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Immunosuppressant

Obinutuzumab for Childhood-Onset Nephrotic Syndrome (INShore Trial)

Phase 3

Waitlist Available

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

Must not have

History of genetic defects known to directly cause nephrotic syndrome

History of or current cancer, including solid tumors, hematological malignancies, and carcinoma in situ within the past 5 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 52 to week 76

Awards & highlights

Pivotal Trial

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am in complete remission with no swelling, low protein in my urine, and recent tests showing minimal to no protein.

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I had at least one relapse in the past 6 months despite being on or after stopping steroids or immunosuppressants.

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My kidney function, based on eGFR, is normal for my age.

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I was diagnosed with FRNS or SDNS before I turned 18.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a genetic condition known to cause severe kidney issues.

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I have not had any type of cancer, including early-stage, in the last 5 years.

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I cannot tolerate or am not allowed to have the study's treatments.

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I had two or more relapses in 6 months while on MMF for at least 6 months.

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I have not had major surgery requiring a hospital stay in the last 4 weeks.

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I am at high risk for serious bleeding or need treatments like blood transfusions.

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I have a kidney condition called secondary nephrotic syndrome.

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I have had progressive multifocal leukoencephalopathy in the past.

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I have had an organ or bone marrow transplant.

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My kidney condition did not improve with steroid treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 52 to week 76

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 52 to week 76

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 52 to week 76 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Percentage of Participants with Sustained Complete Remission

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Diphenhydramine Hydrochloride

2002

Completed Phase 4

~430

Prednisone

2014