Currently Enrolling
Interventional

A Phase 1b/2a Study of VB119 in Adult Subjects with Primary Membranous Nephropathy

A Phase 1b/2a Study of VB119 in Adult Subjects with Primary Membranous Nephropathy

Brief Description

This study is a Phase 1b/2a, open‑label, sequential-cohort, dose escalation, and dose expansion study to evaluate the safety, tolerability, PK, and PD of VB119 in subjects with primary MN. The study consists of 2 phases (dose escalation and dose expansion). Each subject may receive maintenance dosing at 6 months following the initial dose, if certain safety and PD criteria are met.
In the dose escalation phase, subjects will receive 2 bi-weekly doses of VB119 at the specified dose level, administered via intravenous (IV) infusion. After the first dose cohort (100 mg administered every 14 days for 2 doses, 200 mg cumulative dose), subjects in subsequent cohorts may receive 4 weekly doses rather than 2 bi-weekly doses, per determination by the Data Review Committee (DRC). The decision to shift to weekly dosing will rely on accumulating safety data and the onset and durability of B cell depletion effects.

Email Phone (301) 755-9900
Site Name

Sheffield, UK

Sponsor

ValenzaBio, Inc.

Study Drug

VB119

Estimated enrollment

30

Estimated end date

November 2022

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 1b/2a Study of VB119 in Adult Subjects with Primary Membranous Nephropathy

A Phase 1b/2a Study of VB119 in Adult Subjects with Primary Membranous Nephropathy

Brief Description

This study is a Phase 1b/2a, open‑label, sequential-cohort, dose escalation, and dose expansion study to evaluate the safety, tolerability, PK, and PD of VB119 in subjects with primary MN. The study consists of 2 phases (dose escalation and dose expansion). Each subject may receive maintenance dosing at 6 months following the initial dose, if certain safety and PD criteria are met.
In the dose escalation phase, subjects will receive 2 bi-weekly doses of VB119 at the specified dose level, administered via intravenous (IV) infusion. After the first dose cohort (100 mg administered every 14 days for 2 doses, 200 mg cumulative dose), subjects in subsequent cohorts may receive 4 weekly doses rather than 2 bi-weekly doses, per determination by the Data Review Committee (DRC). The decision to shift to weekly dosing will rely on accumulating safety data and the onset and durability of B cell depletion effects.

Trial is for people with

Primary Membranous Nephropathy

Study Goal

The primary objective of this study to define the safety and tolerability of ascending doses of VB119 in subjects with primary membranous nephropathy. Secondary objects are to investigate a range of dose levels, characterize the pharmacokinetic profiles, effects on B-cell depletion, effects on anti-PLA2R antibodies and proteinuria in subjects with primary membranous nephropathy.

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

Sheffield, UK
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.