ALXN2030: ALXN2030 will be administered subcutaneously (SC).
Placebo: Placebo will be administered SC.
Study 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
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Biopsy-proven histologic resolution — Week 52
Trial sites (51)
Facility
City
Region
Status
Research Site
Birmingham
Alabama
Research Site
Scottsdale
Arizona
Research Site
Los Angeles
California
Research Site
Orange
California
Research Site
Tampa
Florida
Research Site
Atlanta
Georgia
Research Site
Kansas City
Kansas
Research Site
Ann Arbor
Michigan
Research Site
Detroit
Michigan
Research Site
Livingston
New Jersey
Research Site
New York
New York
Research Site
New York
New York
Research Site
New York
New York
Research Site
Durham
North Carolina
Research Site
Cincinnati
Ohio
Research Site
Philadelphia
Pennsylvania
Research Site
Dallas
Texas
Research Site
Houston
Texas
Research Site
Richmond
Virginia
Research Site
Seattle
Washington
Research Site
Milwaukee
Wisconsin
Research Site
Botucatu
Brazil
Research Site
Campinas
Brazil
Research Site
Porto Alegre
Brazil
Research Site
São Paulo
Brazil
Research Site
São Paulo
Brazil
Research Site
Calgary
Alberta
Research Site
Edmonton
Alberta
Research Site
Vancouver
British Columbia
Research Site
London
Ontario
Research Site
Toronto
Ontario
Research Site
Changsha
China
Research Site
Guangzhou
China
Research Site
Nanning
China
Research Site
Shanghai
China
Research Site
Wuhan
China
Research Site
Xi'an
China
Research Site
Seoul
South Korea
Research Site
Seoul
South Korea
Research Site
Seoul
South Korea
+ 11 more sites — see the full list on the official registry below.
More Alexion Pharmaceuticals, Inc. trials in the UK
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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