Drug and reference | Description | Primary endpoint | Number and type of patients | Follow-up duration | Results |
---|---|---|---|---|---|
CYC [118] | Patients randomized to i.v. CYC vs. p.o. CYC, p.o. CYC + AZA, AZA, or prednisone | Time to kidney failure | n = 107, mainly class III and IV LN | 7 years | Time to ESRD is significantly longer in patients receiving i.v. CYC compared with those receiving steroids alone |
CYC [121] | Patients randomized to high-dose (500 to 1,000 mg/m2) monthly i.v. CYC for 6 months vs. low-dose i.v. CYC regimen 500 mg every 2 weeks × six doses | Treatment failure (doubling of sCr, absence of primary response or occurrence of a flare) | n = 90, class IV LN, 85% Caucasian | 41 months | Induction therapy with low-dose CYC is as effective as high-dose CYC |
MMF [123] | Patients randomized to 6 months induction with MMF (2 g/day) or oral CYC (2.5 mg/kg/day) + prednisolone | Incidence of complete remission | n = 42, class IV LN, 100% Chinese | 12 months | Induction therapy with MMF is as effective as oral CYC |
MMF [124] | Patients randomized to monthly i.v. CYC or MMF (3 g/day) | Incidence of complete remission at 6 months | n = 140, class IV, 56% African American | 6 months | MMF was not inferior to i.v. CYC for induction of remission. In fact, MMF was more effective and better tolerated than i.v. CYC at inducing remission |
MMF [125] | Patients randomized to MMF or monthly i.v. CYC for induction | Prespecified decrease in urine protein/creatinine ratio and improvement in sCr | n = 370, classes III to V LN, 75% Caucasian | 6 months | MMF is not superior to i.v. CYC as induction therapy. No significant differences in response rate between the two groups. Adverse events were similar |
MMF [126] | Patients randomized to quarterly i.v. CYC, MMF, or AZA for maintenance after induction with i.v. CYC | Incidence of patient and kidney survival | n = 59, classes III and IV LN, African American and Hispanic | 72 months | MMF and AZA are both efficacious and safer than i.v. CYC for maintenance therapy |
AZA [126] | Patients randomized to quarterly i.v. CYC, MMF, or AZA for maintenance after induction with i.v. CYC | Incidence of patient and kidney survival | n = 59, classes III and IV LN, African American and Hispanic | 72 months | MMF and AZA are both efficacious and safer than i.v. CYC for maintenance therapy |
AZA, MMF [127] | Patients randomized to MMF, or AZA for maintenance after induction with low-dose i.v. CYC | Time to renal flares | n = 103, classes III and IV LN, European | Minimum 3 years | No significant difference in renal flares with MMF and AZA as maintenance therapy |
Rituximab (Rovin and colleagues, 2009) | Patients randomized to MMF or MMF + rituximab for induction therapy | Incidence of complete or partial renal remission | n = 144, classes III and IV LN | 52 weeks | Rituximab does not have an additive benefit to MMF for induction therapy |