Obinutuzumab in Frequently Relapsing and Steroid-Dependent Nephrotic Syndrome in Children.
Claire Dossier, Stéphanie Bonneric, Véronique Baudouin...
https://pubmed.ncbi.nlm.nih.gov/37678236Actively Recruiting
Phase 2
Age: 5Years - 17Years
All Genders
ID05039619
A Phase II, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Obinutuzumab in Adolescents With Active Class III or IV Lupus Nephritis and Safety in Pediatric Participants
Led by Hoffmann-La Roche · Updated on 2026-06-03
40
Participants Needed
42
Research Sites
104 weeks
Total Duration
On this page
Sponsors
H
Hoffmann-La Roche
Lead Sponsor
G
Genentech, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, effectiveness, and how the body processes obinutuzumab in children and adolescents with active Class III or IV lupus nephritis, a serious kidney condition related to lupus. This Phase II, randomized, double-blind, placebo-controlled study focuses on adolescents aged 12 to less than 18 years with biopsy-confirmed proliferative lupus nephritis, and also assesses open-label safety and drug processing in younger children aged 5 to less than 12 years. Participants will receive intravenous infusions of obinutuzumab at specific times: Day 1, Day 14, Week 24, Week 26, and Week 52. Adolescents weighing 45 kg or more get a 1000 mg dose, while those under 45 kg receive a weight-based dose of 20 mg/kg. Younger children aged 5 to less than 12 years also receive 1000 mg infusions on the same schedule. A placebo group for adolescents receives matching infusions without the active drug. Additional medications like mycophenolate mofetil, acetaminophen, diphenhydramine, methylprednisolone, and prednisone are also used as part of the treatment and pre-medication. During the study, participants will be closely monitored through various assessments including kidney function tests, proteinuria measurement, disease activity indices, quality of life questionnaires, and tracking of side effects up to Week 76. Researchers will evaluate the percentage of participants achieving complete or partial renal response, prednisone tapering success, drug levels in the blood, immune cell depletion, and adverse effects. The total participation time spans over 76 weeks, allowing thorough evaluation of treatment outcomes and safety.
CONDITIONS
Brief Title
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Obinutuzumab in Adolescents With Active Class III or IV Lupus Nephritis and the Safety and PK of Obinutuzumab in Pediatric Participants
Who Can Participate
Age: 5Years - 17Years
All Genders
Eligibility Criteria
You may qualify if you...
- Participants aged 12 to less than 18 years at randomization
- Participants aged 5 to less than 12 years at randomization once recruitment opens
- Biopsy-confirmed active Class III or IV lupus nephritis within 12 months prior to or during screening
- Class V disease may be present with Class III or IV, but isolated Class V disease is not eligible
- Diagnosis of systemic lupus erythematosus according to SLICC 2012 criteria
- Significant proteinuria with urine protein to creatinine ratio above 0.5 at screening
- Received at least one dose of pulse-range IV methylprednisolone or equivalent for current active lupus nephritis episode within 12 months prior to or during screening
You will not qualify if you...
- Severe active central nervous system lupus, including retinitis, uncontrolled seizures, confusional state, myelitis, stroke, cerebellar ataxia, or dementia
- More than 50% sclerosis of glomeruli on renal biopsy
- Purely chronic Class III(c) or IV(c) disease without active lesions on biopsy
- Presence of rapidly progressive glomerulonephritis
- Pure Class V lupus nephritis
- Intolerance or contraindication to study therapies
- Active infection or recent serious infection requiring hospitalization or IV treatment
- History or active primary or secondary immunodeficiency, including HIV
- History of serious recurrent or chronic infections
- History or current cancer within past 5 years except certain skin cancers fully treated
- Significant uncontrolled medical conditions that may interfere with participation
- Current or recent alcohol or drug abuse
AI-Screening
AI-Powered Screening
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 52 weeks
Participants receive intravenous infusions of obinutuzumab or placebo on Day 1, Day 14, Week 24, Week 26, and Week 52. Participants also take oral Mycophenolate Mofetil daily from baseline and corticosteroids with a guided taper by Week 24.
5 infusion visits plus regular oral medication at home
Follow-up
Duration - Up to 24 weeks after treatment
Participants are monitored for safety, efficacy, and pharmacokinetics outcomes up to Week 76 after treatment.
