Tacrolimus Treatment of Patients With Idiopathic Membranous Nephropathy

February 2, 2012 updated by: Zhi-Hong Liu, M.D., Nanjing University School of Medicine

Tacrolimus Treatment of Patients With Idiopathic

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210002
        • Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine
      • Nanjing, Jiangsu, China, 210002
        • Research Institute of Nephrology, Jinling Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: FK506
Drug: Tacrolimus
FK506,0.1mg/kg/d
Other Names:
  • Tacrolimus,Prograf

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To explore the potential role of tacrolimus in the treatment of membranous nephropathy.
Time Frame: 18 months
18 months

Secondary Outcome Measures

Outcome Measure
Time Frame
To investigate the safety and tolerability of tacrolimus vs intravenous CTX pulse.
Time Frame: 18 months
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing University School of Medicine

Investigators

  • Study Director: Zhi-hong Liu, M.D., Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (ACTUAL)

December 1, 2008

Study Completion (ACTUAL)

December 1, 2009

Study Registration Dates

First Submitted

March 13, 2006

First Submitted That Met QC Criteria

March 13, 2006

First Posted (ESTIMATE)

March 14, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

February 3, 2012

Last Update Submitted That Met QC Criteria

February 2, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NJCT-0603

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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