Table 1.

Selected trials evaluating calcineurin inhibitors in lupus nephritis

TrialDesignNOutcome MeasureTreatment ArmsFollow-Up DurationResponse Rate
Moroni et al. 2006 (11)RCT75Kidney flareCyclosporin versus azathioprine4 yrCyclosporin: 10.6 flares/100 patient yr; azathioprine: 13.4 flares/100 patient yr
Bao et al. 2008 (18)RCT40Complete remissionTacrolimus/MMF versus iv cyclophosphamide9 moTacrolimus/MMF: 65% complete remission; iv cyclophosphamide: 15% complete remission
Zavada et al. 2010 (10)RCT40Complete remission, overall responseCyclosporin versus cyclophosphamide18 moCyclosporin: 37% complete remission, 58% response; cyclophosphamide: 14% complete remission, 38% response
Yap et al. 2012 (17)RCT16Complete remission, partial remission, overall remissionTacrolimus versus MMF24 moTacrolimus: overall 55.6%; MMF: overall 71.4%
Li et al. 2012 (13)RCT60Complete remission, partial remission, overall remissionTacrolimus versus cyclophosphamide versus MMF24 wkCyclophosphamide: 60% overall; MMF: 75% overall; tacrolimus: 75% overall
Mok et al. 2013 (22)Observational21Kidney responseTacrolimus/MMF (no control group)12 mo67% kidney response, 33% no response
Liu et al. 2015 (19)RCT362Complete remissionTacrolimus/MMF versus cyclophosphamide24 wkTacrolimus/MMF: 45.9% complete remission, 83.5% overall; cyclophosphamide: 25.6% complete remission, 63.0% overall
Mok et al. 2016 (14)RCT150Complete remission at 6 moTacrolimus versus MMF × 6 mo; both azathioprine after24 wk for induction phase, 5-yr maintenanceMMF: 59% complete remission; tacrolimus: 62% complete remission after induction; MMF: 38% kidney flare versus tacrolimus: 54% kidney flare during maintenance
Zhang et al. 2017 (21)RCT206Kidney relapse rateTacrolimus/MMF versus azathioprine (maintenance of Liu et al. 2015 [19])18 moTacrolimus/MMF: 5.47% kidney relapse; azathioprine: 7.62% kidney relapse
Rovin et al. 2019 (27)RCT265Complete remissionHigh-dose voclosporin + MMF versus low-dose voclosporin + MMF versus MMF48 wkLow-dose voclosporin: 49.4% complete remission; high-dose voclosporin: 39.8% complete remission; MMF: 23.9% complete remission
  • RCT, randomized, control trial; MMF, mycophenolate mofetil.