Table 3 An overview of major randomized controlled trials of lupus nephritis treatments currently in progress and their response criteria
ClinicalTrials. gov identifier | Sponsor | Study name | Study design | Lupus nephritis class | Intervention | Background therapy | Primary outcome | Patient enrollment goal, number | Sites, number | International or US only | Estimated completion date |
|---|---|---|---|---|---|---|---|---|---|---|---|
NCT01714817 | Bristol-Myers Squibb | ALLURE | Phase 3, randomized, double-blind, placebo-controlled | III or IV | Abatacept versus placebo | Corticosteroids + MMF | Proportion of subjects achieving complete renal response at 52 weeks defined as: | 400 | 98 | International | July 2017 |
1. Kidney function: eGFR normal or no less than 85% baseline | |||||||||||
2. Proteinuria: UPC ratio <0.5 | |||||||||||
3. Urine sediment: no cellular casts | |||||||||||
4. Corticosteroid dose: <11Â mg daily for at least 28Â days | |||||||||||
NCT01639339 | Human Genome Sciences Inc., a GSK Company | BLISS-LN | Phase 3, randomized, double-blind, placebo-controlled | III or IV and coexisting V if present | Belimumab versus placebo | Corticosteroids + CYC for induction therapy | Number of participants with complete renal response at 104 weeks defined as: | 464 | 102 | International | February 2017 |
1. Kidney function: eGFR no more than 10% below pre-flare value or normal | |||||||||||
-AZA for maintenance OR High-dose steroids + MMF for induction therapy | |||||||||||
-MMF for maintenance | 2. Proteinuria: UPC ratio <0.5 | ||||||||||
3. Urine sediment: inactive (<5 RBCs/WBCs, no casts) | |||||||||||
4. No rescue therapy | |||||||||||
|  | Biogen IDEC | ATLAS | Randomized, double-blind, placebo-controlled | III or IV and coexisting V if present | BIIB023 (anti-TWEAK) at high or low dose versus placebo | Corticosteroids + MMF | Proportion of subjects who achieve renal response (complete or partial) at 52 weeks | 300 | 123 | International | September 2016 |
NCT02141672 | Aurinia | AURA-LV | Randomized, double-blind, placebo-controlled | III, IV and/or V | Voclosporin at high or low dose versus placebo | Corticosteroids + MMF | Number of subjects who achieve complete remission at 24 weeks defined as: | 222 | 56 | Inter-national | December 2016 |
1. No confirmed decrease from baseline in eGFR of ≥20% | |||||||||||
2. Proteinuria: UPC ratio <0.5 |