Obinutuzumab in Treatment of Fibrillary Glomerulonephritis
Purpose
The purpose of this research is to learn if Obinutuzumab is effective and safe in treating patients with fibrillary glomerulonephritis (FGN).
Condition
- Fibrillary Glomerulonephritis
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- ≥18 years of age - Biopsy proven fibrillary glomerulonephritis - Proteinuria > 1.0 g/24hrs prior to initiation of immunosuppressive therapy - eGFR ≥ 20 ml/min/BSA
Exclusion Criteria
- Secondary FGN (due to monoclonal gammopathy, autoimmune disease or malignancy) - 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
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental 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. |
|
Recruiting Locations
Mayo Clinic
Rochester 5043473, Minnesota 5037779 55905
Rochester 5043473, Minnesota 5037779 55905
More Details
- NCT ID
- NCT06295770
- Status
- Recruiting
- Sponsor
- Mayo Clinic