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

Shiraz University of Medical Sciences

Status and phase: Completed; Phase 3; Phase 2

Conditions: Diabetic Nephropathy

Treatments: Drug: Captopril + Pentoxifylline; Drug: Captopril

Study type: Interventional

Funder types: Other

Identifiers

NCT00663949

3079

Details and patient eligibility

About

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.

Full 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).

Enrollment: 70 patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

A,1,II

Active Comparator group

Description:

patients in this arm takes 25 mg captopril q8h

Treatment:

Drug: Captopril

A,2,II

Active Comparator group

Treatment:

Drug: Captopril + Pentoxifylline