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The Steroids in the Maintenance of Remission of Proliferative Lupus Nephritis (SIMPL) Pilot Trial
- Source :
- Canadian Journal of Kidney Health and Disease, Vol 1 (2014)
- Publication Year :
- 2014
- Publisher :
- SAGE Publishing, 2014.
-
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.
- Subjects :
- Diseases of the genitourinary system. Urology
RC870-923
Subjects
Details
- Language :
- English
- ISSN :
- 20543581
- Volume :
- 1
- Database :
- Directory of Open Access Journals
- Journal :
- Canadian Journal of Kidney Health and Disease
- Publication Type :
- Academic Journal
- Accession number :
- edsdoj.147646971f854ba9a22c8aaf381c061d
- Document Type :
- article
- Full Text :
- https://doi.org/10.1186/s40697-014-0030-9