Lupus Nephritis (LN) Immunoglobulin A Nephropathy (IgAN)
Conditions
Brief summary
Percentage change in proteinuria
Detailed description
1) Percentage change in proteinuria 2) Achieving > 30% and > 50% reduction in proteinuria 3)Change from baseline in eGFR 4)PK/PD - Observed plasma concentrations of ALXN2050 5)PK/PD - Absolute values and change from baseline in plasma Bb concentration and serum AP activity 6) Safety - Incidence of TEAEs and TESAEs 7) Safety - Changes from baseline in laboratory assessments LN Cohort Only: 8) Meeting the criteria for complete renal response (CRR) 9) Meeting the criteria for partial renal response
Interventions
DRUGALXN 2050
DRUGALXN2050 Placebo Tablets
Sponsors
Alexion Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage change in proteinuria | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Percentage change in proteinuria 2) Achieving > 30% and > 50% reduction in proteinuria 3)Change from baseline in eGFR 4)PK/PD - Observed plasma concentrations of ALXN2050 5)PK/PD - Absolute values and change from baseline in plasma Bb concentration and serum AP activity 6) Safety - Incidence of TEAEs and TESAEs 7) Safety - Changes from baseline in laboratory assessments LN Cohort Only: 8) Meeting the criteria for complete renal response (CRR) 9) Meeting the criteria for partial renal response | — |
Countries
Germany, Italy, Spain
Outcome results
None listed