Status:
RECRUITING
Study of ALXN1920 in Adult Participants With Primary Membranous Nephropathy (PMN)
Lead Sponsor:
Alexion Pharmaceuticals, Inc.
Collaborating Sponsors:
AstraZeneca
Conditions:
Primary Membranous Nephropathy
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The primary objective of this study is to evaluate the efficacy of ALXN1920 compared with placebo in participants with PMN who are at a high risk for disease progression using 24-hour urine protein cr...
Eligibility Criteria
Inclusion
- Participants who have a documented diagnosis of PMN, established by positive antiPLA2R antibody level (\> 50 RU/mL) at Screening, which must be confirmed by a central 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 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.
- 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.
- 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
- 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 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
- Note: Additional inclusion/exclusion criteria may apply, per protocol.
Key Trial Info
Start Date :
September 19 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 12 2027
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT07157787
Start Date
September 19 2025
End Date
February 12 2027
Last Update
December 29 2025
Active Locations (39)
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1
Research Site
Loma Linda, California, United States, 92354
2
Research Site
San Diego, California, United States, 92123
3
Research Site
Minneapolis, Minnesota, United States, 55435
4
Research Site
Rochester, Minnesota, United States, 55905