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Sponsored by: |
Shiraz University of Medical Sciences |
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Information provided by: | Shiraz University of Medical Sciences |
ClinicalTrials.gov Identifier: | NCT00663949 |
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 | Intervention | Phase |
---|---|---|
Diabetic Nephropathy |
Drug: Captopril Drug: Captopril + Pentoxifylline |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Phase 2 Trial of Effect of Combine Pentoxifylline and Captopril on Proteinuria in Diabetic Nephropathy |
Enrollment: | 70 |
Study Start Date: | February 2006 |
Study Completion Date: | January 2008 |
Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A,1,II: Active Comparator
patients in this arm takes 25 mg captopril q8h
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Drug: Captopril
25 mg captopril tablet q8h
|
A,2,II: Active Comparator |
Drug: Captopril + Pentoxifylline
patients takes captopril tablets 25 mg q8h and pentoxifylline 400 mg q8h
|
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).
Ages Eligible for Study: | 30 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Iran, Islamic Republic of, Fars | |
Shiraz University of Medical Sciences ,Nemazee and Faghihi Hospital | |
shiraz, Fars, Iran, Islamic Republic of, 0098 |
Study Chair: | Jamshid Roozbeh, MD | sums |
Study Director: | mohammad ghezloo, MD | SUMS |
Principal Investigator: | mohammad mahdi sagheb, MD | SUMS |
Principal Investigator: | Amin Banihashemi | SUMS |
Responsible Party: | SUMS ( shiraz university of medical sciences vice chancellor for research ) |
Study ID Numbers: | 3079 |
Study First Received: | April 21, 2008 |
Last Updated: | April 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00663949 History of Changes |
Health Authority: | Iran: Ethics Committee |
diabetes proteinuria pentoxifylline |
Captopril Vasodilator Agents Radiation-Protective Agents Antioxidants Diabetic Nephropathies Urination Disorders Diabetes Mellitus Endocrine System Diseases Cardiovascular Agents Antihypertensive Agents Pentoxifylline |
Protease Inhibitors Signs and Symptoms Proteinuria Phosphodiesterase Inhibitors Urologic Diseases Angiotensin-Converting Enzyme Inhibitors Platelet Aggregation Inhibitors Kidney Diseases Endocrinopathy Diabetes Complications |
Vasodilator Agents Radiation-Protective Agents Antioxidants Diabetic Nephropathies Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Hematologic Agents Pentoxifylline Signs and Symptoms Urologic Diseases Therapeutic Uses Free Radical Scavengers Angiotensin-Converting Enzyme Inhibitors Kidney Diseases Diabetes Complications |
Captopril Urination Disorders Diabetes Mellitus Endocrine System Diseases Enzyme Inhibitors Cardiovascular Agents Antihypertensive Agents Protective Agents Pharmacologic Actions Protease Inhibitors Urological Manifestations Proteinuria Phosphodiesterase Inhibitors Platelet Aggregation Inhibitors |