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NCT Number: NCT00663949

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

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Key information

Conditions

Diabetic Nephropathy Diabetes Complications Diabetes Mellitus Diabetic Nephropathies Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Proteinuria Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Shiraz University of Medical Sciences ,Nemazee and Faghihi Hospital

Shiraz, Fars, 0098, Iran

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

captopril

Drug

25 mg captopril tablet q8h

Captopril + Pentoxifylline

Drug

patients takes captopril tablets 25 mg q8h and pentoxifylline 400 mg q8h

Primary outcomes

  1. decreasing urinary protein

    Time frame: 2 and 6 months

Sponsors and collaborators

Lead sponsor

Shiraz University of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2007
Study completion
2008
First posted
Apr 22, 2008
Registry last updated
Apr 22, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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