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NCT05627557 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Efficacy and Safety of Obinutuzumab Versus MMF in Participants With Childhood Onset Idiopathic Nephrotic Syndrome
A Phase 3 study of Childhood Idiopathic Nephrotic Syndrome, sponsored by Hoffmann-La Roche.
- Active
- Registry status
- Phase 3
- Development phase
- 85
- Enrollment target
- 20
- Study locations
NCT05627557 is a Phase 3 study of Childhood Idiopathic Nephrotic Syndrome that is active but no longer recruiting, run by Hoffmann-La Roche. The registered enrollment target is 85 participants. The trial reports 20 study locations across 10 states.
The verdict
NCT05627557, a Phase 3 study of Childhood Idiopathic Nephrotic Syndrome, is active but no longer recruiting, sponsored by Hoffmann-La Roche.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 85 participants
- Enrollment target
- 20
- Study locations
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).
Conditions Studied
Interventions
- DRUG Obinutuzumab
- DRUG Prednisone
- DRUG Methylprednisolone
- DRUG MMF
- DRUG Acetaminophen/ Paracetamol
Study Locations (20)
Other
- UZ Gent - Ghent
- Peking University First Hospital - Beijing
- The First Affiliated Hospital of Sun Yat-sen University - Guangzhou
- The children's hospital , Zhejiang university school of medicine - Hangzhou
- Tongji Hospital Tongji Medical College Huazhong University of Science and Technology - Wuhan
- Xi'an Children's Hospital - Xi'an
- Henan Children's Hospital Zhengzhou Children's Hospital - Zhengzhou
Florida
- Memorial Healthcare System - Hollywood
- Nicklaus Children's Hospital - Miami
- Nemours Children's Hospital - Orlando
- University of South Florida - Tampa
São Paulo
- Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto Hospital de Base - PPDS - São José do Rio Preto
- Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo - São Paulo
California
- Lucile Packard Children's Hospital - Stanford - Palo Alto
Georgia
- Children's Healthcare of Atlanta Center for Advanced Pediatrics - Atlanta
New Jersey
- Hackensack University Medical Center - Hackensack
North Carolina
- Levine Children's Hospital - Charlotte
Utah
- University of Utah - Primary Children's Hospital - PPDS - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 85 participants |
| Start Date | 2023-03-29 |
| Est. Completion | 2026-09-04 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05627557
The ClinicalTrials.gov registry entry for NCT05627557 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 85 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Childhood Idiopathic Nephrotic Syndrome appearing as the primary indexed condition, and to 5 interventions - of which Obinutuzumab is the first listed.
NCT05627557 reports 20 study locations spanning 10 distinct geographic areas - top geographies include Other, Florida, São Paulo.
Frequently Asked Questions
What is clinical trial NCT05627557 about?
NCT05627557 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of Obinutuzumab Versus MMF in Participants With Childhood Onset Idiopathic Nephrotic Syndrome". 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...
What is the current status of trial NCT05627557?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 85 participants. The study started on 2023-03-29. Estimated completion is 2026-09-04.
What conditions does trial NCT05627557 study?
This clinical trial studies the following conditions: Childhood Idiopathic Nephrotic Syndrome.
What interventions are being tested in trial NCT05627557?
The interventions under investigation include: Obinutuzumab (DRUG), Prednisone (DRUG), Methylprednisolone (DRUG), MMF (DRUG), Acetaminophen/ Paracetamol (DRUG).
Who is sponsoring clinical trial NCT05627557?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05627557 being conducted?
This trial has 20 study locations across California, Florida, Georgia, New Jersey, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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