 | Active Comparator | CYP 3 A 5 *1/*1 will receive 0,35 mg/kg of Advagraf® |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Advagraf | Drug | daily dose adapted according to Cyp 3A5 polymorphism |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of tacrolimus | tacrolimus level (ng/ml) at C0 every 3 days during 2 weeks and thereafter every month during 1 year | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Kidney graft function | serum creatinine level (mg/dl) and GFR (ml/min) | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Administration strategy | starting tacrolimus daily dose (mg/kg/d) accorded to CYP 3A5 polymorphism of the recipient | first day |
| New onset of diabetes after transplantation (NODAT) | fasting glycemia (mg/dl) HbA1C (%) |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cliniques universitaires Saint Luc Université Catholique de Louvain | Brussels | 1200 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27266721 | Derived | 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. |
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| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| 1 year |
| D052801 | Male Urogenital Diseases |