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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-000369-42 | EudraCT Number | ||
| 2023-505140-19-00 | Other Identifier | EU CT Number |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Obinutuzumab (Group A) | Experimental | Participants in Group A will receive obinutuzumab 1000 milligrams (mg) (or 20 mg/ kilogram [kg] for participants <45 kg) administered by intravenous (IV) infusion on Days 1, 15, 168 (Week 24), and 182 (Week 26). |
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| MMF (Group B) | Active Comparator | Participants in Group B will receive oral MMF 600 mg/m^2 twice a day (BID) (target 1200 mg/m2/day in divided doses, maximum 2 g/day) to Week 52. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Obinutuzumab | Drug | Obinutuzumab will be administered as per schedule specified in the respective arm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with Sustained Complete Remission at 1 year | At Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Relapse-free Survival (RFS) | At Week 52 | |
| Probability of RFS at Week 52 | At Week 52 | |
| Cumulative Corticosteroid Dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lucile Packard Children's Hospital - Stanford | Palo Alto | California | 94304-1601 | United States | ||
| Memorial Healthcare System |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39513526 | Derived | Larkins NG, Hahn D, Liu ID, Willis NS, Craig JC, Hodson EM. Non-corticosteroid immunosuppressive medications for steroid-sensitive nephrotic syndrome in children. Cochrane Database Syst Rev. 2024 Nov 8;11(11):CD002290. doi: 10.1002/14651858.CD002290.pub6. | |
| 37678236 | Derived | Dossier C, Bonneric S, Baudouin V, Kwon T, Prim B, Cambier A, Couderc A, Moreau C, Deschenes G, Hogan J. Obinutuzumab in Frequently Relapsing and Steroid-Dependent Nephrotic Syndrome in Children. Clin J Am Soc Nephrol. 2023 Dec 1;18(12):1555-1562. doi: 10.2215/CJN.0000000000000288. Epub 2023 Sep 6. |
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For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
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| MMF | Drug | MMF will be administered as per schedule specified in the respective arm. |
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| Prednisone | Drug | Participants taking prednisone or equivalent at randomization will follow a guided tapering schedule to reach the goal of 0mg/day by Weeks 4-6 (and no later than Week 8 following randomization and continue without prednisone through Week 52. |
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| Methylprednisolone | Drug | Methylprednisolone 80 mg (or 1.5 mg/kg if \ |
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| Acetaminophen/ Paracetamol | Drug | Acetaminophen 15 mg/kg (maximum dose 1000 mg) will be administered PO as premedication prior to infusions. |
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| Diphenhydramine Hydrochloride | Drug | Diphenhydramine HCl 0.5-1 mg/kg (maximum dose 50 mg) will be administered PO or IV as premedication prior to infusions. |
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| At Week 52 |
| Number of Relapses | At Week 52 |
| Percentage of Participants Experiencing Edema Associated Relapse | At Week 52 |
| Percentage of Participants with Sustained Complete Remission | This outcome measure will be assessed at primary analysis | Week 52 to Week 76 |
| Mean Change in "General Fatigue" Domain of Pediatric Quality of Life Inventory (PedsQL) Multidimensional Fatigue Scale Total Score | Baseline to Week 52 |
| Mean Change in "Physical Functioning" Domain of PedsQL Quality of Life Inventory | Baseline to Week 52 |
| Mean Change in Cure Glomerulonephropathy (CureGN) Edema Scale | Baseline to Week 52 |
| Percentage of Participants with Adverse Events (AEs) | Baseline to Week 52 |
