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

NCT ID: NCT00362531

Last Updated: 2006-08-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2007-01-31

Brief Summary

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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

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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.

Conditions

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Idiopathic Membranous Nephropathy Nephrotic Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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tacrolimus combined with prednisone

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University

OTHER

Sponsor Role lead

Principal Investigators

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Haiyan WANG, MD

Role: PRINCIPAL_INVESTIGATOR

Renal Division, Peking University First Hospital

Jianghua Chen, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Nephrology, First Hospital of Zhejiang University

Xuewang Li, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Nephrology, Peking Union Medical College Hospital

Fuming Lu, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Nephrology, Huashan Hospital, Fudan University

Feifei Xu, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Nephrology, First Hospital of Wenzhou Medical College

Jiaqi Qian, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Nephrology, Renji Hospital of Shanghai

Fanfan Hou, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Nephrology, Nanfang Hospital, First Military Medical University

References

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von Groote TC, Williams G, Au EH, Chen Y, Mathew AT, Hodson EM, Tunnicliffe DJ. Immunosuppressive treatment for primary membranous nephropathy in adults with nephrotic syndrome. Cochrane Database Syst Rev. 2021 Nov 15;11(11):CD004293. doi: 10.1002/14651858.CD004293.pub4.

Reference Type DERIVED
PMID: 34778952 (View on PubMed)

Other Identifiers

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NCT00268567

Identifier Type: -

Identifier Source: secondary_id

PRGNSCN01-0

Identifier Type: -

Identifier Source: org_study_id