Phase 2 Study of ALXN2030 in Patients With Antibody-Mediated Rejection After Kidney Transplantation
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAlexion Pharmaceuticals, Inc.
About this trial
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.
Eligibility criteria
Qualifiers
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)
Disqualifiers
TCMR, according to the Banff grade ≥ 1
Polyoma virus nephropathy
Severe thrombotic microangiopathy
Glomerulonephritis
Trial design
Treatments tested in this trial
- ALXN2030
- Placebo
Treatment groups
45 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov