The Steroids in the Maintenance of Remission of Proliferative Lupus Nephritis (SIMPL) Pilot Trial
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 cente...
| Main Authors: | , , , |
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| Format: | Article |
| Language: | English |
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SAGE Publishing
2014-11-01
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| Series: | Canadian Journal of Kidney Health and Disease |
| Online Access: | https://doi.org/10.1186/s40697-014-0030-9 |
| _version_ | 1818313629061087232 |
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| author | Lauren Galbraith Braden Manns Brenda Hemmelgarn Michael Walsh |
| author_facet | Lauren Galbraith Braden Manns Brenda Hemmelgarn Michael Walsh |
| author_sort | Lauren Galbraith |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-12-13T08:36:47Z |
| format | Article |
| id | doaj.art-147646971f854ba9a22c8aaf381c061d |
| institution | Directory Open Access Journal |
| issn | 2054-3581 |
| language | English |
| last_indexed | 2024-12-13T08:36:47Z |
| publishDate | 2014-11-01 |
| publisher | SAGE Publishing |
| record_format | Article |
| series | Canadian Journal of Kidney Health and Disease |
| spelling | doaj.art-147646971f854ba9a22c8aaf381c061d2022-12-21T23:53:37ZengSAGE PublishingCanadian Journal of Kidney Health and Disease2054-35812014-11-01110.1186/s40697-014-0030-9The Steroids in the Maintenance of Remission of Proliferative Lupus Nephritis (SIMPL) Pilot TrialLauren Galbraith0Braden Manns1Brenda Hemmelgarn2Michael Walsh3 Department of Medicine, University of Calgary, Calgary, Canada Libin Cardiovascular Institute and Institute for Population Health, University of Calgary, Calgary, AB, Canada Libin Cardiovascular Institute and Institute for Population Health, University of Calgary, Calgary, AB, Canada Population Health Research Institute, McMaster University/Hamilton Health Sciences, Hamilton, CanadaBackground: 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.https://doi.org/10.1186/s40697-014-0030-9 |
| spellingShingle | Lauren Galbraith Braden Manns Brenda Hemmelgarn Michael Walsh The Steroids in the Maintenance of Remission of Proliferative Lupus Nephritis (SIMPL) Pilot Trial Canadian Journal of Kidney Health and Disease |
| title | The Steroids in the Maintenance of Remission of Proliferative Lupus Nephritis (SIMPL) Pilot Trial |
| title_full | The Steroids in the Maintenance of Remission of Proliferative Lupus Nephritis (SIMPL) Pilot Trial |
| title_fullStr | The Steroids in the Maintenance of Remission of Proliferative Lupus Nephritis (SIMPL) Pilot Trial |
| title_full_unstemmed | The Steroids in the Maintenance of Remission of Proliferative Lupus Nephritis (SIMPL) Pilot Trial |
| title_short | The Steroids in the Maintenance of Remission of Proliferative Lupus Nephritis (SIMPL) Pilot Trial |
| title_sort | steroids in the maintenance of remission of proliferative lupus nephritis simpl pilot trial |
| url | https://doi.org/10.1186/s40697-014-0030-9 |
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