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Mycophenolate mofetil versus tacrolimus for maintenance of remission in children with frequently relapsing and steroid-dependent nephrotic syndrome: a pilot randomized controlled trial
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Mycophenolate mofetil versus tacrolimus for maintenance of remission in children with frequently relapsing and steroid-dependent nephrotic syndrome: a pilot randomized controlled trial

Pediatric Nephrology·September 7
PediatricsLimited evidenceSafety signalFrequently Relapsing Nephrotic SyndromeSteroid-Dependent Nephrotic SyndromeRandomized Controlled TrialImmunosuppressantPediatricMycophenolate MofetilTacrolimus

Summary

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What was studied

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).

Key findings

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.

Study limitations

- 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.

Clinical implications

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.

Caveats

  • Level of evidence assigned as 2 (RCT) but the pilot/single-centre nature materially limits confidence; some would classify this as level 3.
  • Open-label design may introduce bias in secondary outcome assessments such as blood pressure and growth monitoring.
  • The 'Author contributions' section references different author initials (SD, BS, MB) inconsistent with the listed authors, suggesting a possible template error in the published manuscript.
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  • This is a pilot trial with only 40 patients; it is likely underpowered to detect differences in relapse rates and should be interpreted cautiously.

Related Questions

Explore related topics

What is the best steroid-sparing agent for children with steroid-dependent nephrotic syndrome?How does tacrolimus nephrotoxicity compare to mycophenolate mofetil in pediatric patients?IPNA and KDIGO guidelines for managing frequently relapsing nephrotic syndrome in children

Publication Details

Year
2026
Journal
Pediatric Nephrology
Sample Size
n=40
Source
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