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Tacrolimus Treatment of Patients With Idiopathic Membranous Nephropathy
This study is currently recruiting participants.
Verified by Nanjing University School of Medicine, July 2008
Sponsored by: Nanjing University School of Medicine
Information provided by: Nanjing University School of Medicine
ClinicalTrials.gov Identifier: NCT00302523
  Purpose

The purpose of this study is:

  • To explore the potential role of tacrolimus in the treatment of membranous nephropathy.
  • To investigate the safety and tolerability of tacrolimus vs methylprednisolone plus cyclophosphamide.

Condition Intervention
Idiopathic Membranous Nephropathy
Drug: Tacrolimus

Drug Information available for: Cyclophosphamide Tacrolimus Tacrolimus anhydrous
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Tacrolimus Treatment of Patients With Idiopathic

Further study details as provided by Nanjing University School of Medicine:

Primary Outcome Measures:
  • To explore the potential role of tacrolimus in the treatment of membranous nephropathy. [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To investigate the safety and tolerability of tacrolimus vs intravenous CTX pulse. [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: March 2006
Estimated Study Completion Date: December 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Experimental Drug: Tacrolimus
FK506,0.1mg/kg/d

Detailed Description:

Idiopathic membranous nephropathy is the most common cause of nephrotic syndrome in adults. Over the past decade, a number of studies have reported therapeutic efficacy for treatment with Cyclosporine-A (CSA) in patients with nephrotic syndrome including patients with membranous nephropathy. This study will evaluate the safety and effectiveness of a new calcineurin immunosuppressive drug, tacrolimus (FK506), in reducing the amount of protein in the urine in patients with membranous nephropathy. Forty patients with biopsy-proven membranous nephropathy will be recruited. Candidates must have completed at least six month of treatment with a stable dose of angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs). They will be screened with a medical history, physical examination, blood tests, and an examination for infection, cancers, and other conditions that can cause membranous nephropathy. The investigators plan to conduct an open-label study of the efficacy and safety of tacrolimus in the treatment of membranous nephropathy. They will be treated with oral tacrolimus for 6 months, followed by 6 months of maintenance. Proteinuria, renal function will be monitored. Complete remission is defined as 24-hour urinary protein excretion to less than 0.4 mg/day. This study will explore the potential role of tacrolimus in the treatment of membranous nephropathy, which is usually resistant to conventional therapy.

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Biopsy-proven idiopathic membranous nephropathy
  • Nephrotic syndrome with proteinuria ( > 4 g/day) and serum albumin < 30 g/dl
  • Age over 18 with informed consent

Exclusion Criteria:

  • Patient with abnormal liver function tests
  • Prior therapy with sirolimus, CSA, MMF, or azathioprin, cytoxan, chlorambucil, levamisole, methotrexate, or nitrogen mustard in the last 90 days
  • Active/serious infection
  • Patient with hepatitis B surface antigen or who is hepatitis C antibody positive
  • Patient who is diabetic
  • Patient is allergic or intolerant to macrolide antibiotics or tacrolimus
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00302523

Contacts
Contact: Shijun Li, M.D. 86-25-80860469 lsj8855@yahoo.com.cn

Locations
China, Jiangsu
Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine Recruiting
Nanjing, Jiangsu, China, 210002
Contact: Shijun Li, M.D.     86-25-80860469     lsj8855@yahoo.com.cn    
Principal Investigator: Zhi-hong Liu, M.D.            
Sponsors and Collaborators
Nanjing University School of Medicine
Investigators
Study Director: Zhi-hong Liu, M.D. Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine
  More Information

Responsible Party: Nanjing University School of Medicine ( Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine )
Study ID Numbers: NJCT-0603
Study First Received: March 13, 2006
Last Updated: July 25, 2008
ClinicalTrials.gov Identifier: NCT00302523  
Health Authority: China: State Food and Drug Administration

Keywords provided by Nanjing University School of Medicine:
Idiopathic Membranous Nephropathy
Treatment
Tacrolimus
Cyclophosphamide

Study placed in the following topic categories:
Glomerulonephritis
Autoimmune Diseases
Urologic Diseases
Nephritis
Glomerulonephritis, Membranous
Tacrolimus
Cyclophosphamide
Kidney Diseases
Membranous nephropathy, idiopathic

Additional relevant MeSH terms:
Immunologic Factors
Immune System Diseases
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009