RecruitingPrimary Membranous Nephropathy
Study of ALXN1920 in Adult Participants With Primary Membranous Nephropathy (PMN)
Eligible age
18–75 yrs
Accepts
All genders
Locations
3 states
Healthy volunteers
No
See if you qualify for this study
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About this study
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 creatinine ratio (UPCR).
Sponsor: Alexion Pharmaceuticals, Inc.
You may qualify if…
- ✓ Participants who have a documented diagnosis of PMN, established by positive antiPLA2R antibody level (\> 20 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:
- ✓ 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.
- ✓ eGFR60 mL/min/1.73 m2 during Screening calculated by CKD-EPI 2021 creatinine formula
- ✓ All participants must receive prophylactic treatment with appropriate antibiotics while receiving Rituximab (RTX), and be willing to be vaccinated against Neisseria meningitidis
You may not qualify if…
- ✕ 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 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
- ✕ Initiation or dose adjustment of SGLT2i within 12 weeks prior to randomization or planned adjustment of GSLT2i dose throughout the treatment period.
Where it's recruiting
Source: ClinicalTrials.gov · NCT07157787 · last updated 2026-06-18