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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: Active Phase 3 study of Childhood Idiopathic Nephrotic Syndrome, sponsored by Hoffmann-La Roche.
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, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (89% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
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 |
What the registry record for NCT05627557 still lists
NCT05627557 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 85 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (89% lower).
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 names 20 study sites across 10 states, led by 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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05627557's enrollment target sits among peer trials
85 1748th of 2000 higher than 252 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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