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

August 10, 2026 updated by: Alexion Pharmaceuticals, Inc.

A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate Efficacy and Safety of ALXN2030 in Adult Patients With Antibody-Mediated Rejection After Kidney Transplantation

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
47

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Brazil
      • Botucatu, Brazil, 18618-687
        • Research Site
      • Campinas, Brazil, 13083
        • Research Site
      • Porto Alegre, Brazil, 90020-090
        • Research Site
      • São Paulo, Brazil, 05403-900
        • Research Site
      • São Paulo, Brazil, 04038-002
        • Research Site
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 1N4
        • Research Site
      • Edmonton, Alberta, Canada, T6G 2R7
        • Research Site
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • Research Site
    • Ontario
      • London, Ontario, Canada, N6A 5A5
        • Research Site
      • Toronto, Ontario, Canada, M5G 2N2
        • Research Site
  • China
      • Changsha, China, 430033
        • Research Site
      • Guangzhou, China, 510080
        • Research Site
      • Nanning, China, 530007
        • Research Site
      • Shanghai, China, 201114
        • Research Site
      • Wuhan, China, 430030
        • Research Site
      • Xi'an, China, 710061
        • Research Site
  • South Korea
      • Seoul, South Korea, 02841
        • Research Site
      • Seoul, South Korea, 03080
        • Research Site
      • Seoul, South Korea, 06351
        • Research Site
      • Seoul, South Korea, 06591
        • Research Site
      • Seoul, South Korea, 3722
        • Research Site
  • Spain
      • Barcelona, Spain, 08035
        • Research Site
      • Barcelona, Spain, 8003
        • Research Site
      • Zaragoza, Spain, 50009
        • Research Site
  • Taiwan
      • Kaohsiung City, Taiwan, 833401
        • Research Site
      • Kaohsiung City, Taiwan, 813
        • Research Site
      • Taichung, Taiwan, 40705
        • Research Site
  • United Kingdom
      • Birmingham, United Kingdom, B15 2GW
        • Research Site
      • London, United Kingdom, NW3 2QG
        • Research Site
      • London, United Kingdom, W12 0HS
        • Research Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35249
        • Research Site
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Research Site
    • California
      • Los Angeles, California, United States, 90095
        • Research Site
      • Orange, California, United States, 92868
        • Research Site
    • Florida
      • Tampa, Florida, United States, 33606
        • Research Site
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Research Site
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Research Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Research Site
      • Detroit, Michigan, United States, 48202
        • Research Site
    • New Jersey
      • Livingston, New Jersey, United States, 07039
        • Research Site
    • New York
      • New York, New York, United States, 10021
        • Research Site
      • New York, New York, United States, 10032
        • Research Site
      • New York, New York, United States, 10029
        • Research Site
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Research Site
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • Research Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Research Site
    • Texas
      • Dallas, Texas, United States, 75235
        • Research Site
      • Houston, Texas, United States, 77030
        • Research Site
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Research Site
    • Washington
      • Seattle, Washington, United States, 98195
        • Research Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Placebo will be administered during the Double-Blind Treatment Period of 52 weeks.
Drug: Placebo
Placebo will be administered SC.
Experimental: 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).
Drug: ALXN2030
ALXN2030 will be administered subcutaneously (SC).
Experimental: 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.
Drug: ALXN2030
ALXN2030 will be administered subcutaneously (SC).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Biopsy-proven histologic resolution
Time Frame: Week 52
Week 52

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Biopsy-proven histologic resolution
Time Frame: Week 28
Week 28
Change From Baseline in biopsy-proven histologic scores
Time Frame: Baseline, Weeks 28 and 52
Baseline, Weeks 28 and 52
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 52
Time Frame: Baseline up to week 52
Baseline up to week 52
Annualized Total eGFR Slope
Time Frame: Baseline up to Week 52
Baseline up to Week 52
Stabilized eGFR
Time Frame: Baseline up to Week 52
Baseline up to Week 52
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs)
Time Frame: Day 1 up to Week 104
Day 1 up to Week 104
Number of Participants With Anti-drug Antibodies (ADAs)
Time Frame: Day 1 through Week 104
Day 1 through Week 104
Plasma Concentration of ALXN2030
Time Frame: Baseline up to Week 104
Baseline up to Week 104
Plasma Concentration of C3 Protein
Time Frame: Baseline up to Week 104
Baseline up to Week 104
Change From Baseline in Serum Complement Functional Activity
Time Frame: Baseline, up to Week 52 and up to Week 104
Baseline, up to Week 52 and up to Week 104

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Alexion Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 7, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 11, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 7, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 13, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 18, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 20, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D8560C00002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Alexion has a public commitment to allow requests for access to study data and will be supplying a protocol, CSR, and plain language summaries.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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