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To compare the efficacy and safety of two regimens containing tacrolimus and minimal steroids together with either monoclonal anti-IL2R antibodies (daclizumab) or mycophenolate mofetil.
This prospective randomised trial which combines MMF with tacrolimus and so avoids steroids in immunosuppressive maintenance could demonstrate alternatives to current immunosuppressive regimens. There is evidence that reduced steroid usage could further decrease the onset of diabetes mellitus, hypertension and viral infections combined with high efficacy for patients and graft survival. Since the use of MMF in liver transplantation is becoming an alternative in the rescue setting this could contribute to a steroid-free immunosuppressive approach.
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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 |
|---|---|---|
| Incidence of and time to first biopsy proven acute rejection which requires treatment within 3 months following transplantation | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Acute rejection. Incidence of and time to first acute rejection. Incidence of and time to first corticosteroid-resistant acute rejection. | 3 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 |
|---|---|---|---|---|---|---|
| Ghent | 9000 | Belgium | ||||
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| Label | URL |
|---|---|
| Link to FDA website | View source |
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| Leuven |
| 3000 |
| Belgium |
| Liège | Belgium |
| Copenhagen | Denmark |
| Helsinki | 00130 | Finland |
| Bonn | 53105 | Germany |
| Erlangen | 91054 | Germany |
| Essen | 45122 | Germany |
| Hamburg | 20251 | Germany |
| Hanover | 30625 | Germany |
| Kiel | 24105 | Germany |
| Mainz | 55131 | Germany |
| Budapest | 1082 | Hungary |
| Bari | 70124 | Italy |
| Bergamo | 24128 | Italy |
| Milan | 20122 | Italy |
| Milan | 20162 | Italy |
| Naples | 80131 | Italy |
| Padova | 35128 | Italy |
| Palermo | 90134 | Italy |
| Udine | 33100 | Italy |
| Szczecin | 71-455 | Poland |
| Wroclaw | 50-326 | Poland |
| A Coruña | 15006 | Spain |
| Barcelona | 08035 | Spain |
| Córdoba | 14004 | Spain |
| Granada | 18012 | Spain |
| Madrid | 28007 | Spain |
| Madrid | 28034 | Spain |
| Madrid | 28035 | Spain |
| Murcia | 30120 | Spain |
| Pamplona | 31008 | Spain |
| Santiago | 15706 | Spain |
| Seville | 41013 | Spain |
| Valencia | 46009 | Spain |
| Gothenburg | 41345 | Sweden |
| Uppsala | 75105 | Sweden |
| Bern | 3010 | Switzerland |
| Zurich | 8091 | Switzerland |
| Leeds | United Kingdom |
| Newcastle | United Kingdom |
| ID | Term |
|---|---|
| D016559 | Tacrolimus |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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