Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-26 @ 1:50 PM
Study NCT ID:
NCT02197767
Status:
COMPLETED
Last Update Posted:
2019-02-06
First Post:
2014-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pilot Study of Rituximab to Treat Fibrillary Glomerulonephritis
Sponsor:
Mayo Clinic
Organization:
Study Overview
Official Title:
A Single Center Pilot Trial of Rituximab in the Treatment of Fibrillary Glomerulonephritis
Status:
COMPLETED
Status Verified Date:
2019-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: