Last updated 7 days ago

Study of ALXN1920 in Adult Participants With Primary Membranous Nephropathy (PMN)

30 patients around the world

Available in Spain, Brazil, Argentina, United States

Alexion Pharmaceuticals, Inc.

1Research sites

30Patients around the world

This study is for people with

Nephropathy

Primary membranous nephropathy

To 75 Years

All Gender

: 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.

: 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.

Instituto Médico de la Fundación Estudios Clínicos - Rosario

Recruiting

Italia 428, Rosario - Santa Fe

StudyAUTUMN

SponsorAlexion Pharmaceuticals, Inc.

Study typeInterventional

Conditions

Primary membranous nephropathy

Requirements

To 75 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT07157787