Four RCTs were included (n=168). Two studies used adequate methods of allocation concealment, one reported blinding and two reported intention-to-treat analysis; three reported no losses to follow-up and one reported a 6% loss.
Renal function: In two studies (n=66) of high-risk patients, mycophenolate mofetil was associated with a statistically significant increase in serum creatinine compared to placebo (weighted mean difference 0.17 μmol/L, 95% CI: 0.09 to 0.25, p<0.0001). No significant heterogeneity was found. In one study (n=40) in lower-risk patients, there was no statistically significant difference between mycophenolate mofetil and placebo in the overall rate of change in serum creatinine.
Proteinuria: In high-risk patients there was no statistically significant difference between mycophenolate mofetil and placebo in urinary excretion of protein (two studies), doubling of creatinine (two studies), partial remission (three studies) or end-stage renal failure (one study). In low-risk patients (one study, n=40), mycophenolate mofetil was associated with a statistically significant reduction in the time-average percentage change in proteinuria (p=0.003) and a significantly higher partial remission rate compared to ACEI/ARB (80% versus 30%, p=0.0019). In high risk patients (one study, n=62), mycophenolate mofetil was associated with a significant reduction in proteinuria (0.6 versus 1.4 g/day, p<0.05) and a significant increase in complete remission rates compared to prednisolone (44% versus 19%, p<0.05).
Adverse events: All studies reported that mycophenolate mofetil was well tolerated. Gastrointestinal disturbances were reported in 9% to 12% of mycophenolate mofetil patients, leukopenia in 0 to 5% and the total infection episode rate was 0 to 15%. No serious infections were reported in mycophenolate mofetil groups.