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Clinical Trials in the UK / NCT06744647
Active, not recruiting Phase 2

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

NCT06744647 · tracked via the Priya Life Science UK tracker
Sponsor
Alexion Pharmaceuticals, Inc.
Phase
Phase 2
Started
2025-03-07
Last updated
2026-08-11

Condition(s) studied

Antibody-Mediated RejectionKidney TransplantationBiopsy-proven Histologic ScoresAMR

Investigational drug(s) / intervention(s)

ALXN2030Placebo

ALXN2030: ALXN2030 will be administered subcutaneously (SC).

Placebo: Placebo will be administered SC.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (51)

FacilityCityRegionStatus
Research Site Birmingham Alabama
Research Site Scottsdale Arizona
Research Site Los Angeles California
Research Site Orange California
Research Site Tampa Florida
Research Site Atlanta Georgia
Research Site Kansas City Kansas
Research Site Ann Arbor Michigan
Research Site Detroit Michigan
Research Site Livingston New Jersey
Research Site New York New York
Research Site New York New York
Research Site New York New York
Research Site Durham North Carolina
Research Site Cincinnati Ohio
Research Site Philadelphia Pennsylvania
Research Site Dallas Texas
Research Site Houston Texas
Research Site Richmond Virginia
Research Site Seattle Washington
Research Site Milwaukee Wisconsin
Research Site Botucatu Brazil
Research Site Campinas Brazil
Research Site Porto Alegre Brazil
Research Site São Paulo Brazil
Research Site São Paulo Brazil
Research Site Calgary Alberta
Research Site Edmonton Alberta
Research Site Vancouver British Columbia
Research Site London Ontario
Research Site Toronto Ontario
Research Site Changsha China
Research Site Guangzhou China
Research Site Nanning China
Research Site Shanghai China
Research Site Wuhan China
Research Site Xi'an China
Research Site Seoul South Korea
Research Site Seoul South Korea
Research Site Seoul South Korea

+ 11 more sites — see the full list on the official registry below.

More Alexion Pharmaceuticals, Inc. trials in the UK

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06744647 on ClinicalTrials.gov ↗ ← All trials in the UK