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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-003184-29 | EudraCT Number |
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| Name | Class |
|---|---|
| Astellas Pharma Inc | INDUSTRY |
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The purpose of this study is to compare parallel-group effects between 4 months and 12 months post-transplantation 2 values of target residual concentrations of Advagraf on vascular parameters in de novo renal transplant patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A - tacrolimus half-dose | Experimental | Immunosuppressive strategy with 50 % reduction of Advagraf® daily dose at M4 (randomization) and unchanged MMF dose. Targeted tacrolimus trough level are to be higher than 3 ng/mL . If the dose is not in adequation with the dispensable units, the prescribed dose will be the closest higher dose. Drug: Tacrolimus targeted half-dose |
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| Group B - tacrolimus unchanged dose | Experimental | Immunosuppressive strategy will remain identical after randomization (M4): unchanged Advagraf® and MMF doses. Targeted tacrolimus trough level are to be between 7 and 12 ng/mL Drug: Tacrolimus targeted plain dose |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tacrolimus targeted half-dose | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| Aorta stiffness at one year post-tranplantation | Evaluate the aorta stiffness at 1 year post-renal transplantation and its evolution in patients who received a half reduction of their daily dose of Advagraf ® 4 months after transplantation compared with patients whose dose has not been divided. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure | Evaluate peripheral and central blood pressures, the impact of reflected pressure waves and coupling cardiocirculatory (on the functional plan) and evaluate endothelial activation, factors promoting the vascular fibrosis and oxidant stress level (on biological plan) at 1 year post-renal transplantation and their evolution in patients who received a hal reduction of their daily dose Advagraf ® to four months of the transplant when compared with patients whose dose was not divided. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Robinson JOANNIDES | Contact | Robinson.Joannides@chu-rouen.fr | ||
| Mélissa DELHOMMEAU | Contact | m.delhommeau@chu-tours.fr |
| Name | Affiliation | Role |
|---|---|---|
| Robinson JOANNIDES | University Hospital, Rouen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Amiens | Recruiting | Amiens | France |
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| Tacrolimus targeted plain dose |
| Drug |
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| 12 months |
| Endothelial activation at one year post-tranplantation | Evaluate peripheral and central blood pressures, the impact of reflected pressure waves and coupling cardiocirculatory (on the functional plan) and evaluate endothelial activation, factors promoting the vascular fibrosis and oxidant stress level (on biological plan) at 1 year post-renal transplantation and their evolution in patients who received a hal reduction of their daily dose Advagraf ® to four months of the transplant when compared with patients whose dose was not divided. | 12 months |
| CHU de Angers | Recruiting | Angers | France |
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| CHU de Caen | Recruiting | Caen | France |
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| CHU de Clermont-Ferrand | Recruiting | Clermont-Ferrand | 63003 | France |
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| HEGP | Recruiting | Paris | France |
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| Necker | Recruiting | Paris | France |
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| CHU de Rennes | Recruiting | Rennes | France |
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| CHU de Rouen | Recruiting | Rouen | France |
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| CHU de Strasbourg | Recruiting | Strasbourg | France |
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| CHU de Toulouse | Recruiting | Toulouse | France |
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| CHRU de Tours | Recruiting | Tours | France |
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