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

ClinicalTrials.gov ID: NCT05627557

Public ClinicalTrials.gov record NCT05627557. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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).

Study identification

NCT ID: NCT05627557
Recruitment status: Active, not recruiting
Study type: Interventional
Phase: Phase 3
Lead sponsor: Hoffmann-La Roche; Industry
Enrollment: 85 participants

Conditions and interventions

Conditions

Childhood Idiopathic Nephrotic Syndrome

Interventions

Drug

Eligibility (public fields only)

Age range: 2 Years to 25 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Mar 28, 2023
Primary completion: Sep 3, 2025
Completion: Sep 3, 2026
Last update posted: Dec 14, 2025

2023 – 2026

United States locations

U.S. sites: 10
U.S. states: 7
U.S. cities: 10

Facility	City	State	ZIP	Site status
Lucile Packard Children's Hospital - Stanford	Palo Alto	California	94304-1601	—
Memorial Healthcare System	Hollywood	Florida	33021	—
Nicklaus Children's Hospital	Miami	Florida	33155-3009	—
Nemours Children's Hospital	Orlando	Florida	32827-7884	—
University of South Florida	Tampa	Florida	33606-3475	—
Children's Healthcare of Atlanta Center for Advanced Pediatrics	Atlanta	Georgia	30329-2309	—
Hackensack University Medical Center	Hackensack	New Jersey	07601-1915	—
Levine Children's Hospital	Charlotte	North Carolina	28203-5866	—
University of Utah - Primary Children's Hospital - PPDS	Salt Lake City	Utah	84113-1103	—
University of Virginia Health System	Charlottesville	Virginia	22903	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 29 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT05627557, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Dec 14, 2025 · Synced Aug 3, 2026

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The complete protocol, eligibility criteria, and contact information for NCT05627557 live on ClinicalTrials.gov.

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