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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
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The purpose of this study is to evaluate the safety and efficacy of Obinutuzumab in inducing complete or partial remission of proteinuria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Primary Focal Segmental Glomerulosclerosis (FSGS) | Experimental | Subjects with immunosuppression-dependent or immunosuppression/treatment-resistant primary FSGS or contraindication/patient refusal to take high dose corticosteroids, will receive obinutuzumab 1 gram on day 1 and 1 gram on day 15, given intravenously and then an identical course at 6 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Obinutuzumab | Drug | 1g IV on day one and 1 g IV on day 15, followed by identical course at month 6 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Proteinuria | Measured using 24 hour urine collection reported in g/d | Baseline, 12 months, 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Remission Status at 12 Months | The number of subjects to reach either complete remission or partial remission at 12 months after infusion. Complete remission defined as proteinuria < 0.3g/24 hrs. and no more than 20% decline in eGFR. Partial remission defined as 50% reduction in proteinuria and proteinuria < 3.5 g/24hrs and no more than 20% decline in eGFR. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fernando Fervenza, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 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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| ID | Title | Description |
|---|---|---|
| FG000 | Obinutuzumab | Subjects will receive obinutuzumab intravenously at a dose of 1g on day one and 1g on day 15, followed by identical course at month 6. Obinutuzumab: Intravenously (IV) at a dose of 1g on day one and 1g on day 15, followed by identical course at month 6. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Primary Focal Segmental Glomerulosclerosis (FSGS) | Subjects with immunosuppression-dependent or immunosuppression/treatment-resistant primary FSGS or contraindication/patient refusal to take high dose corticosteroids, will receive obinutuzumab 1 gram on day 1 and 1 gram on day 15, given intravenously and then an identical course at 6 months. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Proteinuria | Measured using 24 hour urine collection reported in g/d | Posted | Median | Inter-Quartile Range | g/d | Baseline, 12 months, 24 months |
|
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Adverse events were collected from baseline to end of study for a total of approximately 2 years on all participants.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Obinutuzumab | Subjects will receive obinutuzumab intravenously at a dose of 1g on day one and 1g on day 15, followed by identical course at month 6. Obinutuzumab: Intravenously (IV) at a dose of 1g on day one and 1g on day 15, followed by identical course at month 6. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| suicidal ideation | Psychiatric disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Covid-19 | Infections and infestations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Fernando Fervenza | Mayo Clinic | 507-284-3479 | bendtsen.corbyn@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 5, 2025 | May 4, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| C543332 | obinutuzumab |
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| Change in Serum Albumin | Blood serum collected and reported in g/dL | Baseline, 12 months, 24 months |
| Serious Adverse Events (SAEs) | Number of subjects to experience serious adverse events including serious infection defined as severe UTI or pyelonephritis, pneumonias or other systemic infections requiring hospitalization | 24 months |
| Proteinuria at 18 Months | Measured using 24 hour urine collection reported in g/d | 18 months |
| Proteinuria at 24 Months | Measured using 24 hour urine collection reported in g/d | 24 months |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | Participants |
|
|
|
| Secondary | Remission Status at 12 Months | The number of subjects to reach either complete remission or partial remission at 12 months after infusion. Complete remission defined as proteinuria < 0.3g/24 hrs. and no more than 20% decline in eGFR. Partial remission defined as 50% reduction in proteinuria and proteinuria < 3.5 g/24hrs and no more than 20% decline in eGFR. | Posted | Count of Participants | Participants | 12 months |
|
|
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| Secondary | Change in Serum Albumin | Blood serum collected and reported in g/dL | Posted | Mean | Standard Deviation | g/dL | Baseline, 12 months, 24 months |
|
|
|
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| Secondary | Serious Adverse Events (SAEs) | Number of subjects to experience serious adverse events including serious infection defined as severe UTI or pyelonephritis, pneumonias or other systemic infections requiring hospitalization | Posted | Number | Serious Adverse Events | 24 months |
|
|
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| Secondary | Proteinuria at 18 Months | Measured using 24 hour urine collection reported in g/d | Posted | Median | Inter-Quartile Range | g/d | 18 months |
|
|
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| Secondary | Proteinuria at 24 Months | Measured using 24 hour urine collection reported in g/d | Posted | Median | Inter-Quartile Range | g/d | 24 months |
|
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|
| 0 |
| 20 |
| 2 |
| 20 |
| 20 |
| 20 |
| pseudo-seizures | Psychiatric disorders | Systematic Assessment |
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| follicular lymphoma | Blood and lymphatic system disorders | Systematic Assessment |
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| Worsening Anemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Myelofibrosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Shortness of breath | General disorders | Systematic Assessment |
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| Congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Nausea | General disorders | Systematic Assessment |
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| Vomiting | General disorders | Systematic Assessment |
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| Mouth Ulcers | General disorders | Systematic Assessment |
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| Fever | General disorders | Systematic Assessment |
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| Bradycardia during infusion | General disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Blurred vision | Eye disorders | Systematic Assessment |
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| Hair loss | General disorders | Systematic Assessment |
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| Brittle fingernails | General disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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| Lightheadedness | General disorders | Systematic Assessment |
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| Joint Stiffness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Shingles | Infections and infestations | Systematic Assessment |
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| Hypertension during infusion | General disorders | Systematic Assessment |
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| Body itching | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Increased blood pressure | Vascular disorders | Systematic Assessment |
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| Forgetfulness | Nervous system disorders | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | Systematic Assessment |
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| Physical weakness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Unsteady gait | Nervous system disorders | Systematic Assessment |
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| Dysphonia | General disorders | Systematic Assessment |
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| Bradycardia | Cardiac disorders | Systematic Assessment |
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| Chills | General disorders | Systematic Assessment |
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| Hypokalemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Weight loss | Metabolism and nutrition disorders | Systematic Assessment |
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| Eye swelling | Eye disorders | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Dysuria | Renal and urinary disorders | Systematic Assessment |
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| Muscle Soreness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Sore throat | General disorders | Systematic Assessment |
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| Teeth Soreness | General disorders | Systematic Assessment |
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| Tachycardia | Cardiac disorders | Systematic Assessment |
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| Chest tightness | General disorders | Systematic Assessment |
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| Increased anxiety | Social circumstances | Systematic Assessment |
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| Restless legs | General disorders | Systematic Assessment |
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| Facial flushing | General disorders | Systematic Assessment |
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| Stomach pain | General disorders | Systematic Assessment |
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| Pneumonia | Infections and infestations | Systematic Assessment |
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| Swollen lymph nodes | Blood and lymphatic system disorders | Systematic Assessment |
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| Thrush | Infections and infestations | Systematic Assessment |
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| Upper respiratory infection | Infections and infestations | Systematic Assessment |
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| Night sweats | General disorders | Systematic Assessment |
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| Body numbness | General disorders | Systematic Assessment |
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| Flu like symptoms | Infections and infestations | Systematic Assessment |
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| Fluid overload | Renal and urinary disorders | Systematic Assessment |
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| Hip pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Influenza A | Infections and infestations | Systematic Assessment |
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