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Interventional Study
a clinical trial in which a new drug or device is used to measure a specific outcome.
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).
Phone
Site Name
Nicklaus Children's Hospital
Sponsor
Hoffman-La Roche
Study Drug
obinutuzumab
Estimated enrollment
80
Estimated end date
8-15-2026
Interventional Study
a clinical trial in which a new drug or device is used to measure a specific outcome.
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.
