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
Information obtained from ClinicalTrials.gov on June 20, 2008
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: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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
Ending date: January 2008
Last updated: April 21, 2008
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