A Study to Evaluate the Efficacy and Safety of Obinutuzumab Versus MMF in Participants With Childhood Onset Idiopathic Nephrotic Syndrome
Condition(s) studied
Investigational drug(s) / intervention(s)
Obinutuzumab: Obinutuzumab will be administered as per schedule specified in the respective arm.
MMF: MMF will be administered as per schedule specified in the respective arm.
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.
Methylprednisolone: Methylprednisolone 80 mg (or 1.5 mg/kg if \</=45 kg) IV will be administered as premedication prior to infusions.
Acetaminophen/ Paracetamol: Acetaminophen 15 mg/kg (maximum dose 1000 mg) will be administered PO as premedication prior to infusions.
Diphenhydramine Hydrochloride: Diphenhydramine HCl 0.5-1 mg/kg (maximum dose 50 mg) will be administered PO or IV as premedication prior to infusions.
Study 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).
Eligibility
Primary outcome measure(s)
- Percentage of Participants with Sustained Complete Remission at 1 year — At Week 52
Trial sites (39)
| Facility | City | Region | Status |
|---|---|---|---|
| Lucile Packard Children's Hospital - Stanford | Palo Alto | California | |
| Memorial Healthcare System | Hollywood | Florida | |
| Nicklaus Children's Hospital | Miami | Florida | |
| Nemours Children's Hospital | Orlando | Florida | |
| University of South Florida | Tampa | Florida | |
| Children's Healthcare of Atlanta Center for Advanced Pediatrics | Atlanta | Georgia | |
| Hackensack University Medical Center | Hackensack | New Jersey | |
| Levine Children's Hospital | Charlotte | North Carolina | |
| University of Utah - Primary Children's Hospital - PPDS | Salt Lake City | Utah | |
| University of Virginia Health System | Charlottesville | Virginia | |
| UZ Gent | Ghent | Belgium | |
| Irmandade Da Santa Casa de Misericordia de Porto Alegre | Porto Alegre | Rio Grande do Sul | |
| Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto Hospital de Base - PPDS | São José do Rio Preto | São Paulo | |
| Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo | São Paulo | São Paulo | |
| 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 | |
| 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 | |
| Ospedale Infantile Regina Margherita - INCIPIT - PIN | Turin | Piedmont | |
| 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 | |
| Hospital Universitario Cruces | Barakaldo | Vizcaya |
On this site
📄 Deltasone (prednisone) drug profile →More Hoffmann-La Roche trials in Italy
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05627557 on ClinicalTrials.gov ↗ ← All trials in Italy