ALMS
Trial question
What is the role of mycophenolate mofetil in patients with class III to V lupus nephritis?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
85.0% female
15.0% male
N = 370
370 patients (313 female, 57 male)
Inclusion criteria: patients with class III to V lupus nephritis undergoing induction treatment
Key exclusion criteria: insufficient proteinuria, concurrent infection or illness, pregnancy, prohibited concurrent medication, low WBC count, > 6 months from renal biopsy, or unwilling to provide consent
Interventions
N=185 mycophenolate mofetil (target dosage 3 g/d plus prednisone, tapered from a maximum starting dosage of 60 mg/d)
N=185 intravenous cyclophosphamide (0.5 to 1.0 g/m² in monthly pulses plus prednisone, tapered from a maximum starting dosage of 60 mg/d)
Primary outcome
Percentage of patients achieving urine protein/creatinine ratio reduction and stabilization or reduction in serum creatinine
56.2
53
56.2 %
42.2 %
28.1 %
14.1 %
0.0 %
Mycophenolate mofetil
Intravenous cyclophosphamide
No significant difference ↔
No significant difference in the percentage of patients achieving urine protein/creatinine ratio reduction and stabilization or reduction in serum creatinine (56.2% vs. 53%; OR 1.2, 95% CI 0.8 to 1.8)
Secondary outcomes
No significant difference in the percentage of patients achieving normal serum creatinine at 24 weeks (70.3% vs. 67.6%; ARD 2.7, 95% CI -6.7 to 12.1)
Safety outcomes
No significant differences in rates of adverse events, serious adverse events, or infections.
Conclusion
In patients with class III to V lupus nephritis undergoing induction treatment, mycophenolate mofetil was not superior to intravenous cyclophosphamide with respect to the percentage of patients achieving urine protein/creatinine ratio reduction and stabilization or reduction in serum creatinine.
Reference
Appel GB, Contreras G, Dooley MA et al. Mycophenolate mofetil versus cyclophosphamide for induction treatment of lupus nephritis. J Am Soc Nephrol. 2009 May;20(5):1103-12.
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