| Serum Concentrations of Obinutuzumab | At Days 1, 15 28, 84, 168, 182, 224, 364, and at Early Study Discontinuation Visit (unscheduled visit at the time of discontinuation from study, any time between Day 1 and Day 364) |
| Percentage of Participants Achieving B Cell Depletion Highly Sensitive Flow Cytometry (HSFC) | At Days 1, 15, 28, 84, 168, 224, 364, and at Early Study Discontinuation Visit (unscheduled visit at the time of discontinuation from study, any time between Day 1 and Day 364) |
| Total Peripheral B Cell and B Cell Subsets (e.g., Memory B Cells) Counts and Change from Baseline | At Days 1, 15, 28, 84, 168, 224, 364, and at Early Study Discontinuation Visit (unscheduled visit at the time of discontinuation from study, any time between Day 1 and Day 364) |
| Hollywood |
| Florida |
| 33021 |
| United States |
| Nicklaus Children's Hospital | Miami | Florida | 33155-3009 | United States |
| Nemours Children's Hospital | Orlando | Florida | 32827-7884 | United States |
| University of South Florida | Tampa | Florida | 33606-3475 | United States |
| Children's Healthcare of Atlanta Center for Advanced Pediatrics | Atlanta | Georgia | 30329-2309 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601-1915 | United States |
| Levine Children's Hospital | Charlotte | North Carolina | 28203-5866 | 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 |
| UZ Gent | Ghent | 9000 | Belgium |
| Irmandade Da Santa Casa de Misericordia de Porto Alegre | Porto Alegre | Rio Grande do Sul | 90020-090 | Brazil |
| 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 |
| Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo | São Paulo | São Paulo | 05403-000 | Brazil |
| Peking University First Hospital | Beijing | 102627 | China |
| The First Affiliated Hospital of Sun Yat-sen University | Guangzhou | 510080 | China |
| The children's hospital , Zhejiang university school of medicine | Hangzhou | 310003 | China |
| Tongji Hospital Tongji Medical College Huazhong University of Science and Technology | Wuhan | 430040 | China |
| Xi'an Children's Hospital | Xi'an | 710003 | China |
| Henan Children's Hospital Zhengzhou Children's Hospital | Zhengzhou | 450018 | China |
| Chu Toulouse | Toulouse | Haute-Garonne | 31300 | France |
| Hopital Femme Mere Enfants | Bron | 69500 | France |
| Hopital Henri Mondor | Créteil | 94010 | France |
| Hopital Robert Debre | Paris | 75935 | France |
| Istituto G Gaslini Ospedale Pediatrico IRCCS - INCIPIT - PIN | Genoa | Liguria | 16147 | Italy |
| Ospedale Infantile Regina Margherita - INCIPIT - PIN | Turin | Piedmont | 10126 | Italy |
| Tokyo Metropolitan Children's Medical Center | Fuchu-Shi | 183-0042 | Japan |
| Hokkaido University Hospital | Hokkaido | 060-8648 | Japan |
| Hyogo prefectural Kobe Children's Hospital | Hyogoken | 6500047 | Japan |
| Kobe University Hospital | Kobe | 650-0017 | Japan |
| Shiga University Of Medical Science Hospital | Ōtsu | 520-2192 | Japan |
| Kitasato University Hospital | Sagamihara-Shi | 252-0329 | Japan |
| Dokkyo Medical University Hospital | Shimotsuga-Gun | 321-0293 | Japan |
| National Center for Child Health and Development | Tokyo | 157-8535 | Japan |
| Yokohama City University Medical Center | Yokohama | 232-0024 | Japan |
| Uniwersyteckie Centrum Kliniczne | Gdansk | Poland |
| Dzieciecy Szpital Kliniczny UCK WUM | Warsaw | 02-091 | Poland |
| Hospital Sant Joan de Deu - PIN | Espluges de Llobregat | Barcelona | 08950 | Spain |
| Hospital Universitario Cruces | Barakaldo | Vizcaya | 48903 | Spain |
| ID | Term |
|---|---|
| D009404 | Nephrotic Syndrome |
| ID | Term |
|---|---|
| D009401 | Nephrosis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C543332 | obinutuzumab |
| D011241 | Prednisone |
| D008775 | Methylprednisolone |
| D000082 | Acetaminophen |
| D004155 | Diphenhydramine |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D005021 | Ethylamines |
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
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