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| Name | Class |
|---|---|
| Astellas Pharma Europe B.V. | INDUSTRY |
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Primary objective of this study is to compare the renal function as well as the incidence of renal dysfunction, the incidence of death, graft loss and acute rejection. Secondary Objective is to compare the efficacy and safety profiles of the two regimens in elderly renal transplanted patients.
The use of tacrolimus-based primary immunosuppression in elderly renal transplant recipients is efficacious and safe, particularly in combination with MMF, and seems to be associated with lower mortality and graft loss rates than classic cyclosporin protocols. Nevertheless, the efficacy and safety of tacrolimus in monotherapy, double or triple therapy with MMF, as well as the induction therapy with the new anti-IL2 receptor antibodies have not been adequately used in controlled trials in the elderly renal transplant patient. There is only scarce information on age-associated immune responsiveness and only a few aged-adapted immunosuppressive regimens have been described.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator |
| |
| 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tacrolimus | Drug | Immunosuppression |
|
| Measure | Description | Time Frame |
|---|---|---|
| Renal function measured by creatinine clearance | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Acute rejection | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Physician | Astellas Pharma Europe B.V. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brussels | 1200 | Belgium | ||||
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| Label | URL |
|---|---|
| Link to FDA Website | View source |
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| Leuven |
| 3000 |
| Belgium |
| Bordeaux | 33076 | France |
| Clermont-Ferrand | 63003 | France |
| Créteil | 94010 | France |
| Le Kremlin-Bicêtre | 94275 | France |
| Montpellier | 34295 | France |
| Nice | 06002 | France |
| Suresnes | 92151 | France |
| Toulouse | 31059 | France |
| Tours | 37044 | France |
| Vandœuvre-lès-Nancy | 54511 | France |
| Berlin | 10117 | Germany |
| Cologne | 50931 | Germany |
| Cologne | 51109 | Germany |
| Essen | 45122 | Germany |
| Freiberg | 79106 | Germany |
| Halle | 06120 | Germany |
| Hanover | 30625 | Germany |
| Jena | 07747 | Germany |
| Leipzig | 04103 | Germany |
| Lübeck | 23562 | Germany |
| München | 81675 | Germany |
| Münster | 48149 | Germany |
| Rostock | 18057 | Germany |
| Utrecht | 3508 | Netherlands |
| Madrid | 28007 | Spain |
| Madrid | 28041 | Spain |
| Santander | 39008 | Spain |
| Zurich | 8091 | Switzerland |
| Belfast | BT9 7AB | United Kingdom |
| Cambridge | CB2 2QQ | United Kingdom |
| Nottingham | NG5 1PB | United Kingdom |
| ID | Term |
|---|---|
| D016559 | Tacrolimus |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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