Tacrolimus Combined With Prednisone Treatment of Idiopathic Membranous Nephropathy and Nephrotic Syndrome

Last updated: August 9, 2006
Sponsor: Peking University
Overall Status: Completed

Phase

2/3

Condition

Nephrotic Syndrome

Idiopathic Membranous Nephropathy

Focal Segmental Glomerulosclerosis

Treatment

N/A

Clinical Study ID

NCT00362531
PRGNSCN01-0
  • Ages 18-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • All patients were diagnosed as idiopathic membranous nephropathy according to renalhistology, with nephrotic syndrome, serum creatinine less than 2.5mg/dL, 18~70 yearsold, signed the informed consent and willing to be followed up according to theprotocol.

Exclusion

Exclusion Criteria:

  • Patients who had received immunosuppressive therapy within the previous 3 months,complicated other severe renal diseases, serum creatinine higher than 2.5mg/dL, severeinfection, diabetes mellitus, liver disease, pregnancy, lactating, and anticipatedpoor compliance with the protocol.

Study Design

Study Start date:
November 01, 2004
Estimated Completion Date:
January 31, 2007

Study 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.