Currently Enrolling
Interventional

A Phase 2 Study of VB119 in Adult Subjects with Steroid-Sensitive Primary Minimal Change Disease (MCD) or Primary Focal Segmental Glomerulosclerosis (FSGS)

A Phase 2 Study of VB119 in Adult Subjects with Steroid-Sensitive Primary Minimal Change Disease (MCD) or Primary Focal Segmental Glomerulosclerosis (FSGS)

Brief Description

This is a Phase 2, open-label, multi-center, proof-of-concept study to evaluate the safety and efficacy of VB119 on the maintenance of remission and duration of response in adults with primary MCD or primary FSGS who previously responded to steroid therapy. VB119 will be administered 4 times during a 6 month period.

Email Phone (301) 755-9900
Site Name

Genesis Clinical Trials
Tampa, FL

Sponsor

ValenzaBio, Inc.

Study Drug

VB119

Estimated enrollment

20

Estimated end date

February 2023

If there is not a site for a clinical trial nearby, you can ask the study team about the possibility of travel reimbursements (i.e., paying you back for your travel costs). Alternatively, you can ask about the possibility of participating from home.
Currently Enrolling
Interventional

A Phase 2 Study of VB119 in Adult Subjects with Steroid-Sensitive Primary Minimal Change Disease (MCD) or Primary Focal Segmental Glomerulosclerosis (FSGS)

A Phase 2 Study of VB119 in Adult Subjects with Steroid-Sensitive Primary Minimal Change Disease (MCD) or Primary Focal Segmental Glomerulosclerosis (FSGS)

Brief Description

This is a Phase 2, open-label, multi-center, proof-of-concept study to evaluate the safety and efficacy of VB119 on the maintenance of remission and duration of response in adults with primary MCD or primary FSGS who previously responded to steroid therapy. VB119 will be administered 4 times during a 6 month period.

Trial is for people with

Steroid-Sensitive Primary Minimal Change Disease (MCD) or Primary Focal Segmental Glomerulosclerosis (FSGS)

Study Goal

The primary objective is to assess safety and efficacy of VB119 on maintenance of remission in subject with primary MCD or primary FSGS who are corticosteroid-dependent or frequently relapsing. Secondary objects are to evaluate change in proteinuria, change in renal function, characterize the pharmacokinetic profiles, and effects on B-cell depletion in subjects with primary MCD or primary FSGS.

What is involved for the Patient?

Patients will be asked to allow researchers to access medical history. The study team will also collect blood and urine samples at several timepoints. Patients will have a physical exam and an ECG at various timepoints.

About the drug or intervention

VB119 is a monoclonal antibody that targets the antigen CD19. VB119 has been shown to inhibit proliferation of B-cells.

Tampa, FL
Frequently Asked Questions

Nephrotic Syndrome is not a disease itself, but rather a group of signs and symptoms that result from damage in the part of the kidney that filters blood (glomeruli).

Common symptoms include:

  • Foamy urine (called proteinuria) caused by protein “spilling” into the urine
  • Severe swelling in parts of the body, most noticeably around the eyes, hands, feet, and abdomen (called edema)
  • Weight gain due to a buildup of extra fluid
  • Fatigue
  • Loss of appetite
  • Low levels of protein in the blood (hypoalbuminemia)
  • Higher than normal fat and cholesterol levels in the blood (hyperlipidemia)

Nephrotic Syndrome can typically be diagnosed with a urine test.

Nephrotic Syndrome can be “primary” or “secondary” in nature.

Diseases that affect only the kidneys are called primary causes of Nephrotic Syndrome. Doctors often call these diseases “idiopathic,” which means that they arise from an unknown cause. Some of these diseases include:

  • Minimal Change Disease (MCD) – most common in children
  • Focal Segmental Glomerulosclerosis (FSGS)
  • Membranous Nephropathy (MN) – most common in adults
  • IgA Nephropathy (IgAN)

Secondary Nephrotic Syndrome is caused by an underlying, systemic condition like diabetes, lupus, HIV, and others.

The Kidney Health Gateway is a website owned and operated by NephCure Kidney International. The purpose of this website is to help patients with rare forms of primary Nephrotic Syndrome get connected to expert care and cutting-edge treatment options. By answering a few questions about you or your loved one’s condition, we can provide you with a list of clinical trials and/or expert doctors in your area.

If you have additional questions, please visit NephCure.org or email Info@NephCure.org.

 

See other frequently asked questions
Did you know that some forms of kidney disease can be genetic?Researchers are continually discovering genetic causes of Nephrotic Syndrome.

Learn more about genetic causes of kidney disease and find out if you may be affected.