Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT05627557
PHASE3

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

Sponsor: Hoffmann-La Roche

View on ClinicalTrials.gov

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).

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

Key Details

Gender

All

Age Range

2 Years - 25 Years

Study Type

INTERVENTIONAL

Enrollment

85

Start Date

2023-03-29

Completion Date

2026-09-04

Last Updated

2025-12-15

Healthy Volunteers

No

Interventions

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.

Locations (39)

Lucile Packard Children's Hospital - Stanford

Palo Alto, California, United States

Memorial Healthcare System

Hollywood, Florida, United States

Nicklaus Children's Hospital

Miami, Florida, United States

Nemours Children's Hospital

Orlando, Florida, United States

University of South Florida

Tampa, Florida, United States

Children's Healthcare of Atlanta Center for Advanced Pediatrics

Atlanta, Georgia, United States

Hackensack University Medical Center

Hackensack, New Jersey, United States

Levine Children's Hospital

Charlotte, North Carolina, United States

University of Utah - Primary Children's Hospital - PPDS

Salt Lake City, Utah, United States

University of Virginia Health System

Charlottesville, Virginia, United States

UZ Gent

Ghent, Belgium

Irmandade Da Santa Casa de Misericordia de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto Hospital de Base - PPDS

São José do Rio Preto, São Paulo, Brazil

Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo

São Paulo, São Paulo, Brazil

Peking University First Hospital

Beijing, China

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, China

The children's hospital , Zhejiang university school of medicine

Hangzhou, China

Tongji Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, China

Xi'an Children's Hospital

Xi'an, China

Henan Children's Hospital Zhengzhou Children's Hospital

Zhengzhou, China

Chu Toulouse

Toulouse, Haute-Garonne, France

Hopital Femme Mere Enfants

Bron, France

Hopital Henri Mondor

Créteil, France

Hopital Robert Debre

Paris, France

Istituto G Gaslini Ospedale Pediatrico IRCCS - INCIPIT - PIN

Genoa, Liguria, Italy

Ospedale Infantile Regina Margherita - INCIPIT - PIN

Turin, Piedmont, Italy

Tokyo Metropolitan Children's Medical Center

Fuchu-Shi, Japan

Hokkaido University Hospital

Hokkaido, Japan

Hyogo prefectural Kobe Children's Hospital

Hyogoken, Japan

Kobe University Hospital

Kobe, Japan

Shiga University Of Medical Science Hospital

Ōtsu, Japan

Kitasato University Hospital

Sagamihara-Shi, Japan

Dokkyo Medical University Hospital

Shimotsuga-Gun, Japan

National Center for Child Health and Development

Tokyo, Japan

Yokohama City University Medical Center

Yokohama, Japan

Uniwersyteckie Centrum Kliniczne

Gdansk, Poland

Dzieciecy Szpital Kliniczny UCK WUM

Warsaw, Poland

Hospital Sant Joan de Deu - PIN

Espluges de Llobregat, Barcelona, Spain

Hospital Universitario Cruces

Barakaldo, Vizcaya, Spain