Study Of ALXN1920 In Adult Participants With Primary Membranous Nephropathy (PMN)

Overview

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).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

* 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:

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:

* 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: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 9/16/2025. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Fernando Fervenza

Contact us for the latest status

Contact information:

Corbyn Bendtsen

(507) 284-0366

bendtsen.corbyn@mayo.edu

More information

Publications

Publications are currently not available