ClinicaliQ Trial Snapshot
- Study of ALXN1920 in Adult Participants With Primary Membranous Nephropathy (PMN) — Recruiting • Phase II • NCT07157787.
- ALXN1920 (a complement C3 inhibitor) is being tested against placebo in adults with primary membranous nephropathy, with efficacy measured by reduction in 24-hour urine protein-creatinine ratio (UPCR) as the primary outcome.
- Eligible participants are adult patients with PMN who are classified as high-risk for disease progression, narrowing the study population to those most likely to experience kidney function decline without intervention.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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).
Eligibility Snapshot
- : * 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.
- 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
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.