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New hope for kidney transplant patients facing rejection

NCT ID NCT06744647

Disease control Sponsor: Alexion Pharmaceuticals, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 12, 2026 · Updated 2 times

Summary

This study tests a new drug called ALXN2030 in 45 adults who have had a kidney transplant and are experiencing antibody-mediated rejection (AMR). The goal is to see if the drug can help resolve signs of rejection seen on a kidney biopsy after one year of treatment. Participants will receive either ALXN2030 or a placebo, and their kidney function and safety will be monitored.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

47 people

The number who actually took part.

Started

Mar 2025

Expected to finish

Nov 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

acute transplant rejection

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

AMR Antibody-mediated rejection Biopsy-proven histologic scores Kidney transplantation

Contacts and locations

Locations

  • Research Site

    Birmingham, Alabama, 35249, United States

  • Research Site

    Scottsdale, Arizona, 85259, United States

  • Research Site

    Los Angeles, California, 90095, United States

  • Research Site

    Orange, California, 92868, United States

  • Research Site

    Tampa, Florida, 33606, United States

  • Research Site

    Atlanta, Georgia, 30309, United States

  • Research Site

    Kansas City, Kansas, 66160, United States

  • Research Site

    Ann Arbor, Michigan, 48109, United States

  • Research Site

    Detroit, Michigan, 48202, United States

  • Research Site

    Livingston, New Jersey, 07039, United States

  • Research Site

    New York, New York, 10021, United States

  • Research Site

    New York, New York, 10029, United States

  • Research Site

    New York, New York, 10032, United States

  • Research Site

    Durham, North Carolina, 27705, United States

  • Research Site

    Cincinnati, Ohio, 45267, United States

  • Research Site

    Philadelphia, Pennsylvania, 19140, United States

  • Research Site

    Dallas, Texas, 75235, United States

  • Research Site

    Houston, Texas, 77030, United States

  • Research Site

    Richmond, Virginia, 23298, United States

  • Research Site

    Seattle, Washington, 98195, United States

  • Research Site

    Milwaukee, Wisconsin, 53226, United States

  • Research Site

    Botucatu, 18618-687, Brazil

  • Research Site

    Campinas, 13083, Brazil

  • Research Site

    Porto Alegre, 90020-090, Brazil

  • Research Site

    São Paulo, 04038-002, Brazil

  • Research Site

    São Paulo, 05403-900, Brazil

  • Research Site

    Calgary, Alberta, T2N 1N4, Canada

  • Research Site

    Edmonton, Alberta, T6G 2R7, Canada

  • Research Site

    Vancouver, British Columbia, V6Z 1Y6, Canada

  • Research Site

    London, Ontario, N6A 5A5, Canada

  • Research Site

    Toronto, Ontario, M5G 2N2, Canada

  • Research Site

    Changsha, 430033, China

  • Research Site

    Guangzhou, 510080, China

  • Research Site

    Nanning, 530007, China

  • Research Site

    Shanghai, 201114, China

  • Research Site

    Wuhan, 430030, China

  • Research Site

    Xi'an, 710061, China

  • Research Site

    Seoul, 02841, South Korea

  • Research Site

    Seoul, 03080, South Korea

  • Research Site

    Seoul, 06351, South Korea

  • Research Site

    Seoul, 06591, South Korea

  • Research Site

    Seoul, 3722, South Korea

  • Research Site

    Barcelona, 08035, Spain

  • Research Site

    Barcelona, 8003, Spain

  • Research Site

    Zaragoza, 50009, Spain

  • Research Site

    Kaohsiung City, 813, Taiwan

  • Research Site

    Kaohsiung City, 833401, Taiwan

  • Research Site

    Taichung, 40705, Taiwan

  • Research Site

    Birmingham, B15 2GW, United Kingdom

  • Research Site

    London, NW3 2QG, United Kingdom

  • Research Site

    London, W12 0HS, United Kingdom

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