The purpose of this research is to learn if Obinutuzumab is effective and safe in treating patients with fibrillary glomerulonephritis (FGN).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Obinutuzumab 1g IV on day one and 1 g IV on day 15, followed by identical course at month 6.
Mayo Clinic
Rochester, Minnesota, United States
RECRUITINGChange in proteinuria from baseline to 12 months post treatment with Obinutuzumab
Measured using 24-hour urine collection reported in mg/24h
Time frame: Baseline, 6 months, 12 months
Change in proteinuria from baseline to 6 months post treatment with Obinutuzumab
Measured using 24-hour urine collection reported in mg/24h
Time frame: Baseline, 6 months
Rate of complete or partial remission
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
Time frame: 6 months, 12 months
Improvement in serum albumin
Blood serum collected and reported in g/dL
Time frame: 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.
Time frame: 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.
Time frame: Day 1-12 months
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