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

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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00663949

Enrollment

Registered

2008-04-22

Start date

2006-02-28

Completion date

2008-01-31

Last updated

2008-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Nephropathy

Keywords

diabetes, proteinuria, pentoxifylline

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).

Interventions

DRUGCaptopril

25 mg captopril tablet q8h

DRUGCaptopril + Pentoxifylline

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

30 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame
decreasing urinary protein	2 and 6 months

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026