Phase 2 Study of ALXN2030 in Patients With Antibody-Mediated Rejection After Kidney Transplantation

Conditions de participation

• Sexe:

  ALL

• Âges admissibles:

  18 to 75

Critères de participation

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.