Back to resultsTacrolimus Combined With Prednisone Treatment of Idiopathic Membranous Nephropathy and Nephrotic Syndrome
Primary Purpose
Idiopathic Membranous Nephropathy, Nephrotic Syndrome
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
tacrolimus combined with prednisone
Sponsored by
About this trial
This is an interventional treatment trial for Idiopathic Membranous Nephropathy
Eligibility 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.
Sites / Locations
Outcomes
Primary Outcome Measures
complete remission of renal disease at 12 months
Secondary Outcome Measures
partial remission at 12 months and adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00362531
Brief Title
Tacrolimus Combined With Prednisone Treatment of Idiopathic Membranous Nephropathy and Nephrotic Syndrome
Official Title
Phase 3 Study of Tacrolimus Combined With Prednisone Treatment of Idiopathic Membranous Nephropathy and Nephrotic Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
January 2006
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2007 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Peking University
4. Oversight
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Membranous Nephropathy, Nephrotic Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
tacrolimus combined with prednisone
Primary Outcome Measure Information:
Title
complete remission of renal disease at 12 months
Secondary Outcome Measure Information:
Title
partial remission at 12 months and adverse events
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haiyan WANG, MD
Organizational Affiliation
Renal Division, Peking University First Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jianghua Chen, MD
Organizational Affiliation
Department of Nephrology, First Hospital of Zhejiang University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xuewang Li, MD
Organizational Affiliation
Department of Nephrology, Peking Union Medical College Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fuming Lu, MD
Organizational Affiliation
Department of Nephrology, Huashan Hospital, Fudan University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Feifei Xu, MD
Organizational Affiliation
Department of Nephrology, First Hospital of Wenzhou Medical College
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jiaqi Qian, MD
Organizational Affiliation
Department of Nephrology, Renji Hospital of Shanghai
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fanfan Hou, MD
Organizational Affiliation
Department of Nephrology, Nanfang Hospital, First Military Medical University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
34778952
Citation
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.
Results Reference
derived
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Tacrolimus Combined With Prednisone Treatment of Idiopathic Membranous Nephropathy and Nephrotic Syndrome
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