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

NCT00663949 | Completed Phase 2

• 1 other identifier: 3079
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetic Nephropathy

Keywords

diabetes; proteinuria; pentoxifylline

Outcome Measures

Primary Outcomes (1)

• decreasing urinary protein

  2 and 6 months

Study Arms (2)

A,1,II

ACTIVE COMPARATOR

patients in this arm takes 25 mg captopril q8h

Drug: Captopril

A,2,II

ACTIVE COMPARATOR

Drug: Captopril + Pentoxifylline

Interventions

Captopril DRUG

25 mg captopril tablet q8h

A,1,II

Captopril + Pentoxifylline DRUG

patients takes captopril tablets 25 mg q8h and pentoxifylline 400 mg q8h

A,2,II

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shiraz University of Medical Sciences: lead

Study Sites (1)

Shiraz University of Medical Sciences ,Nemazee and Faghihi Hospital

Shiraz, Fars, 0098, Iran

Location

MeSH Terms

Conditions

Diabetic Nephropathies; Diabetes Mellitus; Proteinuria

Interventions

Captopril; Pentoxifylline

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Urination Disorders; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Proline; Imino Acids; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Theobromine; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Jamshid Roozbeh, MD

  sums

  STUDY CHAIR

• mohammad ghezloo, MD

  SUMS

  STUDY DIRECTOR

• mohammad mahdi sagheb, MD

  SUMS

  PRINCIPAL INVESTIGATOR

• Amin Banihashemi

  SUMS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 21, 2008
• First Posted: April 22, 2008
• Study Start: February 1, 2006
• Primary Completion: December 1, 2007
• Study Completion: January 1, 2008
• Last Updated: April 22, 2008

Record last verified: 2008-03

Locations

IR (1)