Overview

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

Status:
Completed

Trial end date:
2007-01-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 2/Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Peking University

Treatments:

Prednisone
Tacrolimus

Criteria

Inclusion Criteria:

- All patients were diagnosed as idiopathic membranous nephropathy according to renal
histology, with nephrotic syndrome, serum creatinine less than 2.5mg/dL, 18~70 years
old, signed the informed consent and willing to be followed up according to the
protocol.

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, severe
infection, diabetes mellitus, liver disease, pregnancy, lactating, and anticipated
poor compliance with the protocol.