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New hope for kids with kidney disease: drug may cut relapses and steroids

NCT ID NCT05627557

Disease control Sponsor: Hoffmann-La Roche Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a drug called obinutuzumab against a standard treatment (MMF) in children and young adults with a kidney condition that causes frequent relapses. The goal is to see if obinutuzumab can keep the disease in remission longer and reduce the need for steroids. About 85 participants aged 2 to 25 will be randomly assigned to one of the two treatments.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

85 people

The number who actually took part.

Started

Mar 2023

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

2 to 25 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Diagnosis of frequently relapsing nephrotic syndrome (FRNS) or steroid dependent nephrotic syndrome (SDNS) before the age of 18 years * Must be in complete remission defined by the absence of edema, UPCR \<= 0.2 g/g at screening and have three consecutive daily urine dipstick readings of trace or negative for protein within the week prior to randomization * Must have had at least one relapse in the 6 months prior to screening, after discontinuation of or while receiving oral corticosteroids and/or immunosuppressive therapy to prevent relapses * Participants having received cyclophosphamide in the 6 months prior to randomization must have experienced at least 1 relapse subsequent to cyclophosphamide discontinuation * Estimated glomerular filtration rate (eGFR) within normal range for age * For females of childbearing potential: participants who agree to remain abstinent (refrain from heterosexual intercourse) or use highly effective contraception, during the treatment period and for 18 months after the final dose of obinutuzumab and for 6 weeks after the final dose of MMF * For males: participants who agree to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agree to refrain from donating sperm during the treatment period and for 90 days after the final dose of MMF Exclusion Criteria: * Secondary nephrotic syndrome * History of steroid resistant nephrotic syndrome * History of genetic defects known to directly cause nephrotic syndrome * Treatment with other immunosuppressive medications to prevent relapse, other than MMF or oral corticosteroids within 2 months prior to randomization * Pregnancy or breastfeeding or intending to become pregnant during the study or within 18 months after the final dose of obinutuzumab, or within 6 weeks after the final dose of MMF * Females of childbearing potential, including those who have had a tubal ligation, must have a negative serum pregnancy test result within 28 days prior to initiation of study treatment and a negative urine pregnancy test at Day 1, prior to randomization * History of organ or bone marrow transplant * Participation in another therapeutic trial within 30 days of enrollment or 5 half-lives of the investigational drug * Intolerance or contraindication to study therapies * Participants demonstrating prior treatment failure to MMF as defined by two or more relapses in any 6-month period of time while receiving MMF for at least a 6-month duration * Participants in the judgment of the investigator likely to require systemic corticosteroids for reasons other than idiopathic nephrotic syndrome during the study * Active infection of any kind or any major episode of infection requiring hospitalization or treatment with IV anti-infective medications within 4 weeks prior to screening, or completion of oral anti-infectives within 2 weeks prior to randomization * History of or currently active primary or secondary immunodeficiency, including known history of human immunodeficiency virus (HIV) infection and other severe Immunodeficiency blood disorders * History of progressive multifocal leukoencephalopathy * History of or current cancer, including solid tumors, hematological malignancies, and carcinoma in situ within the past 5 years * Major surgery requiring hospitalization during the 4 weeks prior to screening or during screening * High risk for clinically significant bleeding or any condition requiring plasmapheresis, intravenous immunoglobulin, or acute blood product transfusions * Evidence of any significant or uncontrolled concomitant disease that, in the investigator's judgment, would preclude participant's participation, including but not limited to nervous system, respiratory, cardiac, hepatic, endocrine, malignant, or gastrointestinal disorders * Currently active alcohol or drug abuse or history of alcohol or drug abuse

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Conditions

The condition(s) this trial relates to.

idiopathic nephrotic syndrome nephrotic syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Childhood idiopathic nephrotic syndrome

Contacts and locations

Locations

  • Children's Healthcare of Atlanta Center for Advanced Pediatrics

    Atlanta, Georgia, 30329-2309, United States

  • Chu Toulouse

    Toulouse, Haute-Garonne, 31300, France

  • Dokkyo Medical University Hospital

    Shimotsuga-Gun, 321-0293, Japan

  • Dzieciecy Szpital Kliniczny UCK WUM

    Warsaw, 02-091, Poland

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

    São José do Rio Preto, São Paulo, 15090-000, Brazil

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601-1915, United States

  • Henan Children's Hospital Zhengzhou Children's Hospital

    Zhengzhou, 450018, China

  • Hokkaido University Hospital

    Hokkaido, 060-8648, Japan

  • Hopital Femme Mere Enfants

    Bron, 69500, France

  • Hopital Henri Mondor

    Créteil, 94010, France

  • Hopital Robert Debre

    Paris, 75935, France

  • Hospital Sant Joan de Deu - PIN

    Espluges de Llobregat, Barcelona, 08950, Spain

  • Hospital Universitario Cruces

    Barakaldo, Vizcaya, 48903, Spain

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

    São Paulo, São Paulo, 05403-000, Brazil

  • Hyogo prefectural Kobe Children's Hospital

    Hyogoken, 6500047, Japan

  • Irmandade Da Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90020-090, Brazil

  • Istituto G Gaslini Ospedale Pediatrico IRCCS - INCIPIT - PIN

    Genoa, Liguria, 16147, Italy

  • Kitasato University Hospital

    Sagamihara-Shi, 252-0329, Japan

  • Kobe University Hospital

    Kobe, 650-0017, Japan

  • Levine Children's Hospital

    Charlotte, North Carolina, 28203-5866, United States

  • Lucile Packard Children's Hospital - Stanford

    Palo Alto, California, 94304-1601, United States

  • Memorial Healthcare System

    Hollywood, Florida, 33021, United States

  • National Center for Child Health and Development

    Tokyo, 157-8535, Japan

  • Nemours Children's Hospital

    Orlando, Florida, 32827-7884, United States

  • Nicklaus Children's Hospital

    Miami, Florida, 33155-3009, United States

  • Ospedale Infantile Regina Margherita - INCIPIT - PIN

    Turin, Piedmont, 10126, Italy

  • Peking University First Hospital

    Beijing, 102627, China

  • Shiga University Of Medical Science Hospital

    Ōtsu, 520-2192, Japan

  • The First Affiliated Hospital of Sun Yat-sen University

    Guangzhou, 510080, China

  • The children's hospital , Zhejiang university school of medicine

    Hangzhou, 310003, China

  • Tokyo Metropolitan Children's Medical Center

    Fuchu-Shi, 183-0042, Japan

  • Tongji Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, 430040, China

  • UZ Gent

    Ghent, 9000, Belgium

  • University of South Florida

    Tampa, Florida, 33606-3475, United States

  • University of Utah - Primary Children's Hospital - PPDS

    Salt Lake City, Utah, 84113-1103, United States

  • University of Virginia Health System

    Charlottesville, Virginia, 22903, United States

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, Poland

  • Xi'an Children's Hospital

    Xi'an, 710003, China

  • Yokohama City University Medical Center

    Yokohama, 232-0024, Japan