Open
Actively Recruiting
Phase 2 Study of ALXN2030 in Patients With Antibody-Mediated Rejection After Kidney Transplantation
About
Brief 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.
Primary Purpose
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
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.
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Study Stats
Protocol No.
25-0383
Category
Immune System/Transplant Related Disorders
Principal Investigator
Contact
Location
- UCLA Westwood