Antibody-Mediated Rejection after Kidney Transplantation
Conditions
Brief summary
Biopsy-proven histologic resolution at Week 52
Detailed description
Biopsy-proven histologic resolution at Week 28., Resolution of AMR activity at Weeks 28 and 52., Change from baseline in biopsy-proven histologic score at Weeks 28 and 52., eGFR change from baseline at Week 52., Annualized total eGFR slope during 52 weeks of treatment., Stabilized eGFR (annualized eGFR slope > -1) during 52 weeks of treatment., Incidence of TEAEs and TESAEs over time., ALXN2030 plasma concentration over time., Absolute values, change from Baseline and percent change from Baseline in plasma concentrations of C3 protein over time and in serum complement functional activity over time., Anti-ALXN2030 Ab incidence, category of ADA response, and titer through the duration of the study.
Interventions
DRUGALXN2030
DRUGVialed Saline Placebo
Sponsors
Alexion Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Biopsy-proven histologic resolution at Week 52 | — |
Secondary
| Measure | Time frame |
|---|---|
| Biopsy-proven histologic resolution at Week 28., Resolution of AMR activity at Weeks 28 and 52., Change from baseline in biopsy-proven histologic score at Weeks 28 and 52., eGFR change from baseline at Week 52., Annualized total eGFR slope during 52 weeks of treatment., Stabilized eGFR (annualized eGFR slope > -1) during 52 weeks of treatment., Incidence of TEAEs and TESAEs over time., ALXN2030 plasma concentration over time., Absolute values, change from Baseline and percent change from Baseline in plasma concentrations of C3 protein over time and in serum complement functional activity over time., Anti-ALXN2030 Ab incidence, category of ADA response, and titer through the duration of the study. | — |
Countries
Spain
Outcome results
None listed