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 (> 50 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.
- All participants must receive prophylactic treatment with appropriate antibioticswhile receiving Rituximab (RTX), and be willing to be vaccinated against Neisseriameningitidis
Exclusion
Exclusion Criteria:
Estimated glomerular filtration rate (GFR) < 60 mL/min/1.73 m^2 during Screening
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 < 50 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
Use of SGLT2i, MRA, or ERA within 8 weeks prior to randomization and throughout thestudy period
Note: Additional inclusion/exclusion criteria may apply, per protocol.
Study Design
Connect with a study center
Research Site
Buenos Aires 3435910, 1425
ArgentinaSite Not Available
Research Site
CABA, C1425AGC
ArgentinaSite Not Available
Research Site
Ciudad de Buenos Aires, 1280
ArgentinaSite Not Available
Research Site
Rosario 3838583, 2000
ArgentinaSite Not Available
Research Site
Santa Fe 3836277, S3000EOZ
ArgentinaSite Not Available
Research Site
Gosford 2164849, 2250
AustraliaSite Not Available
Research Site
Parkville 2153770, 3050
AustraliaSite Not Available
Research Site
Southport 2148928, 4222
AustraliaActive - Recruiting
Research Site
Recife 3390760, 50670-901
BrazilSite Not Available
Research Site
Salvador 3450554, 40301-155
BrazilSite Not Available
Research Site
São Paulo 3448439, 05403-000
BrazilSite Not Available
Research Site
Baotou 2038432, 014010
ChinaSite Not Available
Research Site
Beijing 1816670, 100034
ChinaSite Not Available
Research Site
Guangzhou 1809858, 510080
ChinaSite Not Available
Research Site
Shenzhen 1795565, 518036
ChinaSite Not Available
Research Site
Créteil 3022530, 94010
FranceSite Not Available
Research Site
Nice 2990440, 06000
FranceSite Not Available
Research Site
Toulouse 2972315, 31059
FranceSite Not Available
Research Site
Milan 6951411, 20122
ItalySite Not Available
Research Site
Ranica 6535785, 24020
ItalySite Not Available
Research Site
Torrette 8960841, 60126
ItalySite Not Available
Research Site
Barcelona 3128760, 08025
SpainSite Not Available
Research Site
Madrid 3117735, 28007
SpainSite Not Available
Research Site
Seville 2510911, 41013
SpainSite Not Available
Research Site
Toledo 2510409, 45007
SpainSite Not Available
Research Site
Kaohsiung City 1673820, 81362
TaiwanSite Not Available
Research Site
Taichung 1668399, 40705
TaiwanActive - Recruiting
Research Site
Taoyuan District 1667905, 333
TaiwanSite Not Available
Research Site
Cambridge 2653941, CB2 0XY
United KingdomSite Not Available
Research Site
Leicester 2644668, LE1 5WW
United KingdomSite Not Available
Research Site
London 2643743, SE5 9RJ
United KingdomSite Not Available
Research Site
Salford 2638671, M6 8HD
United KingdomSite Not Available
Research Site
Loma Linda 5367696, California 5332921 92354
United StatesSite Not Available
Research Site
San Diego 5391811, California 5332921 92123
United StatesSite Not Available
Research Site
Minneapolis 5037649, Minnesota 5037779 55435
United StatesSite Not Available
Research Site
Rochester 5043473, Minnesota 5037779 55905
United StatesSite Not Available
Research Site
Houston 4699066, Texas 4736286 77030
United StatesSite Not Available
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