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Unknown

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 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

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.

Find a Location

Who is running the clinical trial?

Tenet MedicinesLead Sponsor
2 Previous Clinical Trials
6 Total Patients Enrolled
ValenzaBio, Inc.Lead Sponsor
2 Previous Clinical Trials
60 Total Patients Enrolled
ACELYRIN Inc.Lead Sponsor
8 Previous Clinical Trials
1,098 Total Patients Enrolled

Media Library

VB119 (Unknown) Clinical Trial Eligibility Overview. Trial Name: NCT05441826 — Phase 2
Nephrotic Syndrome Research Study Groups: VB119
Nephrotic Syndrome Clinical Trial 2023: VB119 Highlights & Side Effects. Trial Name: NCT05441826 — Phase 2
VB119 (Unknown) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05441826 — Phase 2
~0 spots leftby Nov 2025
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