Viewing Study NCT00362531



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Last Modification Date: 2024-10-26 @ 9:26 AM
Study NCT ID: NCT00362531
Status: COMPLETED
Last Update Posted: 2006-08-10
First Post: 2006-08-09

Brief Title: Tacrolimus Combined With Prednisone Treatment of Idiopathic Membranous Nephropathy and Nephrotic Syndrome
Sponsor: Peking University
Organization: Peking University

Study Overview

Official Title: Phase 3 Study of Tacrolimus Combined With Prednisone Treatment of Idiopathic Membranous Nephropathy and Nephrotic Syndrome
Status: COMPLETED
Status Verified Date: 2006-01
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: Idiopathic membranous nephropathy IMN is one of the most common forms of nephrotic syndrome NS in adults and is usually treated by corticosteroids in combination with cytotoxic drugs especially cyclophosphamide or cyclosporine Tacrolimus a new immunosuppressive agent was proved to be effective in treating refractory NS Whether it is effective in IMN has not been reported We therefore undertook a multi-center controlled study to investigate the efficacy and safety profile of tacrolimus compared with cyclophosphamide in the treatment of patients with idiopathic membranous nephropathy and nephrotic syndrome
Detailed Description: Idiopathic membranous nephropathy IMN is one of the most common forms of nephrotic syndrome NS in adults and is usually treated by corticosteroids in combination with cytotoxic drugs especially cyclophosphamide or cyclosporine However the effect was not satisfying and the side-effects of the above immunosuppressive agents were often a worrying problem Tacrolimus a new immunosuppressive agent was proved to be effective in treating refractory NS especially FSGS Whether it is effective in IMN has not been reported We therefore undertook a multi-center controlled study to investigate the efficacy and safety profile of tacrolimus compared with cyclophosphamide in the treatment of patients with idiopathic membranous nephropathy and nephrotic syndrome

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
Secondary IDs
Secondary ID Type Domain Link
NCT00268567 None None None