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This study will compare kidney function in kidney transplant patients following treatment with various combinations of Zenapax, CellCept, corticosteroids, and Neoral (Cyclosporine). The anticipated time on study treatment is 6-12 months, and the target sample size is 500+ individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
| |
| 3 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Corticosteroids | Drug | As prescribed |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Renal function (as measured by GFR) | 12 months post-transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Patient and graft survival \n | 12 months post-transplant | |
| Proportion of patients with biopsy-proven rejection; treatment failure. | 6 and 12 months post-transplant | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | 35294 | United States | |||
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| Neoral |
| Drug |
Low dose (target trough level 50-100ng/mL) |
|
| Neoral | Drug | Standard dose (target trough level 150-300ng/mL) |
|
| Zenapax | Drug | 2mg/kg iv first dose, then 1mg/kg every 2 weeks |
|
| mycophenolate mofetil [CellCept] | Drug | 1g po bid |
|
| AEs, OIs, malignancies, deaths |
| Throughout study |
| San Francisco |
| California |
| 94143 |
| United States |
| Gainesville | Florida | 32610 | United States |
| Atlanta | Georgia | 30322 | United States |
| Livingston | New Jersey | 07039 | United States |
| Philadelphia | Pennsylvania | 19102-1192 | United States |
| Charleston | South Carolina | 29425-0777 | United States |
| Falls Church | Virginia | 22042-3300 | United States |
| Adelaide | 5011 | Australia |
| Sydney | 2050 | Australia |
| Brussels | 1070 | Belgium |
| Leuven | 3000 | Belgium |
| Calgary | Alberta | T2N 2T9 | Canada |
| Edmonton | Alberta | T6G 2R8 | Canada |
| Vancouver | British Columbia | V6Z 1Y6 | Canada |
| Saskatoon | Saskatchewan | S7N 0W8 | Canada |
| Vandœuvre-lès-Nancy | 54511 | France |
| Berlin | 13353 | Germany |
| Hanover | 30625 | Germany |
| Münster | 48149 | Germany |
| Mexico City | 06720 | Mexico |
| Monterrey | 06720 | Mexico |
| Oslo | 0027 | Norway |
| Warsaw | 02-006 | Poland |
| Wroclaw | 50-417 | Poland |
| Barcelona | 08036 | Spain |
| Barcelona | 08907 | Spain |
| Córdoba | 14004 | Spain |
| Málaga | 29010 | Spain |
| Santander | 39008 | Spain |
| Valencia | 46009 | Spain |
| Gothenburg | 41345 | Sweden |
| Malmö | 20502 | Sweden |
| Birmingham | B15 2TH | United Kingdom |
| Glasgow | G11 6NT | United Kingdom |
| Leicester | LE5 4PW | United Kingdom |
| ID | Term |
|---|---|
| D000305 | Adrenal Cortex Hormones |
| D016572 | Cyclosporine |
| D000077561 | Daclizumab |
| D009173 | Mycophenolic Acid |
| ID | Term |
|---|---|
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D005227 | Fatty Acids |
| D008055 | Lipids |
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