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

Last updated: December 1, 2025
Sponsor: Alexion Pharmaceuticals, Inc.
Overall Status: Active - Recruiting

Phase

2

Condition

Kidney Transplantation

Transplant Rejection

Nephritis

Treatment

ALXN2030

Placebo

Clinical Study ID

NCT06744647
D8560C00002
  • Ages 18-75
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  • Kidney transplant received ≥ 6 months

  • Active or chronic active AMR according to Banff 2022 classification, based onScreening kidney biopsy

  • Either positive C4d on Screening kidney biopsy based on the Central PathologyLaboratory report and/or positive HLA Class I and/or II antigen-specific DSA asdetermined by the local laboratory's definition of positivity using single-antigenbead 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 Bwhere 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

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) orcell transplant (islet, bone marrow, stem cell) recipient

  • Planned or recent treatments, < 3 months prior to the Screening Visit, for AcuteRejection, AMR (including plasmapheresis, plasma exchange, IVIg, B-cell depletingtherapy, IL inhibitors, proteasome inhibitors, high-dose corticosteroids [except fortapering]), TCMR (including T-cell depleting therapy), excluding the SoCimmunosuppressant treatment which will be allowed and should be stable during theentire treatment.

Study Design

Total Participants: 45
Treatment Group(s): 2
Primary Treatment: ALXN2030
Phase: 2
Study Start date:
March 07, 2025
Estimated Completion Date:
November 07, 2028

Study Description

This prospective trial will assess the efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of ALXN2030 in kidney transplant recipients with active or chronic active AMR. The study is designed as a randomized, controlled, double-blind phase 2 trial. Participants will be randomized in a 1:1:1 ratio to receive either ALXN2030 Dose A, ALXN2030 Dose B, or placebo for a double-blind treatment period of 52 weeks. All arms will receive standard of care immunosuppressive treatment. During the treatment period, study participants will be subjected to repeated allograft biopsies at 28 and 52 weeks. At the end of the double-blind treatment period, participants may continue into the Open-Label Extension (OLE) Treatment Period (52 weeks). Participants randomized to placebo will be re-randomized 1:1 to ALXN2030 Dose A or ALXN2030 Dose B. Safety Follow-Up will start after the end of Treatment (Week 104) until week 48 after the last dose.

Connect with a study center

  • Research Site

    Botucatu, 18618-687
    Brazil

    Site Not Available

  • Research Site

    Botucatu 3469136, 18618-687
    Brazil

    Site Not Available

  • Research Site

    Campinas, 13083
    Brazil

    Site Not Available

  • Research Site

    Campinas 3467865, 13083
    Brazil

    Site Not Available

  • Research Site

    Porto Alegre, 90020-090
    Brazil

    Site Not Available

  • Research Site

    Porto Alegre 3452925, 90020-090
    Brazil

    Active - Recruiting

  • Research Site

    Sao Paulo, 05403-900
    Brazil

    Site Not Available

  • Research Site

    São Paulo, 04038-002
    Brazil

    Site Not Available

  • Research Site

    São Paulo 3448439, 04038-002
    Brazil

    Site Not Available

  • Research Site

    Edmonton, Alberta T6G 2R7
    Canada

    Site Not Available

  • Research Site

    Calgary 5913490, Alberta 5883102 T2N 1N4
    Canada

    Site Not Available

  • Research Site

    Edmonton 5946768, Alberta 5883102 T6G 2R7
    Canada

    Active - Recruiting

  • Research Site

    Vancouver 6173331, British Columbia 5909050 V6Z 1Y6
    Canada

    Site Not Available

  • Research Site

    London, Ontario N6A 5A5
    Canada

    Site Not Available

  • Research Site

    Toronto, Ontario M5G 2N2
    Canada

    Site Not Available

  • Research Site

    London 6058560, Ontario 6093943 N6A 5A5
    Canada

    Active - Recruiting

  • Research Site

    Toronto 6167865, Ontario 6093943 M5G 2N2
    Canada

    Site Not Available

  • Research Site

    Montreal, Quebec H4A 3J1
    Canada

    Site Not Available

  • Research Site

    Montreal 6077243, Quebec 6115047 H4A 3J1
    Canada

    Site Not Available

  • Research Site

    Changsha, 430033
    China

    Site Not Available

  • Research Site

    Changsha 1815577, 430033
    China

    Site Not Available

  • Research Site

    Guangzhou, 510080
    China

    Site Not Available

  • Research Site

    Guangzhou 1809858, 510080
    China

    Site Not Available

  • Research Site

    Nanning, 530007
    China

    Site Not Available

  • Research Site

    Nanning 1799869, 530007
    China

    Site Not Available

  • Research Site

    Shanghai, 201114
    China

    Site Not Available

  • Research Site

    Shanghai 1796236, 201114
    China

    Site Not Available

  • Research Site

    Wuhan, 430030
    China

    Site Not Available

  • Research Site

    Wuhan 1791247, 430030
    China

    Site Not Available

  • Research Site

    Xi'an 1790630, 710061
    China

    Site Not Available

  • Research Site

    Xian, 710061
    China

    Site Not Available

  • Research Site

    Seoul, 06591
    Korea, Republic of

    Site Not Available

  • Research Site

    Seoul 1835848, 06351
    South Korea

    Active - Recruiting

  • Research Site

    Barcelona, 08035
    Spain

    Site Not Available

  • Research Site

    Barcelona 3128760, 08035
    Spain

    Site Not Available

  • Research Site

    Zaragoza, 50009
    Spain

    Site Not Available

  • Research Site

    Zaragoza 3104324, 50009
    Spain

    Site Not Available

  • Research Site

    Kaohsiung City, 833401
    Taiwan

    Site Not Available

  • Research Site

    Kaohsiung City 1673820, 833401
    Taiwan

    Active - Recruiting

  • Research Site

    Taichung, 40705
    Taiwan

    Site Not Available

  • Research Site

    Taichung 1668399, 40705
    Taiwan

    Active - Recruiting

  • Research Site

    Taoyuan, 333
    Taiwan

    Site Not Available

  • Research Site

    Taoyuan District 1667905, 333
    Taiwan

    Site Not Available

  • Research Site

    Birmingham, B9 5SS
    United Kingdom

    Site Not Available

  • Research Site

    Birmingham 2655603, B15 2GW
    United Kingdom

    Site Not Available

  • Research Site

    London, NW3 2QG
    United Kingdom

    Site Not Available

  • Research Site

    London 2643743, NW3 2QG
    United Kingdom

    Site Not Available

  • Research Site

    Birmingham, Alabama 35249
    United States

    Site Not Available

  • Research Site

    Birmingham 4049979, Alabama 4829764 35249
    United States

    Active - Recruiting

  • Research Site

    Scottsdale, Arizona 85259
    United States

    Site Not Available

  • Research Site

    Scottsdale 5313457, Arizona 5551752 85259
    United States

    Site Not Available

  • Research Site

    Los Angeles, California 90095
    United States

    Site Not Available

  • Research Site

    Orange, California 92868
    United States

    Site Not Available

  • Research Site

    Los Angeles 5368361, California 5332921 90095
    United States

    Active - Recruiting

  • Research Site

    Orange 5379513, California 5332921 92868
    United States

    Active - Recruiting

  • Research Site

    Jacksonville, Florida 32224
    United States

    Site Not Available

  • Research Site

    Tampa, Florida 33606
    United States

    Site Not Available

  • Research Site

    Tampa 4174757, Florida 4155751 33606
    United States

    Active - Recruiting

  • Research Site

    Atlanta, Georgia 30309
    United States

    Site Not Available

  • Research Site

    Atlanta 4180439, Georgia 4197000 30309
    United States

    Site Not Available

  • Research Site

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • Research Site

    Kansas City 4273837, Kansas 4273857 66160
    United States

    Site Not Available

  • Research Site

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • Research Site

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Research Site

    Ann Arbor 4984247, Michigan 5001836 48109
    United States

    Site Not Available

  • Research Site

    Detroit 4990729, Michigan 5001836 48202
    United States

    Site Not Available

  • Research Site

    Livingston, New Jersey 07039
    United States

    Site Not Available

  • Research Site

    Livingston 5100572, New Jersey 5101760 07039
    United States

    Active - Recruiting

  • Research Site

    New York, New York 10016
    United States

    Site Not Available

  • Research Site

    Stony Brook, New York 11790
    United States

    Site Not Available

  • Research Site

    New York 5128581, New York 5128638 10016
    United States

    Site Not Available

  • Research Site

    Stony Brook 5139865, New York 5128638 11790
    United States

    Active - Recruiting

  • Research Site

    Durham, North Carolina 27705
    United States

    Site Not Available

  • Research Site

    Durham 4464368, North Carolina 4482348 27705
    United States

    Active - Recruiting

  • Research Site

    Cincinnati, Ohio 45267
    United States

    Site Not Available

  • Research Site

    Cincinnati 4508722, Ohio 5165418 45267
    United States

    Site Not Available

  • Research Site

    Philadelphia, Pennsylvania 19140
    United States

    Site Not Available

  • Research Site

    Philadelphia 4560349, Pennsylvania 6254927 19140
    United States

    Site Not Available

  • Research Site

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Research Site

    Charleston 4574324, South Carolina 4597040 29425
    United States

    Site Not Available

  • Research Site

    Dallas, Texas 75235
    United States

    Site Not Available

  • Research Site

    Houston, Texas 77030
    United States

    Site Not Available

  • Research Site

    Dallas 4684888, Texas 4736286 75235
    United States

    Site Not Available

  • Research Site

    Houston 4699066, Texas 4736286 77030
    United States

    Site Not Available

  • Research Site

    Richmond, Virginia 23298
    United States

    Site Not Available

  • Research Site

    Richmond 4781708, Virginia 6254928 23298
    United States

    Active - Recruiting

  • Research Site

    Seattle, Washington 98195
    United States

    Site Not Available

  • Research Site

    Seattle 5809844, Washington 5815135 98195
    United States

    Site Not Available

  • Research Site

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

  • Research Site

    Milwaukee 5263045, Wisconsin 5279468 53226
    United States

    Site Not Available

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