The purpose of this study is to evaluate the safety and efficacy of Obinutuzumab in inducing complete or partial remission of proteinuria.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
1g IV on day one and 1 g IV on day 15, followed by identical course at month 6
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Change in proteinuria
Measured using 24 hour urine collection reported in mg/24h
Time frame: Baseline, 6 months, 12 months
Remission status at 6 months
The number of subjects to reach either complete remission or partial remission at 12 months after infusion. Complete remission defined as proteinuria \< 0.3g/24 hrs. and no more than 20% decline in eGFR. Partial remission defined as 50% reduction in proteinuria and proteinuria \< 3.5 g/24hrs and no more than 20% decline in eGFR.
Time frame: 6 months
Remission status at 12 months
The number of subjects to reach either complete remission or partial remission at 12 months after infusion. Complete remission defined as proteinuria \< 0.3g/24 hrs. and no more than 20% decline in eGFR. Partial remission defined as 50% reduction in proteinuria and proteinuria \< 3.5 g/24hrs and no more than 20% decline in eGFR.
Time frame: 12 months
Change in serum albumin
Blood serum collected and reported in g/dL
Time frame: Baseline, 6 months, 12 months
Serious Adverse Events (SAEs)
Number of subjects to experience serious adverse events including serious infection defined as severe UTI or pyelonephritis, pneumonias or other systemic infections requiring hospitalization
Time frame: 24 months
Proteinuria at 18 months
Measured using 24 hour urine collection reported in mg/24h
Time frame: 18 months
Proteinuria at 24 months
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Measured using 24 hour urine collection reported in mg/24h
Time frame: 24 months