A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate Efficacy and Safety of ALXN2030 in Adult Patients With Antibody-Mediated Rejection After Kidney Transplantation
Alexion Pharmaceuticals, Inc.
Summary
The primary objective of this study is to evaluate the efficacy of ALXN2030 compared with placebo on biopsy proven histologic resolution in participants with active or chronic active antibody-mediated rejection (AMR) at Week 52.
Description
This prospective trial will assess the efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of ALXN2030 in kidney transplant recipients with active or chronic active AMR. The study is designed as a randomized, controlled, double-blind phase 2 trial. Participants will be randomized in a 1:1:1 ratio to receive either ALXN2030 Dose A, ALXN2030 Dose B, or placebo for a double-blind treatment period of 52 weeks. All arms will receive standard of care immunosuppressive treatment. During the treatment period, study participants will be subjected to repeated allograft biopsies at 2…
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Kidney transplant received ≥ 6 months * Active or chronic active AMR according to Banff 2022 classification, based on Screening kidney biopsy * Either positive C4d on Screening kidney biopsy based on the Central Pathology Laboratory report and/or positive HLA Class I and/or II antigen-specific DSA as determined by the local laboratory's definition of positivity using single-antigen bead based assays * MVI score ≥ 2 (g ≥ 1 and ptc ≥ 1) * eGFR ≥ 30 mL/min/1.73 m2 * Must be vaccinated against meningococcal infection from serogroups A, C, W, Y (and B where available) at leas…
Interventions
- DrugALXN2030
ALXN2030 will be administered subcutaneously (SC).
- DrugPlacebo
Placebo will be administered SC.
Locations (55)
- Research SiteBirmingham, Alabama
- Research SiteScottsdale, Arizona
- Research SiteLos Angeles, California
- Research SiteOrange, California
- Research SiteTampa, Florida
- Research SiteAtlanta, Georgia