Lupus Nephritis Class III-IV, +/- V
Conditions
Brief summary
Part 1 and 2: Proportion of patients achieving Complete Renal Response (CRR) at week 24 in the absence of renal flares
Detailed description
Parts 1 and 2: Proportion of patients achieving CRR or PRR in the absence of renal flares at weeks 24 and 52, Time-to-Complete Renal Response (CRR) based on first morning void (FMV) urine samples, Proportion of patients achieving ≥25% UPCR reduction in the absence of renal flares compared to baseline at week 24, Frequency of courses of corticosteroids for renal and non-renal indications at a dose exceeding an average of 20mg/day (of prednisolone or equivalent) for more than 10 days between weeks 24 and 52, Change from baseline FACIT-Fatigue Score at weeks 24 and 52, Change from baseline in SLEDAI-2K score at weeks 24 and 52, Change from baseline in BILAG-2004 score at weeks 24 and 52, Safety endpoints up to week 52 for Part 1 and 2, Log-transformed ratio to baseline of 24h UPCR at week 24
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part 1 and 2: Proportion of patients achieving Complete Renal Response (CRR) at week 24 in the absence of renal flares | — |
Secondary
| Measure | Time frame |
|---|---|
| Parts 1 and 2: Proportion of patients achieving CRR or PRR in the absence of renal flares at weeks 24 and 52, Time-to-Complete Renal Response (CRR) based on first morning void (FMV) urine samples, Proportion of patients achieving ≥25% UPCR reduction in the absence of renal flares compared to baseline at week 24, Frequency of courses of corticosteroids for renal and non-renal indications at a dose exceeding an average of 20mg/day (of prednisolone or equivalent) for more than 10 days between weeks 24 and 52, Change from baseline FACIT-Fatigue Score at weeks 24 and 52, Change from baseline in SLEDAI-2K score at weeks 24 and 52, Change from baseline in BILAG-2004 score at weeks 24 and 52, Safety endpoints up to week 52 for Part 1 and 2, Log-transformed ratio to baseline of 24h UPCR at week 24 | — |
Countries
France, Germany, Hungary, Portugal, Spain