Phase
Condition
Kidney Transplantation
Transplant Rejection
Nephritis
Treatment
ALXN2030
Placebo
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, < 3 months prior to the Screening Visit, for AcuteRejection, AMR (including plasmapheresis, plasma exchange, IVIg, B-cell depletingtherapy, IL inhibitors, proteasome inhibitors, high-dose corticosteroids [except fortapering]), TCMR (including T-cell depleting therapy), excluding the SoCimmunosuppressant treatment which will be allowed and should be stable during theentire treatment.
Study Design
Study Description
Connect with a study center
Research Site
Botucatu, 18618-687
BrazilSite Not Available
Research Site
Botucatu 3469136, 18618-687
BrazilSite Not Available
Research Site
Campinas, 13083
BrazilSite Not Available
Research Site
Campinas 3467865, 13083
BrazilSite Not Available
Research Site
Porto Alegre, 90020-090
BrazilSite Not Available
Research Site
Porto Alegre 3452925, 90020-090
BrazilActive - Recruiting
Research Site
Sao Paulo, 05403-900
BrazilSite Not Available
Research Site
São Paulo, 04038-002
BrazilSite Not Available
Research Site
São Paulo 3448439, 04038-002
BrazilSite Not Available
Research Site
Edmonton, Alberta T6G 2R7
CanadaSite Not Available
Research Site
Calgary 5913490, Alberta 5883102 T2N 1N4
CanadaSite Not Available
Research Site
Edmonton 5946768, Alberta 5883102 T6G 2R7
CanadaActive - Recruiting
Research Site
Vancouver 6173331, British Columbia 5909050 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
London 6058560, Ontario 6093943 N6A 5A5
CanadaActive - Recruiting
Research Site
Toronto 6167865, Ontario 6093943 M5G 2N2
CanadaSite Not Available
Research Site
Montreal, Quebec H4A 3J1
CanadaSite Not Available
Research Site
Montreal 6077243, Quebec 6115047 H4A 3J1
CanadaSite Not Available
Research Site
Changsha, 430033
ChinaSite Not Available
Research Site
Changsha 1815577, 430033
ChinaSite Not Available
Research Site
Guangzhou, 510080
ChinaSite Not Available
Research Site
Guangzhou 1809858, 510080
ChinaSite Not Available
Research Site
Nanning, 530007
ChinaSite Not Available
Research Site
Nanning 1799869, 530007
ChinaSite Not Available
Research Site
Shanghai, 201114
ChinaSite Not Available
Research Site
Shanghai 1796236, 201114
ChinaSite Not Available
Research Site
Wuhan, 430030
ChinaSite Not Available
Research Site
Wuhan 1791247, 430030
ChinaSite Not Available
Research Site
Xi'an 1790630, 710061
ChinaSite Not Available
Research Site
Xian, 710061
ChinaSite Not Available
Research Site
Seoul, 06591
Korea, Republic ofSite Not Available
Research Site
Seoul 1835848, 06351
South KoreaActive - Recruiting
Research Site
Barcelona, 08035
SpainSite Not Available
Research Site
Barcelona 3128760, 08035
SpainSite Not Available
Research Site
Zaragoza, 50009
SpainSite Not Available
Research Site
Zaragoza 3104324, 50009
SpainSite Not Available
Research Site
Kaohsiung City, 833401
TaiwanSite Not Available
Research Site
Kaohsiung City 1673820, 833401
TaiwanActive - Recruiting
Research Site
Taichung, 40705
TaiwanSite Not Available
Research Site
Taichung 1668399, 40705
TaiwanActive - Recruiting
Research Site
Taoyuan, 333
TaiwanSite Not Available
Research Site
Taoyuan District 1667905, 333
TaiwanSite Not Available
Research Site
Birmingham, B9 5SS
United KingdomSite Not Available
Research Site
Birmingham 2655603, B15 2GW
United KingdomSite Not Available
Research Site
London, NW3 2QG
United KingdomSite Not Available
Research Site
London 2643743, NW3 2QG
United KingdomSite Not Available
Research Site
Birmingham, Alabama 35249
United StatesSite Not Available
Research Site
Birmingham 4049979, Alabama 4829764 35249
United StatesActive - Recruiting
Research Site
Scottsdale, Arizona 85259
United StatesSite Not Available
Research Site
Scottsdale 5313457, Arizona 5551752 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
Los Angeles 5368361, California 5332921 90095
United StatesActive - Recruiting
Research Site
Orange 5379513, California 5332921 92868
United StatesActive - Recruiting
Research Site
Jacksonville, Florida 32224
United StatesSite Not Available
Research Site
Tampa, Florida 33606
United StatesSite Not Available
Research Site
Tampa 4174757, Florida 4155751 33606
United StatesActive - Recruiting
Research Site
Atlanta, Georgia 30309
United StatesSite Not Available
Research Site
Atlanta 4180439, Georgia 4197000 30309
United StatesSite Not Available
Research Site
Kansas City, Kansas 66160
United StatesSite Not Available
Research Site
Kansas City 4273837, Kansas 4273857 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
Ann Arbor 4984247, Michigan 5001836 48109
United StatesSite Not Available
Research Site
Detroit 4990729, Michigan 5001836 48202
United StatesSite Not Available
Research Site
Livingston, New Jersey 07039
United StatesSite Not Available
Research Site
Livingston 5100572, New Jersey 5101760 07039
United StatesActive - Recruiting
Research Site
New York, New York 10016
United StatesSite Not Available
Research Site
Stony Brook, New York 11790
United StatesSite Not Available
Research Site
New York 5128581, New York 5128638 10016
United StatesSite Not Available
Research Site
Stony Brook 5139865, New York 5128638 11790
United StatesActive - Recruiting
Research Site
Durham, North Carolina 27705
United StatesSite Not Available
Research Site
Durham 4464368, North Carolina 4482348 27705
United StatesActive - Recruiting
Research Site
Cincinnati, Ohio 45267
United StatesSite Not Available
Research Site
Cincinnati 4508722, Ohio 5165418 45267
United StatesSite Not Available
Research Site
Philadelphia, Pennsylvania 19140
United StatesSite Not Available
Research Site
Philadelphia 4560349, Pennsylvania 6254927 19140
United StatesSite Not Available
Research Site
Charleston, South Carolina 29425
United StatesSite Not Available
Research Site
Charleston 4574324, South Carolina 4597040 29425
United StatesSite Not Available
Research Site
Dallas, Texas 75235
United StatesSite Not Available
Research Site
Houston, Texas 77030
United StatesSite Not Available
Research Site
Dallas 4684888, Texas 4736286 75235
United StatesSite Not Available
Research Site
Houston 4699066, Texas 4736286 77030
United StatesSite Not Available
Research Site
Richmond, Virginia 23298
United StatesSite Not Available
Research Site
Richmond 4781708, Virginia 6254928 23298
United StatesActive - Recruiting
Research Site
Seattle, Washington 98195
United StatesSite Not Available
Research Site
Seattle 5809844, Washington 5815135 98195
United StatesSite Not Available
Research Site
Milwaukee, Wisconsin 53226
United StatesSite Not Available
Research Site
Milwaukee 5263045, Wisconsin 5279468 53226
United StatesSite Not Available
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