Periodic visits for assessments up to Week 76
Trial Site Locations
Total: 42 locations
1
Loma Linda University health
Loma Linda, California, United States, 92354
Actively Recruiting
2
UCSF Benioff Childrens Hospital
San Francisco, California, United States, 94158
Actively Recruiting
3
Children's Hospital Colorado, Anchutz Medical Campus
Aurora, Colorado, United States, 80045
Actively Recruiting
4
Emory Children's Center
Atlanta, Georgia, United States, 30322
Actively Recruiting
5
Indiana University Health University Hospital
Indianapolis, Indiana, United States, 46202
Actively Recruiting
6
Louisiana State University
Shreveport, Louisiana, United States, 71103
Actively Recruiting
7
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Withdrawn
8
Cohen Children's Medical Center of New York
Queens, New York, United States, 11042
Actively Recruiting
9
Cincinnati Childrens Hospital
Cincinnati, Ohio, United States, 45229
Actively Recruiting
10
Chldren?s Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Withdrawn
11
Texas Arthritis Center
El Paso, Texas, United States, 79902
Withdrawn
12
Ser Servicos Especializados Em Reumatologia
Salvador, Estado de Bahia, Brazil, 40150-150
Actively Recruiting
13
Centro de Pesquisa São Lucas
Campinas, São Paulo, Brazil, 13060-904
Actively Recruiting
14
Hospital das Clinicas - FMUSP
São Paulo, São Paulo, Brazil, 05403-000
Actively Recruiting
15
Universidade Federal de Sao Paulo - UNIFES
São Paulo, Brazil, 04024-002
Active, Not Recruiting
16
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Actively Recruiting
17
Hospital Sainte-Justine
Montreal, Quebec, Canada, H3T 1C5
Actively Recruiting
18
CH de Bicêtre
Le Kremlin-Bicêtre, France, 94275
Actively Recruiting
19
Hôpital Robert Debré
Paris, France, 75019
Actively Recruiting
20
Hop Necker Enfants Malades
Paris, France, 75743
Actively Recruiting
21
CHU de Toulouse - Hôpital des Enfants
Toulouse, France, 31000
Actively Recruiting
22
Ospedale Pediatrico Bambino Gesu
Rome, Lazio, Italy, 00165
Actively Recruiting
23
IRCCS G. Gaslini
Genoa, Liguria, Italy, 16148
Actively Recruiting
24
Clinica Pediatrica II De Marchi
Milan, Lombardy, Italy, 20122
Actively Recruiting
25
CREA Hospital Mexico Americano
Guadalajara, Jalisco, Mexico, 44620
Actively Recruiting
26
Clinstile S.A de C.V.
Mexico City, Mexico CITY (federal District), Mexico, 06700
Actively Recruiting
27
Hospital Universitario Dr. Jose Eleuterio Gonzalez
Monterrey, Nuevo León, Mexico, 64460
Actively Recruiting
28
Instituto de Ginecología y Reproducción
Lima, Peru
Active, Not Recruiting
29
Clinica El Golf
San Isidro, Peru, L27 Lima
Active, Not Recruiting
30
Uniwersyteckie Centrum Kliniczne
Gdansk, Poland, 80-294
Actively Recruiting
31
Szpital Specjalistyczny dla Dzieci i Doroslych
Torun, Poland, 87-100
Withdrawn
32
Saint-Petersburg State
St-peterburg, Sankt-Peterburg, Russia, 194100
Withdrawn
33
Red Cross War Memorial Children?s Hospital
Cape Town, South Africa, 7700
Withdrawn
34
Groote Schuur Hospital
Cape Town, South Africa, 7925
Withdrawn
35
Panaroma Medical Center
Panorama, South Africa, 7500
Actively Recruiting
36
Hospital Sant Joan De Deu
Esplugas de Llobregat, Barcelona, Spain, 08950
Actively Recruiting
37
Hospital Ramon y Cajal
Madrid, Spain, 28034
Actively Recruiting
38
Hospital de La Paz
Madrid, Spain, 28046
Actively Recruiting
39
Hospital Universitario la Fe: Servicio de Reumatologia Pediatrica
Valencia, Spain, 46026
Actively Recruiting
40
Royal Hospital For Children
Glasgow, United Kingdom, G51 4TF
Withdrawn
41
Alder Hey Childrens Hospital
Liverpool, United Kingdom, L12 2AP
Actively Recruiting
42
Great Ormond Street Hospital for Children
London, United Kingdom, WC1N 3JH
Actively Recruiting
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Research Team
R
Reference Study ID Number: WA42985 https://forpatients.roche.com/
F
Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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