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

Primary Purpose

Diabetic Nephropathy

Status
Completed
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Captopril
Captopril + Pentoxifylline
Sponsored by
Shiraz University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Nephropathy focused on measuring diabetes, proteinuria, pentoxifylline

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shiraz University of Medical Sciences ,Nemazee and Faghihi Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

A,1,II

A,2,II

Arm Description

patients in this arm takes 25 mg captopril q8h

Outcomes

Primary Outcome Measures

decreasing urinary protein

Secondary Outcome Measures

Full Information

First Posted
April 21, 2008
Last Updated
April 21, 2008
Sponsor
Shiraz University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT00663949
Brief Title
Assessment of the Effect of Captopril Versus Combination of Captopril and Pentoxifylline on Reducing Proteinuria in Type 2 Diabetic Nephropathy
Official Title
Phase 2 Trial of Effect of Combine Pentoxifylline and Captopril on Proteinuria in Diabetic Nephropathy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2008
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
January 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Shiraz University of Medical Sciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Nephropathy
Keywords
diabetes, proteinuria, pentoxifylline

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A,1,II
Arm Type
Active Comparator
Arm Description
patients in this arm takes 25 mg captopril q8h
Arm Title
A,2,II
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Captopril
Intervention Description
25 mg captopril tablet q8h
Intervention Type
Drug
Intervention Name(s)
Captopril + Pentoxifylline
Intervention Description
patients takes captopril tablets 25 mg q8h and pentoxifylline 400 mg q8h
Primary Outcome Measure Information:
Title
decreasing urinary protein
Time Frame
2 and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Absence of kidney or urinary tract disease Absence of high blood pressure OR Controlled blood pressure (≤140/90) with medication other than ACE inhibitors and/or non dihydropyridine calcium channel blockers A well controlled blood sugar level (HbA1c≤7.5%) Adhering to the diet protocol for patients with renal disease Exclusion Criteria: NYHA functional class III, IV Valvular heart disease Unstable angina, myocardial infarction, cerebrovascular accidents Psychiatric disease Prior allograft kidney transplant Acute illness Infectious disease including urinary tract infection Leukocytosis or any febrile illness at enrollment Prior history or development of any form of malignancy History of alcohol or drug abuse or smoking Pregnancy Need for surgery during the study Allergy to derivatives of methyl xanthines Current Pentoxyphilline use
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jamshid Roozbeh, MD
Organizational Affiliation
sums
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
mohammad ghezloo, MD
Organizational Affiliation
SUMS
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
mohammad mahdi sagheb, MD
Organizational Affiliation
SUMS
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Amin Banihashemi
Organizational Affiliation
SUMS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shiraz University of Medical Sciences ,Nemazee and Faghihi Hospital
City
Shiraz
State/Province
Fars
ZIP/Postal Code
0098
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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