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This study will compare the efficacy and safety of 2 dosing regimens of oral CellCept administered as a component of standard immunosuppressive therapy in recipients of kidney transplants. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mycophenolate mofetil | Drug | 1 |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients achieving therapeutic window by Day 5\n |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy: Achieving therapeutic window at Day 3, maintaining therapeutic window at day of discharge, Months 1, 3, and 6\nSafety: Renal function, opportunistic infections, malignancies, and adverse events\n |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Edmonton | Alberta | T6G 2S2 | Canada | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20498245 | Derived | Gourishankar S, Houde I, Keown PA, Landsberg D, Cardella CJ, Barama AA, Dandavino R, Shoker A, Pirc L, Wrobel MM, Kiberd BA. The CLEAR study: a 5-day, 3-g loading dose of mycophenolate mofetil versus standard 2-g dosing in renal transplantation. Clin J Am Soc Nephrol. 2010 Jul;5(7):1282-9. doi: 10.2215/CJN.09091209. Epub 2010 May 24. |
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| ID | Term |
|---|---|
| D009173 | Mycophenolic Acid |
| ID | Term |
|---|---|
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Vancouver |
| British Columbia |
| V5Z 1M9 |
| Canada |
| Vancouver | British Columbia | V6Z 1Y6 | Canada |
| Halifax | Nova Scotia | B3H2Y9 | Canada |
| Toronto | Ontario | M5G 2C4 | Canada |
| Montreal | Quebec | H1T 2M4 | Canada |
| Montreal | Quebec | H2L 4M1 | Canada |
| Québec | Quebec | G1R 2J6 | Canada |
| Saskatoon | Saskatchewan | S7N 0W8 | Canada |
| D005227 |
| Fatty Acids |
| D008055 | Lipids |