Systemic lupus erythematosus and active lupus nephritis
Conditions
Brief summary
CRR at Week 76, defined as (both must be met): • Urine protein to creatinine ratio (UPCR) ≤ 0.5 mg/mg AND • No decrease from baseline of ≥ 20% in estimated glomerular filtration rate (eGFR)
Detailed description
CRR at Week 76 with oral daily dose of 5 mg/day prednisone equivalent or less from Week 24 onwards, Sustained CRR at Week 76. Sustained CRR is defined as participant meeting CRR criteria for two consecutive visits (i.e., 3 months apart) and confirmed at Week 76 visit. The second consecutive visit can be the Week 76 visit to qualify as sustained CRR
Interventions
Sponsors
Viatris Innovation GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CRR at Week 76, defined as (both must be met): • Urine protein to creatinine ratio (UPCR) ≤ 0.5 mg/mg AND • No decrease from baseline of ≥ 20% in estimated glomerular filtration rate (eGFR) | — |
Secondary
| Measure | Time frame |
|---|---|
| CRR at Week 76 with oral daily dose of 5 mg/day prednisone equivalent or less from Week 24 onwards, Sustained CRR at Week 76. Sustained CRR is defined as participant meeting CRR criteria for two consecutive visits (i.e., 3 months apart) and confirmed at Week 76 visit. The second consecutive visit can be the Week 76 visit to qualify as sustained CRR | — |
Outcome results
None listed