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Table 2 Randomized controlled studies in lupus nephritis

From: Lupus nephritis: current update

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
  1. AZA, azathioprine; CYC, cyclophosphamide; ESRD, end-stage renal disease; i.v., intravenous; LN, lupus nephritis; MMF, mycophenolate mofetil; p.o., oral; sCr, serum creatinine.