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

Diabetic Nephropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00663949
• Other study ID #: 3079
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: April 21, 2008
• Last updated: April 21, 2008
• Start date: February 2006
• Est. completion date: January 2008

Study information

• Verified date: March 2008
• Source: Shiraz University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: January 2008
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 70 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Diabetic Nephropathies
• Diabetic Nephropathy
• Kidney Diseases
• Proteinuria

Intervention

Drug:
• Captopril
25 mg captopril tablet q8h
• Captopril + Pentoxifylline
patients takes captopril tablets 25 mg q8h and pentoxifylline 400 mg q8h

Locations

Country	Name	City	State
Iran, Islamic Republic of	Shiraz University of Medical Sciences ,Nemazee and Faghihi Hospital	Shiraz	Fars

Sponsors (1)

Lead Sponsor	Collaborator
Shiraz University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	decreasing urinary protein		2 and 6 months	Yes