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Mycophenolate mofetil versus cyclophosphamide for induction treatment of lupus nephritis

dc.contributor.authorAppel, G. B.
dc.contributor.authorContreras, G.
dc.contributor.authorDooley, M. A.
dc.contributor.authorGinzler, E. M.
dc.contributor.authorIsenberg, D.
dc.contributor.authorJayne, D.
dc.contributor.authorLi, L-S.
dc.contributor.authorMysler, E.
dc.contributor.authorSanchez-Guerrero, J.
dc.contributor.authorSolomons, N.
dc.contributor.authorWofsy, D.
dc.contributor.authorAbud, C.
dc.contributor.authorAdler, S.
dc.contributor.authorAlarcon, G.
dc.contributor.authorAlbuquerque, E.
dc.contributor.authorAlmeida, F.
dc.contributor.authorAlvarellos, A.
dc.contributor.authorAppel, G.
dc.contributor.authorAvila, H.
dc.contributor.authorBlume, C.
dc.contributor.authorBoletis, I.
dc.contributor.authorBonnardeaux, A.
dc.contributor.authorBraun, A.
dc.contributor.authorBuyon, J.
dc.contributor.authorCervera, R.
dc.contributor.authorChen, N.
dc.contributor.authorChen, S.
dc.contributor.authorDa Costa, A. G.
dc.contributor.authorDavids, M. R.
dc.contributor.authorD'Cruz, D.
dc.contributor.authorDe Ramon, E.
dc.contributor.authorDeodhar, A.
dc.contributor.authorDoria, A.
dc.contributor.authorDussol, B.
dc.contributor.authorEmery, P.
dc.contributor.authorFiechtner, J.
dc.contributor.authorFloege, J.
dc.contributor.authorFragoso-Loyo, H.
dc.contributor.authorFurie, R.
dc.contributor.authorGhazalli, R.
dc.contributor.authorGhossein, C.
dc.contributor.authorGilkeson, G.
dc.contributor.authorGinzler, E.
dc.contributor.authorGordon, C.
dc.contributor.authorGrossman, J.
dc.contributor.authorGu, J.
dc.contributor.authorGuillevin, L.
dc.contributor.authorHatron, P. Y.
dc.contributor.authorHerrera, G.
dc.contributor.authorHiepe, F.
dc.contributor.authorHoussiau, F.
dc.contributor.authorHubscher, O.
dc.contributor.authorHura, C.
dc.contributor.authorKaplan, J.
dc.contributor.authorKirsztajn, G.
dc.contributor.authorKiss, E.
dc.contributor.authorKutty, G. A.
dc.contributor.authorLaville, M.
dc.contributor.authorLazaro, M.
dc.contributor.authorLenz, O.
dc.contributor.authorLi, L.
dc.contributor.authorLightstone, L.
dc.contributor.authorLim, S.
dc.contributor.authorMalaise, M.
dc.contributor.authorManzi, S.
dc.contributor.authorMarcos, J.
dc.contributor.authorMeyer, O.
dc.contributor.authorMonge, P.
dc.contributor.authorNaicker, S.
dc.contributor.authorNeal, N.
dc.contributor.authorNeuwelt, M.
dc.contributor.authorNicholls, K.
dc.contributor.authorOlsen, N.
dc.contributor.authorOrdi-Ros, J.
dc.contributor.authorOstrov, B.
dc.contributor.authorPestana, M.
dc.contributor.authorPetri, M.
dc.contributor.authorPokorny, G.
dc.contributor.authorPourrat, J.
dc.contributor.authorQian, J.
dc.contributor.authorRadhakrishnan, J.
dc.contributor.authorRovin, B.
dc.contributor.authorRoman, J. S.
dc.contributor.authorShanahan, J.
dc.contributor.authorShergy, W.
dc.contributor.authorSkopouli, F.
dc.contributor.authorSpindler, A.
dc.contributor.authorStriebich, C.
dc.contributor.authorSundel, R.
dc.contributor.authorSwanepoel, C.
dc.contributor.authorSi, Y. T.
dc.contributor.authorTate, G.
dc.contributor.authorTesar, V.
dc.contributor.authorTikly, M.
dc.contributor.authorWang, H.
dc.contributor.authorYahya, R.
dc.contributor.authorYu, X.
dc.contributor.authorZhang, F.
