A Single-Center Phase 2 Open-Label Trial Evaluating the Efficacy and Safety of Obinutuzumab in Treatment of Fibrillary Glomerulonephritis
Mayo Clinic
Summary
The purpose of this research is to learn if Obinutuzumab is effective and safe in treating patients with fibrillary glomerulonephritis (FGN).
Eligibility
- Age range
- 18+ years
- Sex
- All
- 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 ex…
Interventions
- DrugObinutuzumab
Obinutuzumab 1g IV on day one and 1 g IV on day 15, followed by identical course at month 6.
Location
- Mayo ClinicRochester, Minnesota