Obinutuzumab in Treatment of Fibrillary Glomerulonephritis
NCT ID: NCT06295770
Last Updated: 2025-04-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
20 participants
INTERVENTIONAL
2024-06-24
2026-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Obinutuzumab in Treatment of Fibrillary Glomerulonephritis
Patients with biopsy proven fibrillary GN who have \>1 gram/24 hour of proteinuria and eGFR ≥ 20 ml/min/BSA will be treated with Obinutuzumab.
Obinutuzumab
Obinutuzumab 1g IV on day one and 1 g IV on day 15, followed by identical course at month 6.
Interventions
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Obinutuzumab
Obinutuzumab 1g IV on day one and 1 g IV on day 15, followed by identical course at month 6.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Biopsy proven fibrillary glomerulonephritis
* Proteinuria \> 1.0 g/24hrs prior to initiation of immunosuppressive therapy
* eGFR ≥ 20 ml/min/BSA
Exclusion Criteria
* Presence of a secondary pathology on biopsy (e.g. diabetic nephropathy)
* Hepatitis B, C or HIV positive
* Pregnant or breast-feeding
* Active infection
* Kidney transplant
* Anemia with Hgb \< 8.0 g/dL
* Thrombocytopenia with platelet count \< 100'000
* Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complication
* Patients who have received cyclophosphamide in the last 6 months
* Patients who have received ACTH and/or mycophenolate mofetil in the last 30 days
* Patient who are on prednisone therapy at a dose \> 10 mg/day in the last 15 days
* Patients who received rituximab previously with CD20 count of \< 5 cells/microliter at the time of enrollment
* For women who are not postmenopausal (greater than or equal to \[\>/=\] 12 months of non-therapy-induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to remain abstinent or use two adequate methods of contraception, including at least one method with a failure rate of less than (\<) 1 percent (%) per year, during the treatment period and for at least 18 months after the last dose of study drug
* For men: agreement to remain abstinent or use two adequate methods for contraception, including at least one method with failure rate of less than 1% per year during the treatment period and for at least 6 months (180 days) after the last dose of drug
18 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Ladan Zand
Principal Investigator
Principal Investigators
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Ladan Zand
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Fernando Fervenza, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic
Rochester, Minnesota, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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23-006712
Identifier Type: -
Identifier Source: org_study_id
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