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

This study has been completed.
Sponsor:
Information provided by:
Peking University
ClinicalTrials.gov Identifier:
NCT00362531
First received: August 9, 2006
Last updated: NA
Last verified: January 2006
History: No changes posted
  Purpose

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 Intervention Phase
Idiopathic Membranous Nephropathy
Nephrotic Syndrome
Drug: tacrolimus combined with prednisone
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 3 Study of Tacrolimus Combined With Prednisone Treatment of Idiopathic Membranous Nephropathy and Nephrotic Syndrome

Resource links provided by NLM:


Further study details as provided by Peking University:

Primary Outcome Measures:
  • complete remission of renal disease at 12 months

Secondary Outcome Measures:
  • partial remission at 12 months and adverse events

Study Start Date: November 2004
Estimated Study Completion Date: January 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00362531

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

No publications provided

ClinicalTrials.gov Identifier: NCT00362531     History of Changes
Other Study ID Numbers: PRGNSCN01-0
Study First Received: August 9, 2006
Last Updated: August 9, 2006
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Glomerulonephritis, Membranous
Kidney Diseases
Nephrotic Syndrome
Glomerulonephritis
Nephritis
Urologic Diseases
Autoimmune Diseases
Immune System Diseases
Nephrosis
Prednisone
Tacrolimus
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on August 26, 2014