Assessment of the Effect of Captopril Versus Combination of Captopril and Pentoxifylline on Reducing Proteinuria in Type 2 Diabetic Nephropathy

April 21, 2008 updated by: Shiraz University of Medical Sciences

Phase 2 Trial of Effect of Combine Pentoxifylline and Captopril on Proteinuria in Diabetic Nephropathy

Diabetic nephropathy is the most common cause of ESRD and has a great impact on mortality and morbidity of diabetic patients. Despite renoprotective effect of ACE inhibitors in diabetic patients they can not hinder the progression of renal disease completely. Pentoxifylline as a TNFa blocker may hinder progression of diabetic nephropathy in combination of captopril.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Diabetic nephropathy is the most common cause of ESRD and has a great impact on mortality and morbidity of diabetic patients. Despite renoprotective effect of ACE inhibitors in diabetic patients they can not hinder the progression of renal disease completely. TNFa is a cytokine that is a target for medical therapy in diabetic nephropathy. In this study the effect of captopril on overt diabetic nephropathy compared to effect of combination of captopril and an antiTNFa drug ( pentoxifylline).

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 2
  • Phase 3

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

  • Iran, Islamic Republic of
    • Fars
      • Shiraz, Fars, Iran, Islamic Republic of, 0098
        • Shiraz University of Medical Sciences ,Nemazee and Faghihi 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

30 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Absence of kidney or urinary tract disease
  2. Absence of high blood pressure OR Controlled blood pressure (≤140/90) with medication other than ACE inhibitors and/or non dihydropyridine calcium channel blockers
  3. A well controlled blood sugar level (HbA1c≤7.5%)
  4. Adhering to the diet protocol for patients with renal disease

Exclusion Criteria:

  1. NYHA functional class III, IV
  2. Valvular heart disease
  3. Unstable angina, myocardial infarction, cerebrovascular accidents
  4. Psychiatric disease
  5. Prior allograft kidney transplant
  6. Acute illness
  7. Infectious disease including urinary tract infection
  8. Leukocytosis or any febrile illness at enrollment
  9. Prior history or development of any form of malignancy
  10. History of alcohol or drug abuse or smoking
  11. Pregnancy
  12. Need for surgery during the study
  13. Allergy to derivatives of methyl xanthines
  14. Current Pentoxyphilline use

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A,1,II
patients in this arm takes 25 mg captopril q8h
Drug: Captopril
25 mg captopril tablet q8h
Active Comparator: A,2,II
Drug: Captopril + Pentoxifylline
patients takes captopril tablets 25 mg q8h and pentoxifylline 400 mg q8h

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
decreasing urinary protein
Time Frame: 2 and 6 months
2 and 6 months

Collaborators and Investigators

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

Sponsor

Shiraz University of Medical Sciences

Investigators

  • Study Chair: Jamshid Roozbeh, MD, SUMS
  • Study Director: mohammad ghezloo, MD, SUMS
  • Principal Investigator: mohammad mahdi sagheb, MD, SUMS
  • Principal Investigator: Amin Banihashemi, SUMS

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

February 1, 2006

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

January 1, 2008

Study Registration Dates

First Submitted

April 21, 2008

First Submitted That Met QC Criteria

April 21, 2008

First Posted (Estimate)

April 22, 2008

Study Record Updates

Last Update Posted (Estimate)

April 22, 2008

Last Update Submitted That Met QC Criteria

April 21, 2008

Last Verified

March 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3079

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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