Currently Enrolling
Interventional

Visionary

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Sibeprenlimab Administered Subcutaneously in Subjects with Immunoglobulin A Nephropathy (IgAN)

Brief Description

This phase 3 trial will assess the efficacy and safety of sibeprenlimab administered SC once every 4 weeks as an add-on to standard of care (SOC) treatment (eg, angiotensin-converting enzyme inhibitors [ACEIs] and/or angiotensin receptor blockers [ARBs]). Furthermore, subjects who are on a stable dose of sodium-glucose cotransporter-2 inhibitors (SGLT2i) therapy for IgAN, in addition to ACEIs and/or ARBs, may participate in the trial if treatment was initiated at least 3 months prior to
screening.

Trial Physician / Study Coordinator

Marissa Baltazar

Email
Site Name

Colorado Kidney Care PC
130 Rampart Way, Suite 175, Denver, CO 80230

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Study Drug

Sibeprenlimab

Estimated enrollment

470

Estimated end date

2026

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

Visionary

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Sibeprenlimab Administered Subcutaneously in Subjects with Immunoglobulin A Nephropathy (IgAN)

Brief Description

This phase 3 trial will assess the efficacy and safety of sibeprenlimab administered SC once every 4 weeks as an add-on to standard of care (SOC) treatment (eg, angiotensin-converting enzyme inhibitors [ACEIs] and/or angiotensin receptor blockers [ARBs]). Furthermore, subjects who are on a stable dose of sodium-glucose cotransporter-2 inhibitors (SGLT2i) therapy for IgAN, in addition to ACEIs and/or ARBs, may participate in the trial if treatment was initiated at least 3 months prior to
screening.

Trial is for people with

Immunoglobulin A Nephropathy

Study Goal

Sibeprenlimab is being developed for the treatment of immunoglobin A nephropathy (IgAN), a chronic disease affecting the kidneys which is characterized clinically by proteinuria, hematuria, and progressive decline of glomerular filtration rate and histologically by deposition of Immunoglobulin A (IgA) in the kidney. This phase 3 trial will assess the efficacy and safety of sibeprenlimab administered SC once every 4 weeks as an add-on to standard of care (SOC) treatment.

What is involved for the Patient?

Subjects will be evaluated throughout the trial for safety, efficacy, pharmacodynamics (PD), pharmacokinetics (PK), and immunogenicity assessments. The total trial duration for each subject will be approximately 121 weeks (assuming up to60 days [approximately 9 weeks] for screening, 26 doses administered once every4 weeks from Day 1 to Week 100, a follow-up visit in Week 104, and ending with an end-of-trial visit in Week 112).

About the drug or intervention

Sibeprenlimab (VIS649) is a humanized IgG2 monocolonal antibody directed against the functionally conserved receptor binding domain of APRIL, blocking binding to its receptors, TACI, and BCMA.

Denver, CO
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.