Tacrolimus or Mycophenolate Mofetil for Frequently Relapsing or Steroid-Dependent Nephrotic Syndrome: A Randomized Clinical Trial
In a multicenter Chinese trial of 270 children with frequently relapsing or steroid-dependent nephrotic syndrome, one year of tacrolimus kept substantially more children relapse-free than mycophenolate mofetil, with a similar safety profile and lower steroid exposure.
Study design
Multicenter, open-label randomized clinical trial at 12 pediatric nephrology centers in China. 270 children aged 2-18 years with frequently relapsing (FRNS) or steroid-dependent (SDNS) nephrotic syndrome were randomized 1:1 to tacrolimus (0.025-0.050 mg/kg twice daily) or MMF (10-15 mg/kg twice daily) for 1 year alongside a steroid taper, with 1-year relapse-free survival as the primary endpoint.
Key findings
Tacrolimus achieved a 1.86-fold higher 1-year relapse-free survival than MMF (intention-to-treat HR 2.86; 95% CI 1.79-4.76; P<.001), a longer mean time to first relapse (324 vs 263 days), a lower annual relapse rate (17.8% vs 41.5%), and a lower mean cumulative steroid dose (0.22 vs 0.34 mg/kg/day).
Safety
The safety profile was similar between the tacrolimus and MMF groups over the 1-year treatment period.
Clinical implications
For FRNS/SDNS in children, tacrolimus appears more effective than MMF at maintaining remission over a year while reducing steroid exposure, directly informing the glucocorticoid-sparing agent choice emphasized in current guidelines.
Category
Research
Source
JAMA Pediatrics
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