What side effects are associated with this type of intervention?

The most common treatments for Nephrotic Syndrome, particularly in primary Minimal Change Disease (MCD) and Focal Segmental Glomerulosclerosis (FSGS), include corticosteroids, cyclophosphamide, mycophenolate mofetil (MMF), and calcineurin inhibitors. Corticosteroids can cause side effects such as weight gain, hypertension, hyperglycemia, increased risk of infections, and osteoporosis. Cyclophosphamide may lead to bone marrow suppression, increased infection risk, and potential bladder toxicity. MMF is associated with gastrointestinal disturbances, bone marrow suppression, and increased infection risk. Calcineurin inhibitors can cause nephrotoxicity, hypertension, and hyperglycemia. These side effects necessitate careful monitoring and management during treatment.

What prior FDA approvals exist?

The FDA has approved several treatments for Nephrotic Syndrome, particularly for primary Minimal Change Disease (MCD) and primary Focal Segmental Glomerulosclerosis (FSGS). These include corticosteroids like prednisone, which are often the first line of treatment. For patients who do not respond to steroids, immunosuppressive agents such as cyclophosphamide, cyclosporine, and mycophenolate mofetil (MMF) are used. Rituximab, although not specifically approved for these conditions, has been used off-label for steroid-resistant cases. These treatments aim to induce and maintain remission and manage relapses, aligning with the goals of the VB119 trial.

What other types of research exist?

Promising novel alternatives to VB119 for Nephrotic Syndrome patients in 2024 include: <ol> <li>Rituximab: A monoclonal antibody targeting CD20, showing efficacy in reducing proteinuria and maintaining remission in MCD and FSGS.</li> <li></li> </ol> Mycophenolate Mofetil (MMF): An immunosuppressive agent used as an alternative to steroids, particularly in patients who are steroid-resistant or intolerant. 3. Calcineurin Inhibitors (CNIs) such as Tacrolimus and Cyclosporine: Effective in reducing proteinuria and maintaining remission in steroid-resistant cases. 4. Sparsentan: A dual endothelin receptor and angiotensin receptor blocker, currently under investigation for its potential to reduce proteinuria and preserve kidney function in FSGS. 5. Voclosporin: A novel calcineurin inhibitor with a potentially better safety profile, under investigation for its efficacy in nephrotic syndrome.

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VB119 for Focal Segmental Glomerulosclerosis

Phase 2

Waitlist Available

Research Sponsored by Tenet Medicines

Eligibility Criteria Checklist

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

Must have

Has a history of steroid-sensitive MCD or FSGS with complete remission of proteinuria after corticosteroid use

Female subjects of non-childbearing potential must be surgically sterile or postmenopausal

Must not have

Has an estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2 at Screening

Has secondary causes of MCD or FSGS (eg, malignancy, hepatitis B or C, HIV, SLE, or other autoimmune diseases)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from day 1 to day 337

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new treatment called VB119 to see if it can help keep certain kidney diseases under control. It focuses on adults with specific kidney conditions (MCD or FSGS) who have shown improvement with previous treatments. The goal is to see if VB119 can maintain their improvement and make it last longer.

Who is the study for?

Adults over 18 with a kidney biopsy-proven diagnosis of primary MCD or FSGS within the last 10-20 years, who responded to steroids before and have had significant proteinuria in the past 2 years. Participants must be on a stable prednisone dose and have controlled blood pressure. Women must be non-childbearing or use contraception; men agree not to donate sperm for 4 months post-trial.

What is being tested?

The trial is testing VB119's effectiveness in maintaining remission and prolonging response duration in adults with primary MCD or FSGS who previously responded to steroid therapy. It's a Phase 2 study across multiple centers, focusing on those who've seen benefits from steroids.

What are the potential side effects?

Potential side effects of VB119 are not specified here but typically could include reactions at the infusion site, changes in blood pressure or kidney function, immune system responses, or other drug-specific effects that will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My kidney condition improved completely after using steroids.

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I am a woman who cannot have children because I am either surgically sterile or postmenopausal.

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I agree not to donate sperm for 125 days after my last dose of the study drug.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My kidney function is reduced, with an eGFR below 60.

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My kidney condition is not due to cancer, hepatitis, HIV, lupus, or other autoimmune diseases.

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I have type 1 or type 2 diabetes.

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I have been diagnosed with or have a history of lupus.

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I have an ongoing infection, such as TB, hepatitis, HIV, or a UTI.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from day 1 to day 337

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from day 1 to day 337

This trial's timeline: 3 weeks for screening, Varies for treatment, and from day 1 to day 337 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 adverse events of special interest (AESIs)

Incidence of serious adverse events (SAEs)

Incidence of treatment-emergent adverse events (TEAEs)

+1 more

Secondary study objectives

Change in UPCR

Change in eGFR

Proportion of subjects that are recurrence-free

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: VB119Experimental Treatment1 Intervention

VB119 100 or 200mg IV doses administered 4 times

0 / 9Eligibility criteria met

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 Nephrotic Syndrome, particularly in conditions like Minimal Change Disease (MCD) and Focal Segmental Glomerulosclerosis (FSGS), include corticosteroids, immunosuppressive agents, and supportive care. Corticosteroids such as prednisone reduce inflammation and suppress the immune system, helping to decrease proteinuria and induce remission. Immunosuppressive agents like cyclophosphamide, mycophenolate mofetil (MMF), and rituximab target various aspects of the immune response to prevent further kidney damage and maintain remission. Supportive care, including ACE inhibitors or ARBs, helps manage symptoms like hypertension and proteinuria. These treatments are essential for Nephrotic Syndrome patients as they aim to reduce relapses, maintain kidney function, and improve overall quality of life.