What side effects are associated with this type of intervention?

The most common treatments for Membranous Glomerulonephritis include corticosteroids, cyclophosphamide, and other immunosuppressive agents. Corticosteroids can cause side effects such as weight gain, hypertension, diabetes, osteoporosis, and increased risk of infections. Cyclophosphamide is associated with side effects like bone marrow suppression, increased risk of infections, hemorrhagic cystitis, and potential long-term risks such as infertility and secondary malignancies. Other immunosuppressive agents, such as mycophenolate mofetil and calcineurin inhibitors, can also lead to increased susceptibility to infections, gastrointestinal disturbances, and potential nephrotoxicity. It is important for patients to discuss these potential side effects with their healthcare provider to manage and mitigate risks effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for Membranous Glomerulonephritis (MGN), primarily focusing on immunosuppressive therapies and corticosteroids. Commonly used drugs include cyclophosphamide, which suppresses the immune system to reduce kidney inflammation, and corticosteroids like prednisone, which help control inflammation and immune responses. Other treatments may involve the use of calcineurin inhibitors such as cyclosporine and tacrolimus. These therapies aim to reduce proteinuria and preserve kidney function in patients with MGN.

What other types of research exist?

Promising novel alternatives to VB119 for Membranous Glomerulonephritis patients include rituximab and other emerging biological agents. Rituximab, a monoclonal antibody targeting CD20 on B cells, has shown efficacy in reducing proteinuria and stabilizing kidney function. Additionally, new biological therapies targeting specific autoantibodies and immune pathways are under investigation and may offer personalized treatment options in the near future.

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Unknown

VB119 for Kidney Disease

Phase 1 & 2

Waitlist Available

Research Sponsored by ACELYRIN Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 18 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new treatment called VB119 to see if it is safe and effective. It focuses on people with a kidney condition called primary MN. Researchers want to understand how VB119 works in the body and if it can help these patients.

Who is the study for?

This trial is for adults with a confirmed diagnosis of primary Membranous Nephropathy (kidney disease) within the last 10 years, showing high levels of protein in urine. Participants must have stable blood pressure and agree to use effective contraception. Those with certain infections, diabetes, low white blood cell counts, or other autoimmune diseases like lupus are excluded.

What is being tested?

The study tests VB119's safety and effectiveness on kidney function in patients with Membranous Nephropathy. It's an early-stage trial where doses increase over time among different groups to find the right balance between benefits and side effects.

What are the potential side effects?

Specific side effects for VB119 aren't listed here but may include typical drug reactions such as nausea, allergic responses, potential impact on blood cells or organ functions which will be closely monitored throughout the trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 18 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of Clinical Laboratory Assessments

Incidence of Treatment-Emergent Adverse Events

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: VB119 dose escalationExperimental Treatment1 Intervention

Dose escalation phase followed by a dose expansion phase. VB119 to be administered as intravenous infusions.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Membranous Glomerulonephritis (MN) include immunosuppressive agents such as cyclophosphamide, calcineurin inhibitors (e.g., cyclosporine, tacrolimus), and corticosteroids. These treatments work by suppressing the immune system to reduce the production of antibodies that attack the glomerular basement membrane, thereby decreasing inflammation and preventing further kidney damage. This is crucial for MN patients as it helps to preserve kidney function, reduce proteinuria, and improve long-term outcomes. Understanding these mechanisms is important for tailoring treatment plans and managing potential side effects effectively.

The management of membranous nephropathy-an update.[Therapeutic strategies for membranous nephropathy: guideline from the Italian Society of Nephrology].Recent developments in the management of membranous nephropathy.