Overview
The purpose of this research is to learn if Obinutuzumab is effective and safe in treating patients with fibrillary glomerulonephritis (FGN).
Eligibility
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