Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this research is to learn if Obinutuzumab is effective and safe in treating patients with fibrillary glomerulonephritis (FGN).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Obinutuzumab in Treatment of Fibrillary Glomerulonephritis | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Obinutuzumab | Drug | Obinutuzumab 1g IV on day one and 1 g IV on day 15, followed by identical course at month 6. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in proteinuria from baseline to 12 months post treatment with Obinutuzumab | Measured using 24-hour urine collection reported in mg/24h | Baseline, 6 months, 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in proteinuria from baseline to 6 months post treatment with Obinutuzumab | Measured using 24-hour urine collection reported in mg/24h | Baseline, 6 months |
| Rate of complete or partial remission |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nicholas Geroux | Contact | 507-266-0956 | Geroux.nicholas@mayo.edu | |
| Corbyn Bendtsen | Contact | 507-284-0366 | Bendtsen.corbyn@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Ladan Zand | Mayo Clinic | Principal Investigator |
| Fernando Fervenza, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Recruiting | Rochester | Minnesota | 55905 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C543332 | obinutuzumab |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
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
| 6 months, 12 months |
| Improvement in serum albumin | Blood serum collected and reported in g/dL | Baseline, 6 months, 12 months |
| Stabilization of kidney function | 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. | Baseline, 6 months, 12 months |
| Serious Adverse Events (SAEs) | Rate of all Serious Adverse Events (SAEs) including serious infection defined as severe UTI or pyelonephritis, pneumonias or other systemic infections requiring hospitalization. | Day 1-12 months |