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

NCT ID: NCT00663949

Last Updated: 2008-04-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2008-01-31

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).

Conditions

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Diabetic Nephropathy

Keywords

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diabetes proteinuria pentoxifylline

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A,1,II

patients in this arm takes 25 mg captopril q8h

Group Type ACTIVE_COMPARATOR

Captopril

Intervention Type DRUG

25 mg captopril tablet q8h

A,2,II

Group Type ACTIVE_COMPARATOR

Captopril + Pentoxifylline

Intervention Type DRUG

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

Interventions

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Captopril

25 mg captopril tablet q8h

Intervention Type DRUG

Captopril + Pentoxifylline

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shiraz University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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SUMS

Principal Investigators

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Jamshid Roozbeh, MD

Role: STUDY_CHAIR

sums

mohammad ghezloo, MD

Role: STUDY_DIRECTOR

SUMS

mohammad mahdi sagheb, MD

Role: PRINCIPAL_INVESTIGATOR

SUMS

Amin Banihashemi

Role: PRINCIPAL_INVESTIGATOR

SUMS

Locations

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Shiraz University of Medical Sciences ,Nemazee and Faghihi Hospital

Shiraz, Fars, Iran

Site Status

Countries

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Iran

Other Identifiers

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3079

Identifier Type: -

Identifier Source: org_study_id