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Assessment of the Effect of Captopril Versus Combination of Captopril and Pentoxifylline on Reducing Proteinuria in Type 2 Diabetic Nephropathy
This study has been completed.
Study NCT00663949   Information provided by Shiraz University of Medical Sciences
First Received: April 21, 2008   No Changes Posted

April 21, 2008
April 21, 2008
February 2006
December 2007   (final data collection date for primary outcome measure)
decreasing urinary protein [ Time Frame: 2 and 6 months ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
 
 
 
Assessment of the Effect of Captopril Versus Combination of Captopril and Pentoxifylline on Reducing Proteinuria in Type 2 Diabetic Nephropathy
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.

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).

Phase II, Phase III
Interventional
Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Diabetic Nephropathy
  • Drug: Captopril
  • Drug: Captopril + Pentoxifylline
Active Comparator: patients in this arm takes 25 mg captopril q8h
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
70
January 2008
December 2007   (final data collection date for primary outcome measure)

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
Both
30 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Iran, Islamic Republic of
 
NCT00663949
shiraz university of medical sciences vice chancellor for research, SUMS
3079
Shiraz University of Medical Sciences
 
Study Chair: Jamshid Roozbeh, MD sums
Study Director: mohammad ghezloo, MD SUMS
Principal Investigator: mohammad mahdi sagheb, MD SUMS
Principal Investigator: Amin Banihashemi SUMS
Shiraz University of Medical Sciences
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP