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

Last updated: May 21, 2025
Sponsor: Alexion Pharmaceuticals, Inc.
Overall Status: Active - Not Recruiting

Phase

2

Condition

Transplant Rejection

Nephritis

Kidney Transplantation

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

  • HLA-DSA (preformed and/or de novo DSA)

  • MVI score ≥ 2 (g ≥ 1 and ptc ≥ 1)

  • eGFR ≥ 30 mL/min/1.73 m2

  • Must be vaccinated for S pneumoniae prior to randomization

  • Must be vaccinated for H influenzae type B (where available) prior to randomization

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 indicating nephrotic range proteinuria

  • Hemoglobin < 8 g/dL

  • Platelets < 100 × 109/L

  • Leucocytes < 3 × 109/L

  • Neutrophils < 1.5 × 109/L

  • Multiorgan transplant recipient (except for previous multiple kidney transplants) orcell transplant (islet, bone marrow, stem cell) recipient

  • Active systemic bacterial, viral, or fungal infection within 14 days prior torandomization

  • Participants with history of HIV who are not on anti-retroviral therapy or if ontherapy have a known detectable viral load within 1 year of Screening

  • Evidence of hepatitis B or hepatitis C infections

  • Congenital immunodeficiency

  • History of unexplained, recurrent infection

  • Pregnant, breastfeeding, or intending to conceive within 6 months after the lastdose of study intervention

  • ALT or AST > 2.0 × ULN

  • Total bilirubin > 2 × ULN (participants with Gilbert's syndrome can be included withtotal bilirubin > 2 × ULN as long as direct bilirubin is ≤ 1.5 × ULN)

  • Current or chronic history of liver disease that is considered clinicallysignificant by the Investigator

  • 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 SoC treatmentwhich will be allowed and should be stable during the entire treatment

Study Design

Total Participants: 45
Treatment Group(s): 2
Primary Treatment: ALXN2030
Phase: 2
Study Start date:
March 07, 2025
Estimated Completion Date:
May 03, 2028

Study Description

This prospective trial will assess the efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of ALXN2030 in kidney transplant recipients with late 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

    Campinas, 13083
    Brazil

    Site Not Available

  • Research Site

    Porto Alegre, 90020-090
    Brazil

    Site Not Available

  • Research Site

    Sao Paulo, 05403-900
    Brazil

    Site Not Available

  • Research Site

    São Paulo, 04038-002
    Brazil

    Site Not Available

  • Research Site

    Edmonton, Alberta T6G 2R7
    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

    Montreal, Quebec H4A 3J1
    Canada

    Site Not Available

  • Research Site

    Changsha, 430033
    China

    Site Not Available

  • Research Site

    Guangzhou, 510080
    China

    Site Not Available

  • Research Site

    Nanning, 530007
    China

    Site Not Available

  • Research Site

    Shanghai, 201114
    China

    Site Not Available

  • Research Site

    Wuhan, 430030
    China

    Site Not Available

  • Research Site

    Xian, 710061
    China

    Site Not Available

  • Research Site

    Seoul, 02841
    Korea, Republic of

    Site Not Available

  • Research Site

    Barcelona, 8003
    Spain

    Site Not Available

  • Research Site

    Zaragoza, 50009
    Spain

    Site Not Available

  • Research Site

    Kaohsiung City, 813
    Taiwan

    Site Not Available

  • Research Site

    Taichung, 40705
    Taiwan

    Site Not Available

  • Research Site

    Taoyuan, 333
    Taiwan

    Site Not Available

  • Research Site

    Birmingham, Alabama 35249
    United States

    Site Not Available

  • Research Site

    Scottsdale, Arizona 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

    Jacksonville, Florida 32224
    United States

    Site Not Available

  • Research Site

    Tampa, Florida 33606
    United States

    Site Not Available

  • Research Site

    Atlanta, Georgia 30309
    United States

    Site Not Available

  • Research Site

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • Research Site

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Research Site

    Livingston, New Jersey 07039
    United States

    Site Not Available

  • Research Site

    New York, New York 10029
    United States

    Site Not Available

  • Research Site

    Stony Brook, New York 11790
    United States

    Site Not Available

  • Research Site

    Durham, North Carolina 27705
    United States

    Site Not Available

  • Research Site

    Cincinnati, Ohio 45267
    United States

    Site Not Available

  • Research Site

    Philadelphia, Pennsylvania 19140
    United States

    Site Not Available

  • Research Site

    Charleston, South Carolina 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

    Richmond, Virginia 23298
    United States

    Site Not Available

  • Research Site

    Seattle, Washington 98195
    United States

    Site Not Available

  • Research Site

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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