The Steroids In the Maintenance of remission of Proliferative Lupus nephritis (SIMPL) pilot trial

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dc.contributor.authorGalbraith, Lauren
dc.contributor.authorManns, Braden
dc.contributor.authorHemmelgarn, Brenda
dc.contributor.authorWalsh, Michael
dc.date.accessioned2015-07-07T21:10:40Z
dc.date.available2015-07-07T21:10:40Z
dc.date.issued2014-11-28
dc.descriptionPublisher’s version of article deposited according to BioMed Central license agreement http://www.biomedcentral.com/authors/license July 7, 2015.en_US
dc.description.abstractBackground Patients with proliferative lupus nephritis are at risk of frequent relapses. Whether low- dose prednisone prevents relapses is uncertain. Objectives We undertook a pilot RCT to determine the feasibility of a larger trial. Design Pilot randomized controlled trial. Setting Single center Canadian outpatient nephrology clinic. Patients Participants with systemic lupus erythematosus (SLE) and a history of class III or IV lupus nephritis that achieved at least partial remission and remained on prednisone were eligible. Measurements Feasibility: proportion of eligible patients randomized and adherence to tapering regimen. Clinical: occurrence of renal or major non-renal flare of SLE. Methods We conducted a blinded, two-parallel-group randomized controlled trial of prednisone 7.5 mg/day (continuation) compared to a matching placebo (withdrawal). Results Of nineteen eligible patients screened, 15 (79%) were recruited and randomized; 8 to prednisone continuation and seven to withdrawal. All participants adhered to the tapering protocol to their assigned withdrawal or low-dose maintenance target. Over 36 months, the primary outcome occurred in four (50%) patients in the continuation group (three renal and one major non-renal flare), compared with one patient (14%) in the withdrawal group (one renal flare). Three participants (38%) in the continuation group had minor flares, while no patients in the withdrawal group did. Limitations This pilot RCT was small and not designed to assess the efficacy or safety of maintenance with low-dose prednisone. Conclusions The high proportion of eligible patients recruited, and success of protocol adherence suggest a large trial of prednisone maintenance therapy compared to withdrawal is feasible. Trial registration Current Controlled Trials ISRCTN31327267.en_US
dc.description.refereedYesen_US
dc.description.sponsorshipSponsored by the Open Access Author’s Fund.en_US
dc.identifier.citationGalbraith, L., Manns, B., Hemmelgarn, B., & Walsh, M. (2014). The Steroids In the Maintenance of remission of Proliferative Lupus nephritis (SIMPL) pilot trial. Canadian journal of kidney health and disease, 1(1), 30.en_US
dc.identifier.doi10.1186/s40697-014-0030-9
dc.identifier.doihttp://dx.doi.org/10.11575/PRISM/33734
dc.identifier.urihttp://hdl.handle.net/1880/50544
dc.language.isoenen_US
dc.publisherCanadian Journal of Kidney Health and Diseaseen_US
dc.publisher.corporateUniversity of Calgary
dc.publisher.departmentMedicineen_US
dc.publisher.facultyMedicineen_US
dc.publisher.institutionUniversity of Calgaryen_US
dc.publisher.urlhttp://www.cjkhd.org/content/1/1/30en_US
dc.rightsAttribution 4.0 International*
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/*
dc.subjectSystemic lupus erythematosus (SLE)en_US
dc.subjectLupus nephritisen_US
dc.subjectPrednisoneen_US
dc.subjectRemissionen_US
dc.subjectRenal flareen_US
dc.titleThe Steroids In the Maintenance of remission of Proliferative Lupus nephritis (SIMPL) pilot trialen_US
dc.typejournal article
thesis.degree.disciplineCommunity Health Sciences
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