Study of ALXN1920 in Adult Participants With Primary Membranous Nephropathy (PMN)
NCT ID: NCT07157787
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
30 participants
INTERVENTIONAL
2025-09-19
2027-02-12
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ALXN1920
Participants will receive ALXN1920 subcutaneous (SC) and background treatment of ACE/ARB and Rituximab.
ALXN1920
Participants will receive ALXN1920 SC infusion.
Placebo
Participants will receive placebo subcutaneous (SC) and background treatment of ACE/ARB and Rituximab.
Placebo
Participants will receive Placebo SC infusion.
Interventions
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ALXN1920
Participants will receive ALXN1920 SC infusion.
Placebo
Participants will receive Placebo SC infusion.
Eligibility Criteria
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Inclusion Criteria
* Participants are willing to receive the background Standard of Care (SoC)
* Participants at high risk for disease progression, defined as:
1. 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 less than 8 weeks on ACE inhibitor or ARB before Screening or who have not yet reached maximally tolerated dose will enter the Run-in Period.
2. Participants who are on ACE inhibitor or ARB for a minimum of 8 weeks with Systolic Blood Pressure \< 140 mmHg in ≥ 75% of the readings within last 8 weeks.
3. Having two proteinuria measurements with each \> 3.5 g/day, the second measurement showing ≤50% decrease from the first measurement.
* All participants must receive prophylactic treatment with appropriate antibiotics while receiving Rituximab (RTX), and be willing to be vaccinated against Neisseria meningitidis
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 \< 50 RU/mL or kidney disease other than PMN
* History of kidney transplant or planned kidney transplant or dialysis during the Treatment Period
* History of other solid organ (heart, lung, small bowel, pancreas, or liver) or bone marrow 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 the study period
18 Years
75 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Alexion Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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Research Site
Loma Linda, California, United States
Research Site
San Diego, California, United States
Research Site
Minneapolis, Minnesota, United States
Research Site
Rochester, Minnesota, United States
Research Site
Houston, Texas, United States
Research Site
Buenos Aires, , Argentina
Research Site
CABA, , Argentina
Research Site
Ciudad de Buenos Aires, , Argentina
Research Site
Rosario, , Argentina
Research Site
Santa Fe, , Argentina
Research Site
Santa Fe, , Argentina
Research Site
Gosford, , Australia
Research Site
Parkville, , Australia
Research Site
Southport, , Australia
Research Site
Recife, , Brazil
Research Site
Salvador, , Brazil
Research Site
São Paulo, , Brazil
Research Site
São Paulo, , Brazil
Research Site
Baotou, , China
Research Site
Beijing, , China
Research Site
Guangzhou, , China
Research Site
Shenzhen, , China
Research Site
Créteil, , France
Research Site
Nice, , France
Research Site
Toulouse, , France
Research Site
Milan, , Italy
Research Site
Ranica, , Italy
Research Site
Torrette, , Italy
Research Site
Barcelona, , Spain
Research Site
Madrid, , Spain
Research Site
Seville, , Spain
Research Site
Toledo, , Spain
Research Site
Kaohsiung City, , Taiwan
Research Site
Taichung, , Taiwan
Research Site
Taoyuan District, , Taiwan
Research Site
Cambridge, , United Kingdom
Research Site
Leicester, , United Kingdom
Research Site
London, , United Kingdom
Research Site
Salford, , United Kingdom
Countries
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Central Contacts
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Alexion Pharmaceuticals, Inc. (Sponsor)
Role: CONTACT
Phone: 1-855-752-2356
Email: [email protected]
Other Identifiers
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ALXN1920-PMN-201
Identifier Type: OTHER
Identifier Source: secondary_id
2025-520780-40
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D9900C00002
Identifier Type: -
Identifier Source: org_study_id