Evaluation of Clinical Efficacy of Pentoxifylline on Patients With Glomerulonephritis

September 8, 2005 updated by: National Taiwan University Hospital
we hypothesize that PTX might be effective in lowering proteinuria by modulating renal MCP-1 production in human glomerulonephritis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Pentoxifylline (PTX) is a phosphodiesterase inhibitor that is widely used for the treatment of peripheral vascular occlusive disorders. In addition, PTX has shown its ability to attenuate nephrotic syndrome secondary to membranous glomerulonephritis and lupus nephritis, and to reduce subnephrotic proteinuria due to early and advanced diabetic nephropathy. However, data with respect to its effect on non-nephrotic primary glomerular diseases are lacking. Moreover, while the anti-proteinuric effect of PTX has been largely attributed to down-regulation of TNF-a, it remains unknown whether other mediators, especially MCP-1, are also affected by PTX. Because our previous works have shown that PTX attenuates proteinuria and suppresses renal MCP-1 mRNA expression in experimental glomerulonephritis in rats, we hypothesize that PTX might be effective in lowering proteinuria by modulating renal MCP-1 production in human glomerulonephritis. This study was thereby conducted to investigate the potential anti-proteinuric and anti-MCP-1 effects of PTX in subnephrotic patients with primary glomerular diseases.

Study Type

Interventional

Enrollment

20

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

  • Taiwan
      • Taipei, Taiwan, 100
        • Yung-Ming Chen

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

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • glomerular diseases with subnephrotic proteinuria

Exclusion Criteria:

  • DM, hepatitis, systemic immunologic renal diseases

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
proteinuria

Secondary Outcome Measures

Outcome Measure
inflammatory mediators

Collaborators and Investigators

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

Sponsor

National Taiwan University Hospital

Investigators

  • Study Chair: Pan-Chyr Yang, Professor and vice-Dean

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

January 1, 2000

Study Completion

June 1, 2001

Study Registration Dates

First Submitted

September 8, 2005

First Submitted That Met QC Criteria

September 8, 2005

First Posted (Estimate)

September 12, 2005

Study Record Updates

Last Update Posted (Estimate)

September 12, 2005

Last Update Submitted That Met QC Criteria

September 8, 2005

Last Verified

June 1, 2001

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 152S2

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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