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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Diabetic Nephropathy

Intervention / Treatment
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* Drug: Captopril
* Drug: Captopril + Pentoxifylline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A,1,II<br>patients in this arm takes 25 mg captopril q8h | Drug: Captopril<br>* 25 mg captopril tablet q8h<br>|
| Active Comparator: A,2,II<br> | Drug: Captopril + Pentoxifylline<br>* patients takes captopril tablets 25 mg q8h and pentoxifylline 400 mg q8h<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| decreasing urinary protein |  | 2 and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes, proteinuria, pentoxifylline