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Currently Enrolling
Interventional

The INShore Study

A Study to Evaluate the Efficacy and Safety of Obinutuzumab Versus MMF in Participants With Childhood Onset Idiopathic Nephrotic Syndrome (INShore)

Brief Description

This open-label, randomized multicenter study is to assess the efficacy, safety, and pharmacokinetics (PK)/pharmacodynamics (PD) of obinutuzumab compared with mycophenolate mofetil (MMF) in children and young adults (aged >= 2-25 years) with frequently relapsing nephrotic syndrome (FRNS) or steroid-dependent nephrotic syndrome (SDNS).

Email Phone
Site Name

Children's Healthcare of Atlanta Center for Advanced Pediatrics

Sponsor

Hoffman-La Roche

Study Drug

obinutuzumab

Estimated enrollment

80

Estimated end date

8-15-2026

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

The INShore Study

A Study to Evaluate the Efficacy and Safety of Obinutuzumab Versus MMF in Participants With Childhood Onset Idiopathic Nephrotic Syndrome (INShore)

Brief Description

This open-label, randomized multicenter study is to assess the efficacy, safety, and pharmacokinetics (PK)/pharmacodynamics (PD) of obinutuzumab compared with mycophenolate mofetil (MMF) in children and young adults (aged >= 2-25 years) with frequently relapsing nephrotic syndrome (FRNS) or steroid-dependent nephrotic syndrome (SDNS).

Trial is for people with

This clinical trial is recruiting children and young people between 2 and 25 years of age with idiopathic nephrotic syndrome that started during childhood.

Study Goal

The purpose of this clinical trial is to compare the effects of obinutuzumab in comparison to MMF in people with childhood-onset idiopathic nephrotic syndrome. People who take part in this clinical trial will receive either obinutuzumab or MMF.

What is involved for the Patient?

During a ‘52 Week Treatment Period’ participants will be given the clinical trial treatment (obinutuzumab or MMF) for 52 weeks (around 1 year), and will be seen regularly (at visits between 2 and 8 weeks apart) by the clinical trial doctor, for up to 12 visits. These visits will be to see how the participant is responding to the treatment and any side effects they may be having.
After the ‘52 Week Treatment Period’ participants may enter the ‘Post Week-52 Extension Period’. They will be seen by the clinical trial doctor every 12 weeks until the last participant who joins the clinical trial reaches their Week 52 visit.
Participants will enter the ‘Safety Follow-up Period’ at either 1) time of early withdrawal, 2) at the time the last participant reaches their Week 52 visit, or 3) if the sponsor terminates the trial, and will continue to be seen by the clinical trial doctor approximately every 3 months. Participants who have not received obinutuzumab will return for a visit only once during the ‘Safety Follow-up Period’, 3 months after they have withdrawn or completed the trial. Participants who have received obinutuzumab will be monitored throughout the safety follow-up period until they have fulfilled both of the following criteria:
1. Specific immune cells, known as peripheral B cells, have returned to pre-treatment levels (i.e. the same levels as before being given obinutuzumab treatment) or to within the normal range for this population, whichever is lower

2. The last dose of obinutuzumab was at least 12 months ago

OR, until the last participant enrolled completes the safety follow-up requirements, up to a maximum of 18 months from the last dose of obinutuzumab, after which time the clinical trial will end.
Participants are free to stop trial treatment and leave the clinical trial at any time.

Atlanta, GA
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.

 

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