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Immunosuppressant
Obinutuzumab for Childhood-Onset Nephrotic Syndrome (INShore Trial)
Phase 3
Recruiting
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must be in complete remission defined by the absence of edema, UPCR <= 0.2 g/g at screening and have three consecutive daily urine dipstick readings of trace or negative for protein within the week prior to randomization
Must have had at least one relapse in the 6 months prior to screening, after discontinuation of or while receiving oral corticosteroids and/or immunosuppressive therapy to prevent relapses
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at days 1, 15 28, 84, 168, 182, 224, 364, and at early study discontinuation visit (unscheduled visit at the time of discontinuation from study, any time between day 1 and day 364)
Awards & highlights
INShore Trial Summary
This trial tests a new drug's safety, effectiveness, and how it works in children and young adults with kidney disease.
Who is the study for?
This trial is for children and young adults aged 2-25 with frequently relapsing or steroid-dependent nephrotic syndrome diagnosed before age 18. Participants must be in remission, have normal kidney function, and not have received certain treatments recently. They should agree to contraception if applicable and cannot join if they've had transplants, intolerances to study drugs, significant other diseases, active infections, immunodeficiencies including HIV, recent major surgery or cancer history within 5 years.Check my eligibility
What is being tested?
The study compares the effectiveness and safety of obinutuzumab versus mycophenolate mofetil (MMF) in managing nephrotic syndrome that often relapses or depends on steroids. It's an open-label trial where everyone knows which treatment they're getting. The participants' response to treatment will also be measured through PK/PD assessments.See study design
What are the potential side effects?
Potential side effects include allergic reactions to medication components like acetaminophen/paracetamol or diphenhydramine hydrochloride used during treatment administration. Obinutuzumab may cause infusion-related reactions while MMF can lead to gastrointestinal issues and increase infection risk.
INShore Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am in complete remission with no swelling, low protein in my urine, and recent tests showing minimal to no protein.
Select...
I had at least one relapse in the past 6 months despite being on or after stopping steroids or immunosuppressants.
Select...
My kidney function, based on eGFR, is normal for my age.
Select...
I was diagnosed with FRNS or SDNS before I turned 18.
INShore Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at days 1, 15 28, 84, 168, 182, 224, 364, and at early study discontinuation visit (unscheduled visit at the time of discontinuation from study, any time between day 1 and day 364)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at days 1, 15 28, 84, 168, 182, 224, 364, and at early study discontinuation visit (unscheduled visit at the time of discontinuation from study, any time between day 1 and day 364)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of Participants with Sustained Complete Remission at 1 year
Secondary outcome measures
Cumulative Corticosteroid Dose
Mean Change in "General Fatigue" Domain of Pediatric Quality of Life Inventory (PedsQL) Multidimensional Fatigue Scale Total Score
Mean Change in "Physical Functioning" Domain of PedsQL Quality of Life Inventory
+10 moreINShore Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Obinutuzumab (Group A)Experimental Treatment5 Interventions
Participants in Group A will receive obinutuzumab 1000 milligrams (mg) (or 20 mg/ kilogram [kg] for participants <45 kg) administered by intravenous (IV) infusion on Days 1, 15, 168 (Week 24), and 182 (Week 26).
Group II: MMF (Group B)Active Control2 Interventions
Participants in Group B will receive oral MMF 600 mg/m^2 twice a day (BID) (target 1200 mg/m2/day in divided doses, maximum 2 g/day) to Week 52.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Obinutuzumab
2015
Completed Phase 3
~3250
Prednisone
2014
Completed Phase 4
~2370
Methylprednisolone
2015
Completed Phase 4
~2280
Diphenhydramine Hydrochloride
2002
Completed Phase 4
~430
Find a Location
Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,430 Previous Clinical Trials
1,089,538 Total Patients Enrolled
1 Trials studying Nephrotic Syndrome
26 Patients Enrolled for Nephrotic Syndrome
Clinical TrialsStudy DirectorHoffmann-La Roche
2,201 Previous Clinical Trials
888,860 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a genetic condition known to cause severe kidney issues.I haven't been in another drug trial within the last 30 days or 5 half-lives of the drug.I had two or more relapses in 6 months while on MMF for at least 6 months.I do not have any major health issues that would stop me from joining the study.I am in complete remission with no swelling, low protein in my urine, and recent tests showing minimal to no protein.You currently abuse alcohol or drugs, or have a history of doing so.You have a history of weakened immune system, including HIV infection or other severe immune system disorders.I am a woman who can have children and have had negative pregnancy tests before starting the study.I have not had major surgery requiring a hospital stay in the last 4 weeks.I am at high risk for serious bleeding or need treatments like blood transfusions.I have a kidney condition called secondary nephrotic syndrome.I had at least one relapse in the past 6 months despite being on or after stopping steroids or immunosuppressants.I am a male and agree to either not have sex or use birth control, and not donate sperm for 3 months after my last MMF dose.I have not had any type of cancer, including early-stage, in the last 5 years.I cannot tolerate or am not allowed to have the study's treatments.I haven't taken immunosuppressive drugs other than MMF or oral steroids in the last 2 months.I have had progressive multifocal leukoencephalopathy in the past.I haven't had a serious infection or been treated with strong antibiotics in the last month.I might need steroids for reasons other than kidney-related swelling, as per my doctor.I have had an organ or bone marrow transplant.My kidney function, based on eGFR, is normal for my age.My kidney condition did not improve with steroid treatment.I was diagnosed with FRNS or SDNS before I turned 18.I had cyclophosphamide and my condition worsened after stopping it.
Research Study Groups:
This trial has the following groups:- Group 1: Obinutuzumab (Group A)
- Group 2: MMF (Group B)
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are adults of legal age being enlisted for this research project?
"This clinical trial's inclusion criteria dictates that the youngest acceptable patient is 2 years old and must not exceed 25."
Answered by AI
Has Obinutuzumab (Group A) been given the green light by the FDA?
"The safety of obinutuzumab (Group A) is assessed as 3 on a scale from 1 to 3, since the Phase 3 trial provides evidence for its efficacy and security."
Answered by AI
Is this experiment open for enrollment?
"According to the information available on clinicaltrials.gov, this medical research is still recruiting participants for their study which was initially unveiled on March 29th 2023 and most recently updated on May 12th 2023."
Answered by AI
What is the current enrollment size of this trial?
"Affirmative. According to clinicaltrials.gov data, this medical trial is actively enrolling patients since it was initially posted on March 29th of 2023 and last revised on May 12th of the same year. Approximately 80 participants need to be recruited from 13 different sites."
Answered by AI
Am I eligible to be a volunteer for this medical experiment?
"This clinical trial seeks 80 youths between the ages of 2 and 25 with childhood nephrotic syndrome. The participants must satisfy various prerequisites such as having a Diagnosis of FRNS or SDNS before 18, complete remission without edema, UPCR under 0.2g/g at screening, one relapse in the 6 months before screening after discontinuation of corticosteroids and immunosuppressive therapy, eGFR within normal range for age etc. As well as abstaining from sexual intercourse during treatment period, female participants need to use highly effective contraception while males should refrain from donating sperm over the same duration."
Answered by AI
How many research centers are participating in this trial?
"At this time, 13 distinct medical sites are recruiting patients for the study. These include Hackensack, Tokyo and Bydgoszcz in addition to 10 other locations. It is advised to choose a near-by site if one wishes to minimize travel demands associated with participation."
Answered by AI
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