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A study comparing the early withdrawal of steroids to long-term maintenance steroid therapy in Kidney Transplant Patients receiving Prograf and Cellcept
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | early steroid cessation |
|
| 2 | Experimental | long-term maintenance steroids |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tacrolimus | Drug | Oral |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of death, graft loss, or severe acute rejection | 6 months, 12 months, yearly up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of patient and graf survival | 6 months, 12 months, yearly up to 5 years | |
| Incidence and severity of acute rejection | 6 months, 12 months, yearly up to 5 years | |
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Exclusion:
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| Name | Affiliation | Role |
|---|---|---|
| central contact | Astellas Pharma US, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Little Rock | Arkansas | 72205 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15848538 | Background | Woodle ES; Fujisawa Corticosteroid Withdrawal Study Group. A prospective, randomized, multicenter, double-blind study of early corticosteroid cessation versus long-term maintenance of corticosteroid therapy with tacrolimus and mycophenolate mofetil in primary renal transplant recipients: one year report. Transplant Proc. 2005 Mar;37(2):804-8. doi: 10.1016/j.transproceed.2004.12.083. | |
| 18936569 |
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| CellCept | Drug | IV or Oral |
|
|
| steroids (methylprednisone or prednisone) | Drug | IV or Oral |
|
|
| Need for antilymphocyte treatment |
| 6 months, 12 months, yearly up to 5 years |
| Graft function | 6 month, 12 months, yearly up to 5 years |
| Framingham Coronary Heart Disease Risk Factors | 6 months, 12 months, yearly up to 5 years |
| Loma Linda |
| California |
| 92354 |
| United States |
| Los Angeles | California | 90057 | United States |
| Denver | Colorado | 80262 | United States |
| Chicago | Illinois | 60637 | United States |
| Lexington | Kentucky | 40536 | United States |
| New Orleans | Louisiana | 70121 | United States |
| Baltimore | Maryland | 21201 | United States |
| Boston | Massachusetts | 02111 | United States |
| Detroit | Michigan | 48202 | United States |
| Minneapolis | Minnesota | 55455 | United States |
| Rochester | Minnesota | 55905 | United States |
| Omaha | Nebraska | 68198 | United States |
| New Brunswick | New Jersey | 08903 | United States |
| Buffalo | New York | 14203 | United States |
| New York | New York | 10021 | United States |
| New York | New York | 10029 | United States |
| Cincinnati | Ohio | 45267 | United States |
| Cleveland | Ohio | 44106 | United States |
| Philadelphia | Pennsylvania | 19107 | United States |
| Providence | Rhode Island | 02903 | United States |
| Memphis | Tennessee | 38163 | United States |
| Nashville | Tennessee | 37232 | United States |
| Galveston | Texas | 77555 | United States |
| San Antonio | Texas | 78229 | United States |
| Salt Lake City | Utah | 84103 | United States |
| Salt Lake City | Utah | 84132 | United States |
| Madison | Wisconsin | 53792 | United States |
| Milwaukee | Wisconsin | 53226 | United States |
| Background |
| Woodle ES, First MR, Pirsch J, Shihab F, Gaber AO, Van Veldhuisen P; Astellas Corticosteroid Withdrawal Study Group. A prospective, randomized, double-blind, placebo-controlled multicenter trial comparing early (7 day) corticosteroid cessation versus long-term, low-dose corticosteroid therapy. Ann Surg. 2008 Oct;248(4):564-77. doi: 10.1097/SLA.0b013e318187d1da. |
| 23423269 | Derived | Gaber AO, Moore LW, Alloway RR, Woodle ES, Pirsch J, Shihab F, Henning A, Fitzsimmons W, Holman J, Reisfield R, First MR; Astellas Corticosteroid Withdrawal Study Group. Acute rejection characteristics from a prospective, randomized, double-blind, placebo-controlled multicenter trial of early corticosteroid withdrawal. Transplantation. 2013 Feb 27;95(4):573-9. doi: 10.1097/TP.0b013e3182777efb. |
| 19307792 | Derived | Delgado JC, Fuller A, Ozawa M, Smith L, Terasaki PI, Shihab FS, Eckels DD. No occurrence of de novo HLA antibodies in patients with early corticosteroid withdrawal in a 5-year prospective randomized study. Transplantation. 2009 Feb 27;87(4):546-8. doi: 10.1097/TP.0b013e3181949d2e. |
| ID | Term |
|---|---|
| D016559 | Tacrolimus |
| D009173 | Mycophenolic Acid |
| D013256 | Steroids |
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
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