| April 21, 2008 |
| April 21, 2008 |
| February 2006 |
| December 2007 (final data collection date for primary outcome measure) |
| decreasing urinary protein [ Time Frame: 2 and 6 months ] [ Designated as safety issue: Yes ] |
| Same as current |
| No Changes Posted |
| |
| |
| |
| 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 |
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. |
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). |
| Phase II, Phase III |
| Interventional |
| Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Diabetic Nephropathy |
- Drug: Captopril
- Drug: Captopril + Pentoxifylline
|
| Active Comparator: patients in this arm takes 25 mg captopril q8h |
| |
| |
| Completed |
| 70 |
| January 2008 |
| December 2007 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Absence of kidney or urinary tract disease
- Absence of high blood pressure OR Controlled blood pressure (≤140/90) with medication other than ACE inhibitors and/or non dihydropyridine calcium channel blockers
- A well controlled blood sugar level (HbA1c≤7.5%)
- Adhering to the diet protocol for patients with renal disease
Exclusion Criteria:
- NYHA functional class III, IV
- Valvular heart disease
- Unstable angina, myocardial infarction, cerebrovascular accidents
- Psychiatric disease
- Prior allograft kidney transplant
- Acute illness
- Infectious disease including urinary tract infection
- Leukocytosis or any febrile illness at enrollment
- Prior history or development of any form of malignancy
- History of alcohol or drug abuse or smoking
- Pregnancy
- Need for surgery during the study
- Allergy to derivatives of methyl xanthines
- Current Pentoxyphilline use
|
| Both |
| 30 Years to 70 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Iran, Islamic Republic of |
| |
| NCT00663949 |
| shiraz university of medical sciences vice chancellor for research, SUMS |
| 3079 |
| Shiraz University of Medical Sciences |
|
| Study Chair: |
Jamshid Roozbeh, MD |
sums |
|
| Study Director: |
mohammad ghezloo, MD |
SUMS |
|
| Principal Investigator: |
mohammad mahdi sagheb, MD |
SUMS |
|
| Principal Investigator: |
Amin Banihashemi |
SUMS |
|
|
| Shiraz University of Medical Sciences |
| March 2008 |