Randomized Controlled Trial on the Efficacy of Reduced-Dose Cyclical Corticosteroids and Cyclophosphamide in Primary Membranous Nephropathy.
A lower-dose version of the standard steroid-plus-cyclophosphamide treatment for membranous nephropathy worked about as well at putting the disease into remission, with fewer side effects.
Background
Cyclophosphamide with corticosteroids is effective for membranous nephropathy but carries significant safety concerns; retrospective studies suggested a lower dose might suffice.
Study design
114 patients were randomised to low-dose (prednisolone 0.5 mg/kg/d in months 1, 3, 5 with oral cyclophosphamide 1.0-1.5 mg/kg/d in months 2, 4, 6) or standard-dose therapy (adding IV methylprednisolone 1 g/d for 3 days and cyclophosphamide 2.0-2.5 mg/kg/d). The primary outcome was complete or partial remission between months 6 and 24.
Key findings
In the intention-to-treat analysis, 45 (78.94%) low-dose and 50 (87.71%) standard-dose participants reached the primary outcome (difference -8.78%; 97.5% CI lower limit -22%), meeting noninferiority (P = 0.009).
Safety
At least one adverse event occurred in 78.94% of the low-dose group versus 96.49% of the standard-dose group (difference -17.54%).
Category
Research
Source
Kidney International Reports
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