Phase
Condition
Transplant Rejection
Kidney Transplantation
Nephritis
Treatment
Placebo
ALXN2030
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Kidney transplant received ≥ 6 months
Active or chronic active AMR according to Banff 2022 classification, based onScreening kidney biopsy
Either positive C4d on Screening kidney biopsy based on the Central PathologyLaboratory report and/or positive HLA Class I and/or II antigen-specific DSA asdetermined by the local laboratory's definition of positivity using single-antigenbead 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 Bwhere 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
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) orcell transplant (islet, bone marrow, stem cell) recipient
Planned or recent treatments, < 90 days prior to the Screening Visit and duringScreening, for Acute Rejection, AMR (including plasmapheresis, plasma exchange,IVIg, B-cell depleting therapy, IL inhibitors, proteasome inhibitors, high-dosecorticosteroids [except for tapering]), HDS products with known hepatotoxicingredients, TCMR (including T-cell depleting therapy), excluding the SoCimmunosuppressant treatment which will be allowed and should be stable during theentire 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 Design
Study Description
Connect with a study center
Research Site
Botucatu, 18618-687
BrazilSite Not Available
Research Site
Campinas, 13083
BrazilSite Not Available
Research Site
Porto Alegre, 90020-090
BrazilSite Not Available
Research Site
São Paulo, 04038-002
BrazilSite Not Available
Research Site
São Paulo 3448439, 05403-900
BrazilActive - Recruiting
Research Site
Calgary, Alberta T2N 1N4
CanadaSite Not Available
Research Site
Edmonton, Alberta T6G 2R7
CanadaSite Not Available
Research Site
Vancouver, British Columbia V6Z 1Y6
CanadaSite Not Available
Research Site
London, Ontario N6A 5A5
CanadaSite Not Available
Research Site
Toronto, Ontario M5G 2N2
CanadaSite Not Available
Research Site
Changsha, 430033
ChinaSite Not Available
Research Site
Guangzhou, 510080
ChinaSite Not Available
Research Site
Nanning, 530007
ChinaSite Not Available
Research Site
Shanghai, 201114
ChinaSite Not Available
Research Site
Wuhan, 430030
ChinaSite Not Available
Research Site
Xi'an, 710061
ChinaSite Not Available
Research Site
Seoul, 02841
Korea, Republic ofSite Not Available
Research Site
Seoul, 02841
South KoreaSite Not Available
Research Site
Seoul 1835848, 03080
South KoreaActive - Recruiting
Research Site
Barcelona, 8003
SpainSite Not Available
Research Site
Barcelona 3128760, 08035
SpainActive - Recruiting
Research Site
Zaragoza, 50009
SpainSite Not Available
Research Site
Kaohsiung City, 813
TaiwanSite Not Available
Research Site
Kaohsiung City 1673820, 813
TaiwanActive - Recruiting
Research Site
Taichung, 40705
TaiwanSite Not Available
Research Site
Birmingham, B15 2GW
United KingdomSite Not Available
Research Site
Birmingham 2655603, B9 5SS
United KingdomSite Not Available
Research Site
London, NW3 2QG
United KingdomSite Not Available
Research Site
London 2643743, NW3 2QG
United KingdomActive - Recruiting
Research Site
Birmingham, Alabama 35249
United StatesSite Not Available
Research Site
Scottsdale, Arizona 85259
United StatesSite Not Available
Research Site
Los Angeles, California 90095
United StatesSite Not Available
Research Site
Orange, California 92868
United StatesSite Not Available
Research Site
Tampa, Florida 33606
United StatesSite Not Available
Research Site
Atlanta, Georgia 30309
United StatesSite Not Available
Research Site
Kansas City, Kansas 66160
United StatesSite Not Available
Research Site
Ann Arbor, Michigan 48109
United StatesSite Not Available
Research Site
Detroit, Michigan 48202
United StatesSite Not Available
Research Site
Livingston, New Jersey 07039
United StatesSite Not Available
Research Site
New York, New York 10021
United StatesSite Not Available
Research Site
New York 5128581, New York 5128638 10029
United StatesActive - Recruiting
Research Site
Durham, North Carolina 27705
United StatesSite Not Available
Research Site
Cincinnati, Ohio 45267
United StatesSite Not Available
Research Site
Philadelphia, Pennsylvania 19140
United StatesSite Not Available
Research Site
Dallas, Texas 75235
United StatesSite Not Available
Research Site
Houston, Texas 77030
United StatesSite Not Available
Research Site
Richmond, Virginia 23298
United StatesSite Not Available
Research Site
Seattle, Washington 98195
United StatesSite Not Available
Research Site
Milwaukee, Wisconsin 53226
United StatesSite Not Available

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