Obinutuzumab in Treatment of Fibrillary Glomerulonephritis
- Registration Number
- NCT06295770
- Lead Sponsor
- Mayo Clinic
- Brief Summary
The purpose of this research is to learn if Obinutuzumab is effective and safe in treating patients with fibrillary glomerulonephritis (FGN).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
- ≥18 years of age
- Biopsy proven fibrillary glomerulonephritis
- Proteinuria > 1.0 g/24hrs prior to initiation of immunosuppressive therapy
- eGFR ≥ 20 ml/min/BSA
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Obinutuzumab in Treatment of Fibrillary Glomerulonephritis Obinutuzumab 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.
- Primary Outcome Measures
Name Time Method Change in proteinuria from baseline to 12 months post treatment with Obinutuzumab Baseline, 6 months, 12 months Measured using 24-hour urine collection reported in mg/24h
- Secondary Outcome Measures
Name Time Method Change in proteinuria from baseline to 6 months post treatment with Obinutuzumab Baseline, 6 months Measured using 24-hour urine collection reported in mg/24h
Rate of complete or partial remission 6 months, 12 months Complete remission: Proteinuria \< 0.5g/24 hrs. and no more than 20% decline in eGFR Partial remission: 50% reduction in proteinuria and proteinuria \< 3.5 g/24hrs and no more than 20% decline in eGFR
Improvement in serum albumin Baseline, 6 months, 12 months Blood serum collected and reported in g/dL
Stabilization of kidney function Baseline, 6 months, 12 months Stabilization is defined as no more than 20% decline in eGFR at 6 months and 12 months. Blood serum collected and reported in mL/min/BSA.
Serious Adverse Events (SAEs) Day 1-12 months Rate of all Serious Adverse Events (SAEs) including serious infection defined as severe UTI or pyelonephritis, pneumonias or other systemic infections requiring hospitalization.
Trial Locations
- Locations (1)
Mayo Clinic
🇺🇸Rochester, Minnesota, United States