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

Shiraz University of Medical Sciences70 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetic Nephropathy

Interventions

CaptoprilDRUG

25 mg captopril tablet q8h

Captopril + PentoxifyllineDRUG

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

Eligibility

Sex: ALLMin age: 30 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Shiraz University of Medical Sciences ,Nemazee and Faghihi Hospital

Shiraz, Fars, Iran

Outcomes

Primary Outcomes

decreasing urinary protein

Time frame: 2 and 6 months

Data from ClinicalTrials.gov

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