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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00362531
Other study ID # PRGNSCN01-0
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received August 9, 2006
Last updated August 9, 2006
Start date November 2004
Est. completion date January 2007

Study information

Verified date January 2006
Source Peking University
Contact n/a
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date January 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
tacrolimus combined with prednisone


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Peking University

Outcome

Type Measure Description Time frame Safety issue
Primary complete remission of renal disease at 12 months
Secondary partial remission at 12 months and adverse events
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