NCT05627557

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

A Phase III, International, Multicenter, Randomised Open Label Study to Evaluate the Efficacy and Safety of Obinutuzumab Versus MMF in Patients With Childhood Onset Idiopathic Nephrotic Syndrome

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 85 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 2 Years – 25 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Childhood Idiopathic Nephrotic Syndrome

Interventions

Type	Name	Description
DRUG	Obinutuzumab	Obinutuzumab will be administered as per schedule specified in the respective arm.
DRUG	MMF	MMF will be administered as per schedule specified in the respective arm.
DRUG	Prednisone	Participants taking prednisone or equivalent at randomization will follow a guided tapering schedule to reach the goal of 0mg/day by Weeks 4-6 (and no later than Week 8 following randomization and continue without prednisone through Week 52.
DRUG	Methylprednisolone	Methylprednisolone 80 mg (or 1.5 mg/kg if \</=45 kg) IV will be administered as premedication prior to infusions.
DRUG	Acetaminophen/ Paracetamol	Acetaminophen 15 mg/kg (maximum dose 1000 mg) will be administered PO as premedication prior to infusions.
DRUG	Diphenhydramine Hydrochloride	Diphenhydramine HCl 0.5-1 mg/kg (maximum dose 50 mg) will be administered PO or IV as premedication prior to infusions.

Timeline

• Start date: 2023-03-29
• Primary completion: 2025-09-04
• Completion: 2026-09-04
• First posted: 2022-11-25
• Last updated: 2025-12-15

Locations

39 sites across 9 countries: United States, Belgium, Brazil, China, France, Italy, Japan, Poland, Spain

Regulatory

• FDA-regulated drug study