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ALXN2030 for antibody-mediated rejection after kidney transplant

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

Phase 2 Interventional Alexion Pharmaceuticals, Inc. · NCT06744647

This trial tests whether ALXN2030 helps people with active or chronic active antibody-mediated rejection after a kidney transplant improve biopsy findings over 52 weeks compared with placebo.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment45 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorAlexion Pharmaceuticals, Inc. Industry-sponsored
Locations55 sites (Birmingham, Alabama and 54 other locations)
Trial IDNCT06744647 on ClinicalTrials.gov

What this trial studies

This randomized, double-blind Phase 2 trial enrolls kidney transplant recipients with biopsy-proven active or chronic active antibody-mediated rejection and randomizes them 1:1:1 to two doses of ALXN2030 or placebo alongside standard immunosuppression. Participants receive blinded treatment for 52 weeks with protocol biopsies at Week 28 and Week 52 to measure histologic resolution, and may enter a 52-week open-label extension where placebo patients are re-randomized to active doses. The study will collect safety, pharmacokinetic, pharmacodynamic, and immunogenicity data throughout treatment and during a post-treatment safety follow-up. The primary endpoint is biopsy-proven histologic resolution at Week 52.

Who should consider this trial

Good fit: Ideal participants are adult kidney transplant recipients at least six months post-transplant with biopsy-proven active or chronic active AMR, MVI score ≥2, eGFR ≥30 mL/min/1.73 m2, body weight ≥50 kg, and up-to-date meningococcal, pneumococcal, and Hib vaccinations.

Not a fit: Patients with concurrent T-cell–mediated rejection, polyomavirus nephropathy, very low kidney function (eGFR <30 mL/min/1.73 m2), or other protocol exclusion criteria are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, ALXN2030 could improve biopsy findings and help preserve kidney graft function in patients with antibody-mediated rejection.

How similar studies have performed: Complement-targeting and other immune-modulating therapies have been tested in AMR with mixed results, and ALXN2030 represents a novel agent being explored in this context.

Eligibility criteria

Show full inclusion / exclusion criteria 
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, \< 90 days prior to the Screening Visit and during Screening, for Acute Rejection, AMR (including plasmapheresis, plasma exchange, IVIg, B-cell depleting therapy, IL inhibitors, proteasome inhibitors, high-dose corticosteroids \[except for tapering\]), HDS products with known hepatotoxic ingredients, TCMR (including T-cell depleting therapy), excluding the SoC immunosuppressant treatment which will be allowed and should be stable during the entire treatment.
* Known medical or psychological condition, including substance abuse or use disorder (including alcohol), or risk factor that may interfere with study participation, pose additional risk, or confound study outcomes

Where this trial is running

Birmingham, Alabama and 54 other locations

+5 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Antibody-Mediated RejectionKidney TransplantationBiopsy-proven Histologic ScoresAMRALXN2030Biopsy-proven histologic scores
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.