dc.contributor.authorZoruba, D.
dc.date.accessioned2011-05-15T16:17:09Z
dc.date.available2011-05-15T16:17:09Z
dc.date.issued2009
dc.identifier.citationJournal of the American Society of Nephrology
dc.identifier.citation20
dc.identifier.citation5
dc.identifier.issn10466673
dc.identifier.other10.1681/ASN.2008101028
dc.identifier.urihttp://hdl.handle.net/10019.1/14098
dc.description.abstractRecent studies have suggested that mycophenolate mofetil (MMF) may offer advantages over intravenous cyclophosphamide (IVC) for the treatment of lupus nephritis, but these therapies have not been compared in an international randomized, controlled trial. Here, we report the comparison of MMF and IVC as induction treatment for active lupus nephritis in a multinational, two-phase (induction and maintenance) study. We randomly assigned 370 patients with classes III through V lupus nephritis to open-label MMF (target dosage 3 g/d) or IVC (0.5 to 1.0 g/m2 in monthly pulses) in a 24-wk induction study. Both groups received prednisone, tapered from a maximum starting dosage of 60 mg/d. The primary end point was a prespecified decrease in urine protein/creatinine ratio and stabilization or improvement in serum creatinine. Secondary end points included complete renal remission, systemic disease activity and damage, and safety. Overall, we did not detect a significantly different response rate between the two groups: 104 (56.2%) of 185 patients responded to MMF compared with 98 (53.0%) of 185 to IVC. Secondary end points were also similar between treatment groups. There were nine deaths in the MMF group and five in the IVC group. We did not detect significant differences between the MMF and IVC groups with regard to rates of adverse events, serious adverse events, or infections. Although most patients in both treatment groups experienced clinical improvement, the study did not meet its primary objective of showing that MMF was superior to IVC as induction treatment for lupus nephritis. Copyright © 2009 by the American Society of Nephrology.
dc.subjectcreatinine
dc.subjectcyclophosphamide
dc.subjectmycophenolic acid 2 morpholinoethyl ester
dc.subjectprednisone
dc.subjectdrug derivative
dc.subjectimmunosuppressive agent
dc.subjectmycophenolic acid
dc.subjectabdominal pain
dc.subjectadolescent
dc.subjectadult
dc.subjectaged
dc.subjectalopecia
dc.subjectanemia
dc.subjectarthralgia
dc.subjectarticle
dc.subjectbackache
dc.subjectchild
dc.subjectclinical trial
dc.subjectcontrolled clinical trial
dc.subjectcontrolled study
dc.subjectcoughing
dc.subjectcreatinine blood level
dc.subjectcreatinine urine level
dc.subjectdiarrhea
dc.subjectdrug dose reduction
dc.subjectdrug dose titration
dc.subjectdrug efficacy
dc.subjectdrug eruption
dc.subjectdrug induced headache
dc.subjectdrug safety
dc.subjectdrug withdrawal
dc.subjectfemale
dc.subjecthuman
dc.subjecthypertension
dc.subjectlupus erythematosus nephritis
dc.subjectmajor clinical study
dc.subjectmale
dc.subjectmulticenter study
dc.subjectmuscle spasm
dc.subjectnausea
dc.subjectperipheral edema
dc.subjectpriority journal
dc.subjectrandomized controlled trial
dc.subjectremission
dc.subjectrhinopharyngitis
dc.subjectschool child
dc.subjecttreatment response
dc.subjecturinary tract infection
dc.subjectvomiting
dc.subjectethnic group
dc.subjectglomerulus filtration rate
dc.subjectintravenous drug administration
dc.subjectmortality
dc.subjectpathology
dc.subjectrace
dc.subjecttreatment outcome
dc.subjectContinental Population Groups
dc.subjectCyclophosphamide
dc.subjectEthnic Groups
dc.subjectFemale
dc.subjectGlomerular Filtration Rate
dc.subjectHumans
dc.subjectImmunosuppressive Agents
dc.subjectInjections, Intravenous
dc.subjectLupus Nephritis
dc.subjectMale
dc.subjectMycophenolic Acid
dc.subjectTreatment Outcome
dc.titleMycophenolate mofetil versus cyclophosphamide for induction treatment of lupus nephritis
dc.typeArticle
dc.description.versionArticle


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