ALXN1920 for Membranous Nephropathy
(AUTUMN Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called ALXN1920 for individuals with membranous nephropathy (PMN). The goal is to determine if ALXN1920 can reduce protein levels in the urine, a sign of kidney damage, compared to a placebo. Participants will receive either ALXN1920 or a placebo, alongside standard treatments like ACE inhibitors or Rituximab. The trial seeks individuals diagnosed with PMN who are at high risk for their condition to worsen and are already managing their blood pressure. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering a chance to contribute to advancements in kidney disease treatment.
Do I have to stop taking my current medications for the trial?
The trial requires participants to be on an ACE inhibitor or ARB for at least 8 weeks before screening and throughout the study. You cannot use SGLT2i, MRA, or ERA medications within 8 weeks before joining the trial and during the study.
Is there any evidence suggesting that ALXN1920 is likely to be safe for humans?
Research has shown that ALXN1920 has been tested in people before. It successfully completed at least one earlier trial that assessed its safety and tolerability, indicating no major safety issues have been found in the studies conducted so far.
However, the current trial is in an early stage, meaning the treatment is still under careful monitoring for safety and side effects. Participants might experience some side effects, but the exact details remain unknown.
Prospective participants should discuss any potential risks or side effects with the trial team.12345Why do researchers think this study treatment might be promising?
Researchers are excited about ALXN1920 for membranous nephropathy because it offers a new mechanism of action by targeting the immune system differently than current treatments. Unlike standard options like corticosteroids and immunosuppressants, which broadly suppress the immune response, ALXN1920 specifically targets and modulates certain immune pathways, potentially reducing side effects. Additionally, the subcutaneous administration of ALXN1920 could offer more convenience and ease for patients compared to intravenous options. This novel approach could lead to better outcomes and improved quality of life for those affected by this kidney condition.
What evidence suggests that ALXN1920 might be an effective treatment for membranous nephropathy?
Research shows that ALXN1920, which participants in this trial may receive, might help people with membranous nephropathy by lowering protein levels in urine. High protein levels can indicate improper kidney function. Earlier studies found that ALXN1920 slowed the disease, potentially keeping the kidneys healthier for longer. Initial results suggest that ALXN1920 may outperform a placebo, another treatment option in this trial, in managing the condition. So far, the treatment has shown promise in managing the symptoms of this kidney disease.12367
Are You a Good Fit for This Trial?
This trial is for adults with Primary Membranous Nephropathy (PMN), a kidney condition that can lead to high levels of protein in the urine. Participants should be at high risk for disease progression but specific inclusion and exclusion criteria details are not provided.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive ALXN1920 or placebo subcutaneously along with background treatment of ACE/ARB and Rituximab
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- ALXN1920
Find a Clinic Near You
Who Is Running the Clinical Trial?
Alexion Pharmaceuticals, Inc.
Lead Sponsor
Dr. Alberto R. Martinez
Alexion Pharmaceuticals, Inc.
Chief Medical Officer since 2010
MD from University of Sao Paulo
Marc Dunoyer
Alexion Pharmaceuticals, Inc.
Chief Executive Officer since 2021
PhD in Molecular Biology
AstraZeneca
Industry Sponsor
Sir Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Dr. Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology