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

This study has been completed.
Sponsor:
Information provided by:
Shiraz University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT00663949
First received: April 21, 2008
Last updated: NA
Last verified: March 2008
History: No changes posted
  Purpose

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 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 2 Trial of Effect of Combine Pentoxifylline and Captopril on Proteinuria in Diabetic Nephropathy

Resource links provided by NLM:


Further study details as provided by Shiraz University of Medical Sciences:

Primary Outcome Measures:
  • decreasing urinary protein [ Time Frame: 2 and 6 months ] [ Designated as safety issue: Yes ]

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
Active Comparator: A,1,II
patients in this arm takes 25 mg captopril q8h
Drug: Captopril
25 mg captopril tablet q8h
Active Comparator: A,2,II Drug: Captopril + Pentoxifylline
patients takes captopril tablets 25 mg q8h and pentoxifylline 400 mg q8h

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

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00663949

Locations
Iran, Islamic Republic of
Shiraz University of Medical Sciences ,Nemazee and Faghihi Hospital
Shiraz, Fars, Iran, Islamic Republic of, 0098
Sponsors and Collaborators
Shiraz University of Medical Sciences
Investigators
Study Chair: Jamshid Roozbeh, MD sums
Study Director: mohammad ghezloo, MD SUMS
Principal Investigator: mohammad mahdi sagheb, MD SUMS
Principal Investigator: Amin Banihashemi SUMS
  More Information

No publications provided

Responsible Party: shiraz university of medical sciences vice chancellor for research, SUMS
ClinicalTrials.gov Identifier: NCT00663949     History of Changes
Other Study ID Numbers: 3079
Study First Received: April 21, 2008
Last Updated: April 21, 2008
Health Authority: Iran: Ethics Committee

Keywords provided by Shiraz University of Medical Sciences:
diabetes
proteinuria
pentoxifylline

Additional relevant MeSH terms:
Diabetic Nephropathies
Kidney Diseases
Proteinuria
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Urination Disorders
Urological Manifestations
Signs and Symptoms
Captopril
Pentoxifylline
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Phosphodiesterase Inhibitors
Platelet Aggregation Inhibitors
Hematologic Agents
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs
Vasodilator Agents
Free Radical Scavengers
Antioxidants

ClinicalTrials.gov processed this record on July 28, 2014