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

Information source: Shiraz University of Medical Sciences
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetic Nephropathy

Intervention: Captopril (Drug); Captopril + Pentoxifylline (Drug)

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: Shiraz University of Medical Sciences

Official(s) and/or principal investigator(s):
Jamshid Roozbeh, MD, Study Chair, Affiliation: sums
mohammad ghezloo, MD, Study Director, Affiliation: SUMS
mohammad mahdi sagheb, MD, Principal Investigator, Affiliation: SUMS
Amin Banihashemi, Principal Investigator, Affiliation: SUMS

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: decreasing urinary protein

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).

Eligibility

Minimum age: 30 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Shiraz University of Medical Sciences ,Nemazee and Faghihi Hospital, Shiraz, Fars 0098, Iran, Islamic Republic of
Additional Information

Starting date: February 2006
Last updated: April 21, 2008

Page last updated: August 23, 2015

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