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Prospective, multicenter, randomized and open label study evaluating the benefit on renal function at 12 months post-transplantation, with an immunosuppression without calcineurin inhibitor at 3 months and combining mycophenolate sodium-Everolimus versus an immunosuppression combining Everolimus-Tacrolimus, in de novo renal transplant patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Everolimus-Tacrolimus | Active Comparator |
|
|
| Everolimus-Mycophenolate sodium | Experimental |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Everolimus | Drug | Active Comparator |
|
| Measure | Description | Time Frame |
|---|---|---|
| Renal function as measured by estimated glomerular filtration rate GFR | GFR unit : mL / min / 1.73 m2 | One year after inclusion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Antoine THIERRY, MD | Poitiers University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amiens University Hospital | Amiens | 80000 | France | |||
| Angers University Hospital |
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| Tacrolimus | Drug | Active Comparator |
|
|
| Mycophenolate sodium | Drug | Experimental Arm |
|
|
| Angers |
| 49100 |
| France |
| Brest University Hospital | Brest | 29200 | France |
| Caen University Hospital | Caen | 14033 | France |
| Clermont Ferrand University Hospital | Clermont-Ferrand | 63000 | France |
| Limoges University Hospital | Limoges | 87000 | France |
| Georges Pompidou European Hospital | Paris | 75015 | France |
| Necker Hospital | Paris | 75015 | France |
| Poitiers University Hospital | Poitiers | 86000 | France |
| Reims University Hospital | Reims | 51000 | France |
| Rennes University Hospital | Rennes | 35000 | France |
| Rouen University Hospital | Rouen | 76000 | France |
| Strasbourg University Hospital | Strasbourg | 67000 | France |
| Tours University Hospital | Tours | 37000 | France |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000068338 | Everolimus |
| D016559 | Tacrolimus |
| D009173 | Mycophenolic Acid |
| ID | Term |
|---|---|
| D020123 | Sirolimus |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
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