This pilot RCT compared mycophenolate mofetil (MMF, 1200 mg/m²/day) vs. tacrolimus (TAC, 0.1–0.15 mg/kg/day) for maintaining remission in 40 children aged 2–18 years with FRNS or SDNS at a single tertiary centre in India over 12 months (October 2023–March 2025).
Relapse-free survival at 6 months and overall relapse rates at 12 months were similar between MMF and TAC. However, TAC was associated with significantly higher serum creatinine, lower eGFR, higher blood pressure, higher BMI, and lower growth velocity compared to MMF.
- Very small pilot study (n=40, 20 per arm) at a single centre in India, limiting generalizability. - Open-label design introduces potential for performance and detection bias. - Short 12-month follow-up may not capture long-term nephrotoxicity or relapse differences.
MMF and TAC appear equally effective at preventing relapses in children with FRNS/SDNS, but TAC carries a less favourable safety profile—particularly for kidney function, blood pressure, and growth. Clinicians may prefer MMF for long-term steroid-sparing therapy pending larger trial data.
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