Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00135954
Status:
COMPLETED
Last Update Posted:
2014-01-28
First Post:
2005-08-25
Brief Title:
Treatment of Patients With Idiopathic Membranous Nephropathy
Sponsor:
Radboud University Medical Center
Organization:
Radboud University Medical Center
Study Overview
Official Title:
Treatment of Patients With Idiopathic Membranous Nephropathy at Risk for Renal Insufficiency Comparison of Early Versus Late Start of Immunosuppressive Therapy
Status:
COMPLETED
Status Verified Date:
2007-02
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:
Patients with idiopathic membranous nephropathy at risk for renal failure can be identified in an early stage by measuring urinary low molecular weight proteins and urinary immunoglobulin G IgG This study evaluates the possible benefit of early start of immunosuppressive therapy in these high-risk patients
Detailed Description:
Inclusion Criteria
patients with idiopathic membranous nephropathy
nephrotic syndrome
normal renal function serum creatinine Screat 15 mgdl
elevated urinary beta2-microglobulin and IgG
Immunosuppressive therapy consisting of
cyclophosphamide 15 mgkgday for 12 months
prednisone orally 05 mgkg on alternate days for 6 months
iv methylprednisolone 1000 mg on days 123 606162 120121122
Study Groups
early immediate start of immunosuppressive therapy at the time patient is identified as high-risk
late start of therapy after deterioration of renal function increase of Screat 25 and Screat 15 mgdl
Main Outcome Parameters
serum creatinine
remission of proteinuria
period of nephrotic proteinuria
major side effects hospitalisations infections
patients with idiopathic membranous nephropathy
nephrotic syndrome
normal renal function serum creatinine Screat 15 mgdl
elevated urinary beta2-microglobulin and IgG
Immunosuppressive therapy consisting of
cyclophosphamide 15 mgkgday for 12 months
prednisone orally 05 mgkg on alternate days for 6 months
iv methylprednisolone 1000 mg on days 123 606162 120121122
Study Groups
early immediate start of immunosuppressive therapy at the time patient is identified as high-risk
late start of therapy after deterioration of renal function increase of Screat 25 and Screat 15 mgdl
Main Outcome Parameters
serum creatinine
remission of proteinuria
period of nephrotic proteinuria
major side effects hospitalisations infections
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