title: The Steroids In the Maintenance of remission of Proliferative Lupus nephritis (SIMPL) pilot trial.
abstract: BACKGROUND
  Patients with proliferative lupus nephritis are at risk of frequent relapses. Whether low- dose prednisone prevents relapses is uncertain.
  
  
  OBJECTIVE
  We undertook a pilot RCT to determine the feasibility of a larger trial.
  
  
  METHODS
  Pilot randomized controlled trial.
  
  
  METHODS
  Single center Canadian outpatient nephrology clinic.
  
  
  METHODS
  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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  Current Controlled Trials ISRCTN31327267.
authors.affiliation: Department of Medicine, University of Calgary, Calgary, Canada.
authors.forename: Lauren
authors.initials: L
authors.lastname: Galbraith
authors.affiliation: Department of Medicine, University of Calgary, Calgary, Canada ; Department of Community Health Sciences, University of Calgary, Calgary, Canada ; Interdisciplinary Chronic Disease Collaboration, Calgary, Canada ; Libin Cardiovascular Institute and Institute for Population Health, University of Calgary, Calgary, AB Canada.
authors.forename: Braden
authors.initials: B
authors.lastname: Manns
authors.affiliation: Department of Medicine, University of Calgary, Calgary, Canada ; Department of Community Health Sciences, University of Calgary, Calgary, Canada ; Interdisciplinary Chronic Disease Collaboration, Calgary, Canada ; Libin Cardiovascular Institute and Institute for Population Health, University of Calgary, Calgary, AB Canada.
authors.forename: Brenda
authors.initials: B
authors.lastname: Hemmelgarn
authors.affiliation: Departments of Medicine and Clinical Epidemiology & Biostatistics, McMaster University, Hamilton, Canada ; Population Health Research Institute, McMaster University/Hamilton Health Sciences, Hamilton, Canada.
authors.forename: Michael
authors.initials: M
authors.lastname: Walsh
keywords: Lupus nephritis; Prednisone; Remission; Renal flare; Systemic lupus erythematosus (SLE)