Phase 2 Study of ALXN2030 in Patients With Antibody-Mediated Rejection After Kidney Transplantation (CONCORD)
Actively Recruiting
About This Study
This Phase 2, randomized, double-blind, placebo-controlled trial evaluates the efficacy and safety of ALXN2030 in adult kidney transplant recipients with biopsy-proven active or chronic active antibody-mediated rejection (AMR). Participants are randomized 1:1:1 to receive ALXN2030 Dose A, ALXN2030 Dose B, or placebo for 52 weeks in addition to standard of care immunosuppression. The primary objective is to assess histologic resolution of AMR via repeat allograft biopsies at 28 and 52 weeks. Secondary outcomes include pharmacokinetics, immunogenicity, and long-term safety during a 52-week open-label extension.
Who Can Participate?
✓ 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 least 14 days prior to but no more than 3 years prior to Day 1
- •Must be vaccinated for S pneumoniae prior to randomization
- •Must be vaccinated for H influenzae type B (where available) prior to randomization
- •Body weight ≥ 50 kg at Screening
✗ Exclusion Criteria
- •Biopsy-based diagnosis of any of the following at Screening:
- •TCMR, according to the Banff grade ≥ 1
- •Polyoma virus nephropathy
- •Severe thrombotic microangiopathy
- •Glomerulonephritis
- •ABO-incompatible transplant
- •uACR > 2200 mg/g
- •Multiorgan transplant recipient (except for previous multiple kidney transplants) or cell transplant (islet, bone marrow, stem cell) recipient
- •Planned or recent treatments, < 3 months prior to the Screening Visit, for Acute Rejection, AMR (including plasmapheresis, plasma exchange, IVIg, B-cell depleting therapy, IL inhibitors, proteasome inhibitors, high-dose corticosteroids [except for tapering]), TCMR (including T-cell depleting therapy), excluding the SoC immunosuppressant treatment which will be allowed and should be stable during the entire treatment.