Official Title: “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 Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: December 2007

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).

Intervention(s) in this Clinical Trial

• Drug: Captopril
  • 25 mg captopril tablet q8h
• Drug: Captopril + Pentoxifylline
  • patients takes captopril tablets 25 mg q8h and pentoxifylline 400 mg q8h

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: A,1,II
  • patients in this arm takes 25 mg captopril q8h
• Active Comparator: A,2,II

Primary Measures

• decreasing urinary protein
  • Time Frame: 2 and 6 months
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 30 Years

Maximum Age for this Clinical Trial: 70 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Shiraz University of Medical Sciences

Overall Clinical Trial Officials and Contacts

Jamshid Roozbeh, MD Study Chair sums  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00663949

Study ID Number: 3079

ClinicalTrials.gov Identifier: NCT00663949

Health Authority: Iran: Ethics Committee