Ignite Creation Date:
2024-05-05 @ 5:36 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00498368
Status:
COMPLETED
Last Update Posted:
2017-02-01
First Post:
2007-07-09
Brief Title:
Rituximab in Progressive Immunoglobulin A IgA Nephropathy
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
A Multicenter Randomized Prospective Open-Label Trial of Rituximab in the Treatment of Progressive IgA Nephropathy
Status:
COMPLETED
Status Verified Date:
2016-12
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 study was about IgA nephropathy a form of kidney disease characterized by the presence of blood and protein in the urine This study was done to determine if the medication rituximab could reduce protein in the patients urine
Hypothesis In patients with progressive IgA nephropathy an intravenous infusion of 1000 mg of rituximab on Day 1 and Day 15 and Days 168 and 182 is superior to conventional therapy in reducing 24 hour proteinuria and slowing progression of chronic kidney disease
Hypothesis In patients with progressive IgA nephropathy an intravenous infusion of 1000 mg of rituximab on Day 1 and Day 15 and Days 168 and 182 is superior to conventional therapy in reducing 24 hour proteinuria and slowing progression of chronic kidney disease
Detailed Description:
Recent clinical success in the use of Rituximab in the treatment of Lupus nephritis and other forms immune complex glomerulonephritis has led to its investigation in the treatment of IgA nephropathy Because IgA class antibodies have comparatively short half-lives and that deposition of polymeric forms of IgA contributes to glomerular injury the researchers speculated that the reduction of circulating IgA could reduce proteinuria and injury in patients with IgA nephropathy
Treatment and Follow-up
Subjects were randomly assigned to receive rituximab or to continue standard care Both arms received a Omega-3 Fatty Acid Fish Oil Supplement and angiotensin converting enzyme ACE inhibitors andor Angiotensin II receptor blockers ARBs ACE inhibitors andor ARBs were used to achieve a blood pressure goal of 13080 mmHg
The study was an open-label trial those assigned to rituximab received a 1 g infusion of rituximab followed by an identical dose 2 weeks later Premedication with corticosteroids 10 mg dexamethasone intravenously was also given 30 min prior to the first infusion of each series of rituximab They received an identical 2 g course of rituximab 6 months later Subjects were assessed at least every 3 months or as needed for clinical events This assessment included physical examination a questionnaire for adverse events and measurement of routine hematology serum chemistry timed urine protein excretion and for those assigned to rituximab B-cell subsets Follow-up was considered complete at 12 months
Treatment and Follow-up
Subjects were randomly assigned to receive rituximab or to continue standard care Both arms received a Omega-3 Fatty Acid Fish Oil Supplement and angiotensin converting enzyme ACE inhibitors andor Angiotensin II receptor blockers ARBs ACE inhibitors andor ARBs were used to achieve a blood pressure goal of 13080 mmHg
The study was an open-label trial those assigned to rituximab received a 1 g infusion of rituximab followed by an identical dose 2 weeks later Premedication with corticosteroids 10 mg dexamethasone intravenously was also given 30 min prior to the first infusion of each series of rituximab They received an identical 2 g course of rituximab 6 months later Subjects were assessed at least every 3 months or as needed for clinical events This assessment included physical examination a questionnaire for adverse events and measurement of routine hematology serum chemistry timed urine protein excretion and for those assigned to rituximab B-cell subsets Follow-up was considered complete at 12 months
Study Oversight
Has Oversight DMC:
None
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?:
None