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

Status: Recruiting
Location: See all (55) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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

Locations
United States
Alabama
Research Site
RECRUITING
Birmingham
Arizona
Research Site
NOT_YET_RECRUITING
Scottsdale
California
Research Site
RECRUITING
Los Angeles
Research Site
RECRUITING
Orange
Florida
Research Site
RECRUITING
Tampa
Georgia
Research Site
NOT_YET_RECRUITING
Atlanta
Kansas
Research Site
NOT_YET_RECRUITING
Kansas City
Michigan
Research Site
NOT_YET_RECRUITING
Ann Arbor
Research Site
NOT_YET_RECRUITING
Detroit
North Carolina
Research Site
RECRUITING
Durham
New Jersey
Research Site
RECRUITING
Livingston
New York
Research Site
RECRUITING
New York
Research Site
RECRUITING
New York
Research Site
WITHDRAWN
New York
Research Site
NOT_YET_RECRUITING
New York
Ohio
Research Site
NOT_YET_RECRUITING
Cincinnati
Pennsylvania
Research Site
NOT_YET_RECRUITING
Philadelphia
South Carolina
Research Site
WITHDRAWN
Charleston
Texas
Research Site
RECRUITING
Dallas
Research Site
NOT_YET_RECRUITING
Houston
Virginia
Research Site
RECRUITING
Richmond
Washington
Research Site
NOT_YET_RECRUITING
Seattle
Wisconsin
Research Site
RECRUITING
Milwaukee
Other Locations
Brazil
Research Site
NOT_YET_RECRUITING
Botucatu
Research Site
NOT_YET_RECRUITING
Campinas
Research Site
RECRUITING
Porto Alegre
Research Site
RECRUITING
São Paulo
Research Site
RECRUITING
São Paulo
Canada
Research Site
NOT_YET_RECRUITING
Calgary
Research Site
RECRUITING
Edmonton
Research Site
RECRUITING
London
Research Site
WITHDRAWN
Montreal
Research Site
NOT_YET_RECRUITING
Toronto
Research Site
NOT_YET_RECRUITING
Vancouver
China
Research Site
NOT_YET_RECRUITING
Changsha
Research Site
NOT_YET_RECRUITING
Guangzhou
Research Site
NOT_YET_RECRUITING
Nanning
Research Site
NOT_YET_RECRUITING
Shanghai
Research Site
NOT_YET_RECRUITING
Wuhan
Research Site
NOT_YET_RECRUITING
Xi'an
Republic of Korea
Research Site
RECRUITING
Seoul
Research Site
RECRUITING
Seoul
Research Site
RECRUITING
Seoul
Research Site
RECRUITING
Seoul
Research Site
RECRUITING
Seoul
Spain
Research Site
NOT_YET_RECRUITING
Barcelona
Research Site
NOT_YET_RECRUITING
Barcelona
Research Site
NOT_YET_RECRUITING
Zaragoza
Taiwan
Research Site
RECRUITING
Kaohsiung City
Research Site
RECRUITING
Kaohsiung City
Research Site
RECRUITING
Taichung
Research Site
WITHDRAWN
Taoyuan District
United Kingdom
Research Site
NOT_YET_RECRUITING
Birmingham
Research Site
NOT_YET_RECRUITING
London
Research Site
NOT_YET_RECRUITING
London
Contact Information
Primary
Alexion Pharmaceuticals, Inc. (Sponsor)
clinicaltrials@alexion.com
1-855-752-2356
Time Frame
Start Date: 2025-03-07
Estimated Completion Date: 2028-11-07
Participants
Target number of participants: 45
Treatments
Placebo_comparator: Placebo
Placebo will be administered during the Double-Blind Treatment Period of 52 weeks.
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).
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.
Related Therapeutic Areas
Sponsors
Leads: Alexion Pharmaceuticals, Inc.

This content was sourced from clinicaltrials.gov