{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,11,21]],"date-time":"2025-11-21T11:54:11Z","timestamp":1763726051623,"version":"3.32.0"},"reference-count":33,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2006,11,9]],"date-time":"2006-11-09T00:00:00Z","timestamp":1163030400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Clinical Transplantation"],"published-print":{"date-parts":[[2007,1]]},"abstract":"<jats:p><jats:bold>Abstract:\u2002<\/jats:bold><jats:bold>Background:\u2002<\/jats:bold>Maintenance steroid therapy is associated with significant morbidity and mortality in renal transplant recipients. Elimination of the many long\u2010term side effects of corticosteroids, including those that impinge on cardiovascular risk, remains a laudable goal in designing immunosuppressive protocols. However, concern persists that prednisone\u2010free maintenance immunotherapy in kidney transplant recipients will result in an increase incidence of acute rejections, renal dysfunction and ultimate graft loss.<\/jats:p><jats:p><jats:bold>Methods:\u2002<\/jats:bold>From 24 March 2003 to 1 December 2004, 84 kidney transplant recipients (61 deceased donor, 23 living donors) discontinued prednisone on post\u2010operative day 6. Immunotherapy consisted of polyclonal antibody induction (thymoglobulin) for five d and prednisone intraoperatively with a rapid taper over the next six d. Maintenance therapy consisted of a sirolimus and CellCept\u2010based calcineurin inhibitor\u2010minimization protocol. Tacrolimus and mycophenolate mofetil (CellCept) were initiated on day 0. Sirolimus immunotherpay was started on post\u2010operative day 6 concomitant with the cessation of steroids. We compared outcomes with that of our historical controls, treated with sirolimus and tacrolimus, who did not discontinue steroids. In addition, we analyzed outcomes independently for recipients of living and deceased donors in the steroid\u2010free protocol.<\/jats:p><jats:p><jats:bold>Results:\u2002<\/jats:bold>The recipients on prednisone\u2010free maintenance immunosuppression had excellent 2.5\u2010yr actuarial patient survival (97%), graft survival (93%), and acceptable acute rejection\u2010free graft survival (89%). The mean serum creatinine level (\u00b1SD) at one yr was 1.5\u2003\u00b1\u20030.6\u2003mg\/dL and at two yr was 1.5\u2003\u00b1\u20030.6\u2003mg\/dL. We noted that 5% of recipients developed cytomegalovirus (CMV) syndrome; 1%, polyoma nephropathy; 1%, post\u2010transplant lymphoproliferative disorder (PTLD), and 5% developed post\u2010transplant diabetes mellitus (PTDM). In all, 91% of kidney recipients with functioning grafts remain steroid\u2010free as of 31 December 2005. When compared with historical controls, the recipients on the early steroid\u2010withdrawal (ESW) protocol had comparable graft survival, acute rejection\u2010free survival, graft function, but significantly better patient actuarial survival (p\u2003=\u20030.048). In addition, recipients on the steroid\u2010free protocol had decreased prevalence of four risk factors for cardiovascular disease when compared with historical controls: hypertension (p\u2003=\u20030.008), hyperlipidemia (p\u2003=\u20030.003), weight gain (p\u2003=\u20030.024), and incidence of PTDM (p\u2003=\u20030.015).<\/jats:p><jats:p><jats:bold>Conclusion:\u2002<\/jats:bold>Early steroid\u2010withdrawal in renal transplant recipients with a sirolimus and CellCept\u2010based calcineurin inhibitor\u2010minimimization protocol can effectively reduce many of the steroid\u2010related side effects, decrease risk factors for cardiovascular disease, and is associated with improved recipient survival without compromising graft function.<\/jats:p>","DOI":"10.1111\/j.1399-0012.2006.00613.x","type":"journal-article","created":{"date-parts":[[2006,11,9]],"date-time":"2006-11-09T17:12:49Z","timestamp":1163092369000},"page":"101-109","source":"Crossref","is-referenced-by-count":50,"title":["Early steroid withdrawal therapy in renal transplant recipients: a steroid\u2010free sirolimus and CellCept\u2010based calcineurin inhibitor\u2010minimization protocol"],"prefix":"10.1111","volume":"21","author":[{"given":"James J","family":"Jaber","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Paul J","family":"Feustel","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ossama","family":"Elbahloul","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alexander D","family":"Conti","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michael H","family":"Gallichio","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David J","family":"Conti","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2007,1,2]]},"reference":[{"doi-asserted-by":"publisher","key":"e_1_2_5_2_2","DOI":"10.1097\/00042307-199903000-00006"},{"doi-asserted-by":"publisher","key":"e_1_2_5_3_2","DOI":"10.1056\/NEJMra033540"},{"doi-asserted-by":"publisher","key":"e_1_2_5_4_2","DOI":"10.1016\/j.jamcollsurg.2005.03.023"},{"key":"e_1_2_5_5_2","first-page":"385","article-title":"The reversal of rejection in human renal homografts with subsequent development of homograft tolerance","volume":"117","author":"Strazl TE","year":"1963","journal-title":"Surg Gynecol Obstet"},{"key":"e_1_2_5_6_2","doi-asserted-by":"crossref","first-page":"224","DOI":"10.1111\/j.1399-0012.1994.tb00245.x","article-title":"Steroid\u2010related complications in the cyclosporin era","volume":"8","author":"Fryer JP","year":"1994","journal-title":"Clin Transplant"},{"doi-asserted-by":"publisher","key":"e_1_2_5_7_2","DOI":"10.1016\/S0163-7258(02)00297-8"},{"doi-asserted-by":"publisher","key":"e_1_2_5_8_2","DOI":"10.1056\/NEJMra050541"},{"doi-asserted-by":"publisher","key":"e_1_2_5_9_2","DOI":"10.1016\/S0272-6386(12)80491-4"},{"key":"e_1_2_5_10_2","doi-asserted-by":"crossref","first-page":"1300","DOI":"10.1681\/ASN.V461300","article-title":"Steroid\u2010free immunosuppression in cyclosporine\u2010treated renal transplant recipients: a meta\u2010analysis","volume":"4","author":"Hirick DE","year":"1993","journal-title":"J Am Soc Nephrol"},{"key":"e_1_2_5_11_2","first-page":"200","article-title":"A meta\u2010analysis of immunosuppression withdrawal trials in renal transplantation","volume":"11","author":"Kasiske BL","year":"1910","journal-title":"J Am Soc Nephrol"},{"doi-asserted-by":"publisher","key":"e_1_2_5_12_2","DOI":"10.1097\/00007890-199912270-00009"},{"key":"e_1_2_5_13_2","first-page":"645","article-title":"Low\u2010dose steroid therapy in cyclosporine\u2010treated renal transplant recipients with well\u2010functioning grafts; 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