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

Sponsored by:	Shiraz University of Medical Sciences
Information provided by:	Shiraz University of Medical Sciences
ClinicalTrials.gov Identifier:	NCT00663949

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 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

Resource links provided by NLM:

MedlinePlus related topics: Diabetic Kidney Problems

Drug Information available for: Captopril Pentoxyl Pentoxifylline

U.S. FDA Resources

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
A,1,II: Active Comparator patients in this arm takes 25 mg captopril q8h	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

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:

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

Contacts and Locations

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

Locations

Iran, Islamic Republic of, Fars
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:	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

Keywords provided by Shiraz University of Medical Sciences:

diabetes
proteinuria
pentoxifylline

Study placed in the following topic categories:

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

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on July 02, 2009