Phase
Condition
Transplant Rejection
Nephritis
Kidney Transplantation
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
HLA-DSA (preformed and/or de novo DSA)
MVI score ≥ 2 (g ≥ 1 and ptc ≥ 1)
eGFR ≥ 30 mL/min/1.73 m2
Must be vaccinated for S pneumoniae prior to randomization
Must be vaccinated for H influenzae type B (where available) prior to randomization
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 indicating nephrotic range proteinuria
Hemoglobin < 8 g/dL
Platelets < 100 × 109/L
Leucocytes < 3 × 109/L
Neutrophils < 1.5 × 109/L
Multiorgan transplant recipient (except for previous multiple kidney transplants) orcell transplant (islet, bone marrow, stem cell) recipient
Active systemic bacterial, viral, or fungal infection within 14 days prior torandomization
Participants with history of HIV who are not on anti-retroviral therapy or if ontherapy have a known detectable viral load within 1 year of Screening
Evidence of hepatitis B or hepatitis C infections
Congenital immunodeficiency
History of unexplained, recurrent infection
Pregnant, breastfeeding, or intending to conceive within 6 months after the lastdose of study intervention
ALT or AST > 2.0 × ULN
Total bilirubin > 2 × ULN (participants with Gilbert's syndrome can be included withtotal bilirubin > 2 × ULN as long as direct bilirubin is ≤ 1.5 × ULN)
Current or chronic history of liver disease that is considered clinicallysignificant by the Investigator
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 SoC treatmentwhich will be allowed and should be stable during the entire treatment
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
Sao Paulo, 05403-900
BrazilSite Not Available
Research Site
São Paulo, 04038-002
BrazilSite Not Available
Research Site
Edmonton, Alberta T6G 2R7
CanadaSite Not Available
Research Site
London, Ontario N6A 5A5
CanadaSite Not Available
Research Site
Toronto, Ontario M5G 2N2
CanadaSite Not Available
Research Site
Montreal, Quebec H4A 3J1
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
Xian, 710061
ChinaSite Not Available
Research Site
Seoul, 02841
Korea, Republic ofSite Not Available
Research Site
Barcelona, 8003
SpainSite Not Available
Research Site
Zaragoza, 50009
SpainSite Not Available
Research Site
Kaohsiung City, 813
TaiwanSite Not Available
Research Site
Taichung, 40705
TaiwanSite Not Available
Research Site
Taoyuan, 333
TaiwanSite Not Available
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
Jacksonville, Florida 32224
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
Detroit, Michigan 48202
United StatesSite Not Available
Research Site
Livingston, New Jersey 07039
United StatesSite Not Available
Research Site
New York, New York 10029
United StatesSite Not Available
Research Site
Stony Brook, New York 11790
United StatesSite Not Available
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
Charleston, South Carolina 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
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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