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The primary objective of the study is to evaluate that 3 immunosuppressant regimens will have comparable kidney function results in kidney transplant patients.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Myfortic | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Calculated glomerular filtration rate after 12 months treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of death, graft loss, biopsy-proven acute rejection after 3 and 12 months. | ||
| Patient and graft survival after 12 months. | ||
| Incidence of AEs and SAEs after 3 and 12 months. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis | Novartis | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF Kidney Transplant Service | San Francisco | California | 94143-0780 | United States | ||
| Livelink, Inc. |
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| Blood pressure, lipids and glucose profiles after 3 and 12 months. |
| Percentage of patients free of steroids at 12 months |
| Tampa |
| Florida |
| 33606 |
| United States |
| Loyola Medical Center | Maywood | Illinois | 60153 | United States |
| Indiana U. Medical Center | Indianapolis | Indiana | 46202 | United States |
| University of Michigan Health System | Ann Arbor | Michigan | 48109 | United States |
| University Hospitals of Cleveland, Division of Nephrology | Cleveland | Ohio | 44106 | United States |
| Ohio State University Medical Center | Columbus | Ohio | 43210 | United States |
| Legacy Research & Technology Ctr. | Portland | Oregon | 97232 | United States |
| U. of Wisconsin Hospital Clinics | Madison | Wisconsin | 53792-7375 | United States |
| Crai Norte | San Martín | Buenos Aires | 1650 | Argentina |
| Hospital Cordoba | Córdoba | Córdoba Province | 5000 | Argentina |
| Unidad de Transplante Velez Sarsfield | Córdoba | Córdoba Province | X5016JDA | Argentina |
| Royal Prince Alfred Hospital | Camperdown | New South Wales | 2050 | Australia |
| Princess Alexandra Hospital | Woolloongabba | Queensland | 4102 | Australia |
| The Queen Elizabeth Hospital | Woodville | South Australia | 5011 | Australia |
| Monash Medical Centre | Clayton | Victoria | 3168 | Australia |
| Royal Melbourne Hospital | Parkville | Victoria | 3052 | Australia |
| Hospital das Clinicas - UNICAMP | Campinas | São Paulo | 13083-970 | Brazil |
| Hipertensao Hospital do Rim e Hipertensao | São Paulo | São Paulo | 04023 900 | Brazil |
| Foothills Medical Center | Calgary | Alberta | T2N 2T9 | Canada |
| University of Alberta Hospital | Edmonton | Alberta | T6G 2B7 | Canada |
| Queen II Health and Science Center | Halifax | Nova Scotia | B3H 2Y6 | Canada |
| St. Michael's Hospital | Toronto | Ontario | M5C 2T2 | Canada |
| University Health Network, The Toronto Hospital | Toronto | Ontario | M5G 2C4 | Canada |
| McGill University Health Centre | Montreal | Quebec | H3A 1A1 | Canada |
| Royal University Hospital | Saskatoon | Saskatchewan | S7N 0W8 | Canada |
| Staedt. Krankenhaus Koeln-Merheim | Cologne | 51109 | Germany |
| Klinikum der Johann Wolfgang Geothe-Universitaet | Frankfurt am Main | 60596 | Germany |
| Ospedale Consorziale e policlinico-Universita degli Studi | Bari | BA | 70124 | Italy |
| Hospital Kuala Lumpur | Kuala Lumpur | 50586 | Malaysia |
| Auckland Hospital | Auckland | Grafton | New Zealand |
| Singapore General Hospital | Singapore | 169608 | Singapore |
| Hospital Clinico San Carlos | Madrid | Madrid | 28040 | Spain |
| Hospital Central de Asturias | Oviedo | Oviedo | 33006 | Spain |
| Hospital de Bellvitge | L'Hospitalet de Llobregat | 08907 | Spain |
| Chang-Gung Memorial Hospital-Linko | Taoyuan | Lin-Ko | 333 | Taiwan |
| Taipei Veterans General Hospital | Taipei | ROC | Taiwan |
| National Taiwan University Hospital | Taipei | 100 | Taiwan |
| Queen Elizabeth Medical Centre | Edgbaston | Birmingham | B15 2TH | United Kingdom |
| University Hospital of Wales | Heathpark | Cardiff | CF14 4XW | United Kingdom |
| Walsgrave Hospital NHS Trust | Walsgrave on Sowe | Coventry | CV2 2DX | United Kingdom |
| Freeman Hospital | High Heaton | Newcastle Upon Tyne | NE7 7DN | United Kingdom |
| Guy's Hospital | London | SE1 9RT | United Kingdom |
| Nottingham City Hospital | Nottingham | NG5 1BP | United Kingdom |
| ID | Term |
|---|---|
| D009173 | Mycophenolic Acid |
| ID | Term |
|---|---|
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D005227 | Fatty Acids |
| D008055 | Lipids |
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