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

Sponsor

Shiraz University of Medical Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT00663949

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Nephropathy	Drug: Captopril Drug: Captopril + Pentoxifylline	Phase 2/Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Feb 1, 2006

Actual Primary Completion Date :

Dec 1, 2007

Actual Study Completion Date :

Jan 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: A,1,II patients in this arm takes 25 mg captopril q8h	Drug: Captopril 25 mg captopril tablet q8h
Active Comparator: A,2,II	Drug: Captopril + Pentoxifylline patients takes captopril tablets 25 mg q8h and pentoxifylline 400 mg q8h

Arm

Intervention/Treatment

Active Comparator: A,1,II

patients in this arm takes 25 mg captopril q8h

Drug: Captopril

25 mg captopril tablet q8h

Active Comparator: A,2,II

Drug: Captopril + Pentoxifylline

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

Outcome Measures

Primary Outcome Measures

decreasing urinary protein [2 and 6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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