Phase
Condition
Idiopathic Membranous Nephropathy
Treatment
ALXN1920
Placebo
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participants who have a documented diagnosis of PMN, established by positiveantiPLA2R antibody level (> 20 RU/mL) at Screening, which must be confirmed by acentral laboratory
Participants are willing to receive the background Standard of Care (SoC)
Participants at high risk for disease progression, defined as:
Receiving ACE inhibitor or ARB for a minimum of 8 weeks prior to Screening,with the dose titrated to the maximally tolerated level. Participants with lessthan 8 weeks on ACE inhibitor or ARB before Screening or who have not yetreached maximally tolerated dose will enter the Run-in Period.
Participants who are on ACE inhibitor or ARB for a minimum of 8 weeks withSystolic Blood Pressure < 140 mmHg in ≥ 75% of the readings within last 8weeks.
Having two proteinuria measurements with each > 3.5 g/day, the secondmeasurement showing ≤50% decrease from the first measurement.
eGFR60 mL/min/1.73 m2 during Screening calculated by CKD-EPI 2021 creatinine formula
All participants must receive prophylactic treatment with appropriate antibioticswhile receiving Rituximab (RTX), and be willing to be vaccinated against Neisseriameningitidis
Exclusion
Exclusion Criteria:
Documented rapid deterioration of kidney function
History of life-threatening Nephrotic Syndrome within 1 year before Screening
Diagnosis of anti- phospholipase A2 receptor (PLA2R) negative membranous nephropathy (MN) or anti-PLA2R positive MN but Screening serum anti-PLA2R < 20 RU/mL or kidneydisease other than PMN
History of kidney transplant or planned kidney transplant or dialysis during theTreatment Period
History of other solid organ (heart, lung, small bowel, pancreas, or liver) or bonemarrow transplant; or planned transplant during the Treatment Period
History or presence of any clinically relevant co-morbidities
History of intolerance or hypersensitivity to ACEi or ARB
Initiation or dose adjustment of SGLT2i within 12 weeks prior to randomization orplanned adjustment of GSLT2i dose throughout the treatment period.
Use of traditional Chinese medicines or Chinese proprietary medicines with systemicimmunosuppressive properties within 6 months prior to screening.
Use of MRA, or ERA within 12 weeks prior to randomization and throughout the studyperiod
Note: Additional inclusion/exclusion criteria may apply, per protocol.
Study Design
Connect with a study center
Research Site
Buenos Aires, 1425
ArgentinaActive - Recruiting
Research Site
CABA, C1425HFA
ArgentinaActive - Recruiting
Research Site
Ciudad de Buenos Aires, 1280
ArgentinaActive - Recruiting
Research Site
La Plata, B1902COS
ArgentinaSite Not Available
Research Site
Rosario, 2000
ArgentinaActive - Recruiting
Research Site
Santa Fe, S3000
ArgentinaSite Not Available
Research Site
Santa Fe 3836277, S3000EOZ
ArgentinaSite Not Available
Research Site
Gosford, 2250
AustraliaSite Not Available
Research Site
Parkville, 3050
AustraliaActive - Recruiting
Research Site
Southport, 4222
AustraliaActive - Recruiting
Research Site
Recife, 50670-901
BrazilActive - Recruiting
Research Site
Salvador, 40301-155
BrazilActive - Recruiting
Research Site
São Paulo, 04038-002
BrazilActive - Recruiting
Research Site
São Paulo 3448439, 04038-002
BrazilActive - Recruiting
Research Site
Baotou, 014010
ChinaActive - Recruiting
Research Site
Beijing, 100034
ChinaActive - Recruiting
Research Site
Guangzhou, 510080
ChinaActive - Recruiting
Research Site
Guangzhou 1809858, 510100
ChinaSite Not Available
Research Site
Shenzhen, 518036
ChinaActive - Recruiting
Research Site
Créteil, 94010
FranceSite Not Available
Research Site
Nice, 06000
FranceActive - Recruiting
Research Site
Toulouse, 31059
FranceActive - Recruiting
Research Site
Milan, 20122
ItalyActive - Recruiting
Research Site
Milan 6951411, 20156
ItalySite Not Available
Research Site
Ranica, 24020
ItalyActive - Recruiting
Research Site
Torrette, 60126
ItalyActive - Recruiting
Research Site
Barcelona, 08025
SpainActive - Recruiting
Research Site
Madrid, 28007
SpainActive - Recruiting
Research Site
Seville, 41013
SpainActive - Recruiting
Research Site
Toledo, 45007
SpainActive - Recruiting
Research Site
Kaohsiung City, 81362
TaiwanActive - Recruiting
Research Site
Taichung, 40705
TaiwanActive - Recruiting
Research Site
Taoyuan, 333
TaiwanActive - Recruiting
Research Site
Cambridge, CB2 0QQ
United KingdomActive - Recruiting
Research Site
Cambridge 2653941, CB2 0XY
United KingdomSite Not Available
Research Site
Leicester, LE5 4PW
United KingdomActive - Recruiting
Research Site
Leicester 2644668, LE1 5WW
United KingdomSite Not Available
Research Site
London, SE5 9RJ
United KingdomActive - Recruiting
Research Site
Salford, M6 8HD
United KingdomActive - Recruiting
Research Site
Loma Linda, California 92354
United StatesActive - Recruiting
Research Site
San Diego, California 92123
United StatesActive - Recruiting
Research Site
Minneapolis, Minnesota 55435
United StatesActive - Recruiting
Research Site
Rochester, Minnesota 55905
United StatesActive - Recruiting
Research Site
Houston, Texas 77030
United StatesActive - Recruiting

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