Mayo Clinic
Rochester, Minnesota, 55905, United States
Location status: Recruiting
Location contact
Corbyn Bendtsen
CONTACT
Ladan Zand
PRINCIPAL_INVESTIGATOR
Nicholas Geroux
CONTACT
NCT Number: NCT06295770
The purpose of this research is to learn if Obinutuzumab is effective and safe in treating patients with fibrillary glomerulonephritis (FGN).
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 2
Rochester, Minnesota, 55905, United States
Location status: Recruiting
Corbyn Bendtsen
CONTACT
Ladan Zand
PRINCIPAL_INVESTIGATOR
Nicholas Geroux
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Obinutuzumab 1g IV on day one and 1 g IV on day 15, followed by identical course at month 6.
Other names: Gazyva
Time frame: Baseline, 6 months, 12 months
Measured using 24-hour urine collection reported in mg/24h
Time frame: Baseline, 6 months
Measured using 24-hour urine collection reported in mg/24h
Time frame: 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
Time frame: Baseline, 6 months, 12 months
Blood serum collected and reported in g/dL
Time frame: 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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Corbyn Bendtsen
CONTACT
Nicholas Geroux
CONTACT
Mayo Clinic
Other
A Single-Center Phase 2 Open-Label Trial Evaluating the Efficacy and Safety of Obinutuzumab in Treatment of Fibrillary Glomerulonephritis
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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