- Design
- Prospective Asian multicentre randomised trial, 96 weeks
- Population
- 130 patients with biopsy-proven class III/IV ± V lupus nephritis
- Primary outcome
- Sustained renal response at week 96
- Effect
- 58.5% (tacrolimus) vs 69.2% (mycophenolate), not significant; serious infections more frequent with mycophenolate
This 96-week Asian multicentre randomised trial enrolled 130 people with biopsy-proven class III/IV, with or without class V, lupus nephritis. All received intravenous methylprednisolone then oral prednisolone, plus either tacrolimus (trough 6 to 8 ng/mL) or mycophenolate mofetil 1 g twice daily, as continuous induction and maintenance. Published in Kidney International on 28 September 2026.
Sustained renal response at 96 weeks was 58.5% with tacrolimus and 69.2% with mycophenolate, and complete remission 55.4% versus 63.1%; neither difference was significant. Overall adverse events were identical at 80%. Acute kidney injury and tremor were more common with tacrolimus, leucopenia with mycophenolate. Treatment-related serious adverse events and serious infections were significantly more common with mycophenolate, and all three deaths occurred in that group.
Tacrolimus is widely used for lupus nephritis in Asia, including India, and costs less than some newer options. This trial supports it as an alternative, particularly where infection risk or cytopenias dominate.
The efficacy figures numerically favour mycophenolate, and with 65 patients per arm the trial cannot exclude a real difference. Guidelines have not changed.
- Consider tacrolimus with steroids for lupus nephritis when infection risk or leucopenia is a concern
- Keep mycophenolate as the default where it is tolerated
- Monitor tacrolimus troughs, creatinine and tremor; target 6 to 8 ng/mL as in this trial
- Check blood counts and screen for infection regularly on mycophenolate
- Avoid mycophenolate in women planning pregnancy; tacrolimus is compatible
Why it matters
The choice between the two drugs can be made on each patient's side-effect risks rather than on efficacy alone.
Don't overread it
Not designed to show equivalence; the numerically lower response with tacrolimus could be real.
The statistics, in plain English
A 10-point gap in sustained response (58.5% vs 69.2%) did not reach significance with 65 patients per group, which means the trial was too small to tell whether the drugs differ by that much.
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