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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Antibody-Mediated Rejection, Kidney Transplantation, Biopsy-proven Histologic Scores, AMR

In brief

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.

Key facts

Study ID

NCT06744647

Run by

Alexion Pharmaceuticals, Inc.

People needed

45

Starts

2025-03-07

Expected to finish

2028-11-07

Last updated by the study team

2026-06-18

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 it is running

• Research Site — São Paulo, Brazil (enrolling)
• Research Site — Los Angeles, California, United States (enrolling)
• Research Site — São Paulo, Brazil (enrolling)
• Research Site — Scottsdale, Arizona, United States (enrolling)
• Research Site — Atlanta, Georgia, United States (enrolling)
• Research Site — Kansas City, Kansas, United States (enrolling)
• Research Site — Birmingham, Alabama, United States (enrolling)
• Research Site — Porto Alegre, Brazil (enrolling)
• Research Site — Livingston, New Jersey, United States (enrolling)
• Research Site — Tampa, Florida, United States (enrolling)
• Research Site — New York, New York, United States (enrolling)
• Research Site — New York, New York, United States (enrolling)
• Research Site — New York, New York, United States (enrolling)
• Research Site — Durham, North Carolina, United States (enrolling)
• Research Site — Ann Arbor, Michigan, United States (enrolling)
• Research Site — Orange, California, United States (enrolling)
• Research Site — Detroit, Michigan, United States (enrolling)
• Research Site — Dallas, Texas, United States (enrolling)
• Research Site — Houston, Texas, United States (enrolling)
• Research Site — Richmond, Virginia, United States (enrolling)
• Research Site — Seattle, Washington, United States (enrolling)
• Research Site — Milwaukee, Wisconsin, United States (enrolling)
• Research Site — Botucatu, Brazil (enrolling)
• Research Site — Campinas, Brazil (enrolling)
• Research Site — Calgary, Alberta, Canada (enrolling)

Full record on ClinicalTrials.gov

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