The Steroids In the Maintenance of remission of Proliferative Lupus nephritis (SIMPL) pilot trial
Date
2014-11-28
Journal Title
Journal ISSN
Volume Title
Publisher
Canadian Journal of Kidney Health and Disease
Abstract
Background
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.
Description
Publisher’s version of article deposited according to BioMed Central license agreement http://www.biomedcentral.com/authors/license July 7, 2015.
Keywords
Systemic lupus erythematosus (SLE), Lupus nephritis, Prednisone, Remission, Renal flare
Citation
Galbraith, 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.