NCT02197767

Pilot Study of Rituximab to Treat Fibrillary Glomerulonephritis

A Single Center Pilot Trial of Rituximab in the Treatment of Fibrillary Glomerulonephritis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

This pilot study is being done to see if the study medication, Rituximab, preserves kidney function after 12 months of taking the drug.

Detailed description

This is a Phase II, open-label pilot study to determine if the use of Rituximab reduces proteinuria over a 12 month period and is there preservation of kidney function with the use of this study drug. Each patient will be treated with 2 intravenous infusions of rituximab 1000 mg, two weeks apart for a total of 2 doses. Each patient will be retreated with identical 2 intravenous infusions of rituximab, two weeks apart at 6 months after the first infusion, irrespective of cluster of differentiation (CD) 20+ cell counts. Thus, each participant will receive 4 infusions of rituximab.

Conditions

• Fibrillary Glomerulonephritis

Interventions

Type	Name	Description
DRUG	rituximab	1000 mg infusion

Timeline

• Start date: 2014-11-01
• Primary completion: 2017-04-01
• Completion: 2017-04-01
• First posted: 2014-07-23
• Last updated: 2019-02-06
• Results posted: 2019-02-06

Locations

1 site across 1 country: United States