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

• ClinicalTrials.gov Identifier: NCT00362531
• Recruitment Status: Completed
• First Posted: August 10, 2006
• Last Update Posted: August 10, 2006
• Sponsor: Peking University
• Information provided by: Peking University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Idiopathic Membranous Nephropathy; Nephrotic Syndrome	Drug: tacrolimus combined with prednisone	Phase 2; Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase 3 Study of Tacrolimus Combined With Prednisone Treatment of Idiopathic Membranous Nephropathy and Nephrotic Syndrome
• Study Start Date: November 2004
• Study Completion Date: January 2007

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

1. complete remission of renal disease at 12 months

Secondary Outcome Measures :

1. partial remission at 12 months and adverse events

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Sponsors and Collaborators

Peking University

Investigators

• Principal Investigator: Haiyan WANG, MD; Renal Division, Peking University First Hospital
• Principal Investigator: Jianghua Chen, MD; Department of Nephrology, First Hospital of Zhejiang University
• Principal Investigator: Xuewang Li, MD; Department of Nephrology, Peking Union Medical College Hospital
• Principal Investigator: Fuming Lu, MD; Department of Nephrology, Huashan Hospital, Fudan University
• Principal Investigator: Feifei Xu, MD; Department of Nephrology, First Hospital of Wenzhou Medical College
• Principal Investigator: Jiaqi Qian, MD; Department of Nephrology, Renji Hospital of Shanghai
• Principal Investigator: Fanfan Hou, MD; Department of Nephrology, Nanfang Hospital, First Military Medical University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• ClinicalTrials.gov Identifier: NCT00362531
• Other Study ID Numbers: PRGNSCN01-0
• First Posted: August 10, 2006
• Last Update Posted: August 10, 2006
• Last Verified: January 2006

Additional relevant MeSH terms:

Kidney Diseases; Nephrotic Syndrome; Nephrosis; Glomerulonephritis, Membranous; Syndrome; Disease; Pathologic Processes; Urologic Diseases; Glomerulonephritis; Nephritis; Autoimmune Diseases; Immune System Diseases; Prednisone; Tacrolimus; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Antineoplastic Agents, Hormonal; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Calcineurin Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action