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Tacrolimus Treatment of Patients With Idiopathic Membranous Nephropathy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00302523
First Posted: March 14, 2006
Last Update Posted: February 3, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Zhi-Hong Liu, M.D., Nanjing University School of Medicine
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Tacrolimus Treatment of Patients With Idiopathic

Resource links provided by NLM:


Further study details as provided by Zhi-Hong Liu, M.D., 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 ]

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

Enrollment: 16
Study Start Date: March 2006
Study Completion Date: December 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: FK506 Drug: Tacrolimus
FK506,0.1mg/kg/d
Other Name: Tacrolimus,Prograf

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

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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 18-60 years 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00302523


Locations
China, Jiangsu
Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine
Nanjing, Jiangsu, China, 210002
Research Institute of Nephrology, Jinling Hospital
Nanjing, Jiangsu, China, 210002
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: Zhi-Hong Liu, M.D., Research Institute of Nephrology, Nanjing University School of Medicine
ClinicalTrials.gov Identifier: NCT00302523     History of Changes
Other Study ID Numbers: NJCT-0603
First Submitted: March 13, 2006
First Posted: March 14, 2006
Last Update Posted: February 3, 2012
Last Verified: February 2012

Keywords provided by Zhi-Hong Liu, M.D., Nanjing University School of Medicine:
Idiopathic Membranous Nephropathy
Treatment
Tacrolimus
Cyclophosphamide

Additional relevant MeSH terms:
Kidney Diseases
Glomerulonephritis, Membranous
Urologic Diseases
Glomerulonephritis
Nephritis
Autoimmune Diseases
Immune System Diseases
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action