Phase 2 Study of ALXN2030 in Patients With Antibody-Mediated Rejection After Kidney Transplantation
NCT ID: NCT06744647
Last Updated: 2025-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
45 participants
INTERVENTIONAL
2025-03-07
2028-11-07
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Placebo will be administered during the Double-Blind Treatment Period of 52 weeks.
Placebo
Placebo will be administered SC.
ALXN2030 Dose A
During the Double-Blind Treatment Period, participants will receive ALXN2030 dose A over 52 weeks. At Week 52, participants may continue into the Open Label Extension (OLE).
ALXN2030
ALXN2030 will be administered subcutaneously (SC).
ALXN2030 Dose B
During the Double-Blind Treatment Period, participants will receive ALXN2030 dose B over 52 weeks. At Week 52, participants may continue into the OLE Period.
ALXN2030
ALXN2030 will be administered subcutaneously (SC).
Interventions
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ALXN2030
ALXN2030 will be administered subcutaneously (SC).
Placebo
Placebo will be administered SC.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Alexion Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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Research Site
Birmingham, Alabama, United States
Research Site
Scottsdale, Arizona, United States
Research Site
Los Angeles, California, United States
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Orange, California, United States
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Tampa, Florida, United States
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Atlanta, Georgia, United States
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Kansas City, Kansas, United States
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Ann Arbor, Michigan, United States
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Detroit, Michigan, United States
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Livingston, New Jersey, United States
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New York, New York, United States
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New York, New York, United States
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New York, New York, United States
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Stony Brook, New York, United States
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Durham, North Carolina, United States
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Cincinnati, Ohio, United States
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Philadelphia, Pennsylvania, United States
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Charleston, South Carolina, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Richmond, Virginia, United States
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Seattle, Washington, United States
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Milwaukee, Wisconsin, United States
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Botucatu, , Brazil
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Campinas, , Brazil
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Porto Alegre, , Brazil
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São Paulo, , Brazil
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São Paulo, , Brazil
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
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Vancouver, British Columbia, Canada
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London, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Changsha, , China
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Guangzhou, , China
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Nanning, , China
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Shanghai, , China
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Wuhan, , China
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Xi'an, , China
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Barcelona, , Spain
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Barcelona, , Spain
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Zaragoza, , Spain
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Kaohsiung City, , Taiwan
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Kaohsiung City, , Taiwan
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Taichung, , Taiwan
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Taoyuan District, , Taiwan
Research Site
Birmingham, , United Kingdom
Research Site
London, , United Kingdom
Countries
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Central Contacts
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Alexion Pharmaceuticals, Inc. (Sponsor)
Role: CONTACT
Phone: 1-855-752-2356
Email: [email protected]
Other Identifiers
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D8560C00002
Identifier Type: -
Identifier Source: org_study_id