Budoprutug for Membranous Nephropathy
(PrisMN Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called budoprutug for individuals with primary membranous nephropathy (PMN), a kidney condition. Researchers aim to determine the safety and tolerability of the treatment at three different dose levels. Suitable participants have PMN, a specific type of antibody, and stable kidney function. This trial is significant for those interested in new treatment options for their condition. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group, providing participants an opportunity to contribute to important advancements in PMN treatment.
Do I need to stop my current medications for the trial?
The trial does not specify if you need to stop your current medications. However, it mentions that participants should have stable RAAS inhibitor therapy, which suggests you may need to continue that specific medication.
Is there any evidence suggesting that budoprutug is likely to be safe for humans?
Research has shown that budoprutug has undergone safety testing in earlier studies. One study focused on assessing the drug's safety, and patients generally tolerated the treatment well. No serious side effects were directly linked to budoprutug. However, as with any medication, some side effects could occur, though none were severe in previous trials.
Since the current trial is in a later phase, budoprutug has passed initial safety checks. This indicates the drug is safe enough for further testing, but participants should remain aware of possible side effects. It is important to discuss any concerns with a healthcare provider before joining a trial.12345Why do researchers think this study treatment might be promising for membranous nephropathy?
Unlike traditional treatments for membranous nephropathy, which often involve immunosuppressants like corticosteroids or calcineurin inhibitors, Budoprutug presents a novel approach. Budoprutug is unique because it targets specific pathways in the immune system, aiming to reduce inflammation and proteinuria more precisely without broadly suppressing the immune response. Researchers are excited about Budoprutug because it has the potential to offer a more targeted treatment with fewer side effects, improving the quality of life for patients with this kidney condition. Additionally, Budoprutug's unique mechanism of action might address the underlying causes of the disease more effectively, offering hope for better long-term outcomes.
What evidence suggests that budoprutug might be an effective treatment for membranous nephropathy?
Research has shown that budoprutug might help treat membranous nephropathy, a kidney disorder. Early clinical data suggest that budoprutug can significantly reduce certain immune cells, quickly lower harmful proteins that attack the body, and even lead to recovery in some patients. In one study, by Week 48, three patients fully recovered, and two showed partial improvement. These findings suggest that budoprutug could effectively manage this kidney condition. Participants in this trial will join one of the various treatment arms, each testing different dose levels of budoprutug.12678
Are You a Good Fit for This Trial?
This trial is for adults with Primary Membranous Nephropathy (PMN), a kidney condition. Participants must have certain levels of kidney function, blood pressure control, and B cell counts. They should be on stable RAAS inhibitor therapy and not pregnant or breastfeeding. Those with secondary PMN, recent major surgeries, high-risk infections, cancer history, or recent immunosuppressant use are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive three intravenous dose regimens of budoprutug on Day 1, Day 15, Day 169, and Day 183
Follow-up
Participants are monitored for safety and effectiveness after treatment, with extended follow-up for B-cell recovery as needed
What Are the Treatments Tested in This Trial?
Interventions
- Budoprutug
Find a Clinic Near You
Who Is Running the Clinical Trial?
Climb Bio, Inc.
Lead Sponsor