Title
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Cyclosporine withdrawal from a mycophenolate mofetil-containing immunosuppressive regimen : results of a five-year, prospective, randomized study
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Author
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Institution/Organisation
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Cyclosporine Withdrawal Study Grp
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Abstract
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Maintenance immunosuppression with cyclosporine (CsA) is associated with nephrotoxicity, hyperlipidemia, and hypertension. This long-term study (core study + 4 yr of follow-up) investigated the long-term efficacy and safety of CsA withdrawal from a mycophenolate mofetil (MMF)-based regimen. Seventy-seven patients were maintained on CsA, MMF, and steroids (CsA-MMF group), and 74 were given a CsA-free regimen of MMF and steroids (MMF group). Serum creatinine and creatinine clearance were measured at 6-month intervals. Patient and graft survival, acute rejection episodes, malignancies, BP, and lipid profile were also recorded. At 5 yr, patient and graft survival was 93 and 88%, respectively, for the MMF group and 95 and 92%, respectively, for the CsA-MMF group. During follow-up, seven MMF patients experienced acute rejection episodes compared with one CsA-MMF patient (P = 0.0283). Nine grafts were lost to chronic rejection in the MMF group versus three in the CsA-MMF group. No demographic or immunologic characteristics were associated with acute or chronic rejection in the MMF group, but the doses of both MMF and steroids decreased significantly between 1 and 5 yr. The MMF group showed a trend toward improved creatinine clearance (67.4 versus 61.7 ml/min; P = 0.0500). Withdrawal of CsA from an MMF-containing immunosuppressive regimen resulted in an increased risk for acute rejection episodes and graft loss as a result of rejection throughout the 5-yr study period. The creatinine clearance- confirmed improvement in renal function observed at year 1 was maintained at 5 yr BP and cholesterol levels were well controlled in both groups. |
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Language
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English
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Source (journal)
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Journal of the American Society of Nephrology. - Baltimore, Md, 1990, currens
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Publication
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Baltimore, Md
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2005
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ISSN
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1046-6673
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DOI
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10.1681/ASN.2004100844
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Volume/pages
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16
:7
(2005)
, p. 2234-2240
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ISI
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000230046900045
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Full text (Publisher's DOI)
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Full text (publisher's version - intranet only)
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