Obinutuzumab for Childhood-Onset Nephrotic Syndrome
(INShore Trial)

Recruiting in Palo Alto (17 mi)

+61 other locations

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Hoffmann-La Roche

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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).

Research Team

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Eligibility Criteria

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.

Inclusion Criteria

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

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.

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Exclusion 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.

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Treatment Details

Interventions

MMF (Immunosuppressant)
Obinutuzumab (Monoclonal Antibodies)

Trial OverviewThe 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.

Participant Groups

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.

MMF is already approved in Canada for the following indications: