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

Phase 2

Completed

• Conditions: Diabetic Nephropathy
• Interventions: Drug: Captopril + Pentoxifylline; Drug: Captopril

• Registration Number: NCT00663949
• Lead Sponsor: Shiraz University of Medical Sciences

Brief Summary

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

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 Timeline

• Study Start: 2006-02
• Primary Completion: 2007-12
• Study Completion: 2008-01
• Status Verified: 2008-03
• Study First Submitted: 2008-04-21
• Study First Submitted QC: 2008-04-21
• Last Update Submitted: 2008-04-21
• Study First Posted: 2008-04-22
• Last Update Posted: 2008-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A,2,II	Captopril + Pentoxifylline	-
A,1,II	Captopril	patients in this arm takes 25 mg captopril q8h

Primary Outcome Measures

Name	Time	Method
decreasing urinary protein	2 and 6 months

Trial Locations

Locations (1)

Shiraz University of Medical Sciences ,Nemazee and Faghihi Hospital; 🇮🇷 Shiraz, Fars, Iran, Islamic Republic of