ALXN1920: Participants will receive ALXN1920 SC infusion.
Placebo: Participants will receive Placebo SC infusion.
Study 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 creatinine ratio (UPCR).
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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.
* Use of traditional Chinese medicines or Chinese proprietary medicines with systemic immunosuppressive properties within 6 months prior to screening.
* Use of MRA, or ERA within 12 weeks prior to randomization and throughout the study period
Note: Additional inclusion/exclusion criteria may apply, per protocol.
Primary outcome measure(s)
Change From Baseline in Proteinuria Based on 24-hour UPCR at Week 26 — Baseline, Week 26
Trial sites (40)
Facility
City
Region
Status
Research Site
Loma Linda
California
Recruiting
Research Site
San Diego
California
Recruiting
Research Site
Minneapolis
Minnesota
Recruiting
Research Site
Rochester
Minnesota
Recruiting
Research Site
Houston
Texas
Recruiting
Research Site
Buenos Aires
Argentina
Recruiting
Research Site
CABA
Argentina
Recruiting
Research Site
Ciudad de Buenos Aires
Argentina
Recruiting
Research Site
La Plata
Argentina
Not Yet Recruiting
Research Site
Rosario
Argentina
Recruiting
Research Site
Santa Fe
Argentina
Withdrawn
Research Site
Santa Fe
Argentina
Withdrawn
Research Site
Gosford
Australia
Active Not Recruiting
Research Site
Parkville
Australia
Recruiting
Research Site
Southport
Australia
Recruiting
Research Site
Recife
Brazil
Recruiting
Research Site
Salvador
Brazil
Recruiting
Research Site
São Paulo
Brazil
Recruiting
Research Site
São Paulo
Brazil
Recruiting
Research Site
Baotou
China
Recruiting
Research Site
Beijing
China
Recruiting
Research Site
Guangzhou
China
Recruiting
Research Site
Shenzhen
China
Recruiting
Research Site
Créteil
France
Withdrawn
Research Site
Nice
France
Recruiting
Research Site
Toulouse
France
Recruiting
Research Site
Milan
Italy
Recruiting
Research Site
Ranica
Italy
Recruiting
Research Site
Torrette
Italy
Recruiting
Research Site
Barcelona
Spain
Recruiting
Research Site
Madrid
Spain
Recruiting
Research Site
Seville
Spain
Recruiting
Research Site
Toledo
Spain
Recruiting
Research Site
Kaohsiung City
Taiwan
Recruiting
Research Site
Taichung
Taiwan
Recruiting
Research Site
Taoyuan
Taiwan
Recruiting
Research Site
Cambridge
United Kingdom
Recruiting
Research Site
Leicester
United Kingdom
Recruiting
Research Site
London
United Kingdom
Recruiting
Research Site
Salford
United Kingdom
Recruiting
More Alexion Pharmaceuticals, Inc. trials in the UK
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.