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| Name | Class |
|---|---|
| Astellas Pharma Europe B.V. | INDUSTRY |
A dose finding study to evaluate the safety and effectiveness of FK778 in kidney transplant patients
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FK778 | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of biopsy-proven acute rejection over the first 24 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy:Incidence of and time to first biopsy-proven acute rejection over the first 24 weeks and after 1 year | ||
| Incidence of and time to first corticosteroid-resistant acute rejections over the first 24 weeks and after 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| H. H. Neumayer | Universitätsklinik Charité | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Innsbruck | 6020 | Austria | ||||
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| Incidence of and time to first acute rejection by signs and symptoms over the first 24 weeks and after 1 year |
| Severity of biopsy-proven acute rejections (Banff criteria) over the first 24 weeks and after 1 year |
| Frequency of treatment failure (as defined below) over the first 24 weeks and after 1 year |
| Renal function as measured by serum creatinine concentrations and calculated creatinine clearance (Cockcroft formula) over the first 24 weeks and after 1 year |
| Chronic allograft dysfunction assessed by chronic allograft damage index (CADI) after 24 weeks of transplantation. |
| Safety first 24 weeks: Patient survival |
| Graft survival |
| Incidence of adverse events |
| Routine safety laboratory parameters |
| Haemoglobin values at weeks two to six |
| Leukocytes at weeks two to six |
| Thrombocytes at weeks two to six |
| Bilirubin at weeks two to six |
| Incidence of CMV viraemia |
| Incidence of Diarrhoea, Gastroenteritis and Gastritis |
| Safety after 1 year:Incidence of adverse events |
| Patient and graft survival |
| Brussels |
| 1070 |
| Belgium |
| Brussels | 1200 | Belgium |
| Leuven | 3000 | Belgium |
| Prague | 14021 | Czechia |
| Brest | 29 200 | France |
| Créteil | 94010 | France |
| Grenoble | France |
| Le Kremlin-Bicêtre | 94275 | France |
| Montpellier | 34295 | France |
| Rennes | 35003 | France |
| Saint-Etienne | 42055 | France |
| Toulouse | 31 403 | France |
| Berlin | 10117 | Germany |
| Berlin | 13353 | Germany |
| Essen | 45122 | Germany |
| Frankfurt | 60590 | Germany |
| Halle | 06112 | Germany |
| München | 81675 | Germany |
| Regensburg | 93053 | Germany |
| Padova | 35128 | Italy |
| Roma | 00168 | Italy |
| Torino | 10126 | Italy |
| Maastricht | 6202 | Netherlands |
| Bydgoszcz | 85-094 | Poland |
| Szczecin | 70-111 | Poland |
| Barcelona | 08025 | Spain |
| Barcelona | 08036 | Spain |
| Barcelona | 08907 | Spain |
| Córdoba | 14004 | Spain |
| Madrid | 28034 | Spain |
| Madrid | 28041 | Spain |
| Santander | 39008 | Spain |
| Valencia | 46009 | Spain |
| Uppsala | 75185 | Sweden |
| Zurich | 8091 | Switzerland |
| Manchester | M13 9WL | United Kingdom |
| ID | Term |
|---|---|
| C115284 | 2-cyano-3-hydroxy-N-(4-(trifluoromethyl)phenyl)-2-hepten-6-ynamide |
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