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A Study to Evaluate the Efficacy and Safety of Obinutuzumab Versus MMF in Participants With Childhood Onset Idiopathic Nephrotic Syndrome
NCT05627557 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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 758 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05627557 reports 20 study locations spanning 10 distinct geographic areas — top geographies include Other, Florida, São Paulo. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05627557?
The interventions under investigation include: Obinutuzumab (DRUG), Prednisone (DRUG), Methylprednisolone (DRUG), MMF (DRUG), Acetaminophen/ Paracetamol (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05627557?
This trial is sponsored by Hoffmann-La Roche, which has 758 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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