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

NCT06744647 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: D8560C00002
• Study Type: interventional
• Target: 45
• Locations: 8 countries
• Sites: 55

Brief 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.

Conditions

Biopsy-proven Histologic Scores; AMR; Antibody-Mediated Rejection; Kidney Transplantation

Keywords

ALXN2030; Antibody-Mediated Rejection; Kidney Transplantation; Biopsy-proven histologic scores; AMR

Outcome Measures

Primary Outcomes (1)

• Biopsy-proven histologic resolution

  Week 52

Secondary Outcomes (10)

• Biopsy-proven histologic resolution

  Week 28

• Change From Baseline in biopsy-proven histologic scores

  Baseline, Weeks 28 and 52

• Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 52

  Baseline up to week 52

• Annualized Total eGFR Slope

  Baseline up to Week 52

• Stabilized eGFR

  Baseline up to Week 52

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Placebo will be administered during the Double-Blind Treatment Period of 52 weeks.

Drug: Placebo

ALXN2030 Dose A

EXPERIMENTAL

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 Dose B

EXPERIMENTAL

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

Interventions

ALXN2030 DRUG

ALXN2030 will be administered subcutaneously (SC).

ALXN2030 Dose A; ALXN2030 Dose B

Placebo DRUG

Placebo will be administered SC.

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Alexion Pharmaceuticals, Inc.: lead

Study Sites (55)

Research Site

Birmingham, Alabama, 35249, United States

RECRUITING

Research Site

Scottsdale, Arizona, 85259, United States

RECRUITING

Research Site

Los Angeles, California, 90095, United States

RECRUITING

Research Site

Orange, California, 92868, United States

RECRUITING

Research Site

Tampa, Florida, 33606, United States

RECRUITING

Research Site

Atlanta, Georgia, 30309, United States

RECRUITING

Research Site

Kansas City, Kansas, 66160, United States

RECRUITING

Research Site

Ann Arbor, Michigan, 48109, United States

RECRUITING

Research Site

Detroit, Michigan, 48202, United States

RECRUITING

Research Site

Livingston, New Jersey, 07039, United States

RECRUITING

Research Site

New York, New York, 10016, United States

WITHDRAWN

Research Site

New York, New York, 10021, United States

RECRUITING

Research Site

New York, New York, 10029, United States

RECRUITING

Research Site

New York, New York, 10032, United States

RECRUITING

Research Site

Durham, North Carolina, 27705, United States

RECRUITING

Research Site

Cincinnati, Ohio, 45267, United States

NOT YET RECRUITING

Research Site

Philadelphia, Pennsylvania, 19140, United States

NOT YET RECRUITING

Research Site

Charleston, South Carolina, 29425, United States

WITHDRAWN

Research Site

Dallas, Texas, 75235, United States

RECRUITING

Research Site

Houston, Texas, 77030, United States

RECRUITING

Research Site

Richmond, Virginia, 23298, United States

RECRUITING

Research Site

Seattle, Washington, 98195, United States

RECRUITING

Research Site

Milwaukee, Wisconsin, 53226, United States

RECRUITING

Research Site

Botucatu, 18618-687, Brazil

RECRUITING

Research Site

Campinas, 13083, Brazil

RECRUITING

Research Site

Porto Alegre, 90020-090, Brazil

RECRUITING

Research Site

São Paulo, 04038-002, Brazil

RECRUITING

Research Site

São Paulo, 05403-900, Brazil

RECRUITING

Research Site

Calgary, Alberta, T2N 1N4, Canada

NOT YET RECRUITING

Research Site

Edmonton, Alberta, T6G 2R7, Canada

RECRUITING

Research Site

Vancouver, British Columbia, V6Z 1Y6, Canada

RECRUITING

Research Site

London, Ontario, N6A 5A5, Canada

RECRUITING

Research Site

Toronto, Ontario, M5G 2N2, Canada

NOT YET RECRUITING

Research Site

Montreal, Quebec, H4A 3J1, Canada

WITHDRAWN

Research Site

Changsha, 430033, China

RECRUITING

Research Site

Guangzhou, 510080, China

RECRUITING

Research Site

Nanning, 530007, China

RECRUITING

Research Site

Shanghai, 201114, China

RECRUITING

Research Site

Wuhan, 430030, China

RECRUITING

Research Site

Xi'an, 710061, China

RECRUITING

Research Site

Seoul, 02841, South Korea

RECRUITING

Research Site

Seoul, 03080, South Korea

RECRUITING

Research Site

Seoul, 06351, South Korea

RECRUITING

Research Site

Seoul, 06591, South Korea

RECRUITING

Research Site

Seoul, 3722, South Korea

RECRUITING

Research Site

Barcelona, 08035, Spain

RECRUITING

Research Site

Barcelona, 8003, Spain

RECRUITING

Research Site

Zaragoza, 50009, Spain

RECRUITING

Research Site

Kaohsiung City, 813, Taiwan

RECRUITING

Research Site

Kaohsiung City, 833401, Taiwan

RECRUITING

Research Site

Taichung, 40705, Taiwan

RECRUITING

Research Site

Taoyuan District, 333, Taiwan

WITHDRAWN

Research Site

Birmingham, B15 2GW, United Kingdom

RECRUITING

Research Site

London, NW3 2QG, United Kingdom

RECRUITING

Research Site

London, W12 0HS, United Kingdom

RECRUITING

Central Study Contacts

Alexion Pharmaceuticals, Inc. (Sponsor)

CONTACT

1-855-752-2356; clinicaltrials@alexion.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2024
• First Posted: December 20, 2024
• Study Start: March 7, 2025
• Primary Completion (Estimated): October 11, 2027
• Study Completion (Estimated): November 7, 2028
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

BR (5); GB (3); US (23); KR (5); CN (6); CA (6); TW (4); ES (3)