Effect of Pentoxifylline on Proteinuria in Korean Type 2 Diabetic Patients

Phase 4

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: Placebo; Drug: Pentoxifylline

• Registration Number: NCT01382303
• Lead Sponsor: Ajou University School of Medicine

Brief Summary

This multi-center, randomized controlled study aims to evaluate the effects of pentoxifylline on proteinuria in Korean type 2 diabetic patients.

Detailed Description

The investigators will recruit adults patients with type 2 diabetes aged over 20 years with spot urine albumin to creatinine ratio over 30mg/g in two consecutive measurements.

Enrolled patients will be randomly assigned to receive pentoxifylline (400mg three times daily) or placebo for 24 weeks.

Fasting blood and spot urine will be collected at baseline, 12 weeks and 24 weeks.

The investigators will evaluate the impact of pentoxifylline on proteinuria in type 2 diabetic patients.

Study Timeline

• Study Start: 2010-10-25
• Study First Submitted: 2011-06-22
• Study First Submitted QC: 2011-06-24
• Study First Posted: 2011-06-27
• Primary Completion: 2013-12-20
• Study Completion: 2013-12-20
• Results First Submitted: 2017-02-13
• Status Verified: 2017-03
• Results First Submitted QC: 2017-03-31
• Last Update Submitted: 2017-03-31
• Results First Posted: 2017-06-16
• Last Update Posted: 2017-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 174

Inclusion Criteria

• type 2 diabetes mellitus
• age >=20 years
• spot urine albumin/creatinine ratio > 30mg/g in two consecutive measurements
• patients on ACE-inhibitor or ARB as an anti-hypertensive drug
• blood pressure <= 150/100 mmHg
• HbA1c <10%

Exclusion Criteria

• taking insulin pentoxifylline, cilostazol, ketas, viagra in 3 months
• ischemic heart disease, stroke, malignant disease, severe infection in 6 months
• serum creatinine > 2.0mg/dl
• severe liver disease or AST, ALT > 3* ULM
• taking systemic steroid in 1 month
• pregnant or plan to become pregnant during the clinical trial
• lactation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	placebo tablet
Pentoxifylline	Pentoxifylline	Pentoxifylline 400mg three times a day

Primary Outcome Measures

Name	Time	Method
Percentage Change in Proteinuia	baseline and 24 weeks	Changes of urine protein to creatinie ratio from baseline to 24 weeks

Secondary Outcome Measures

Name	Time	Method
Percentage Change in Albuminuria	baseline and 24 weeks	Changes of urine albumin to creatinie ratio from baseline to 24 weeks
Mean Change of Fasting Glucose	baseline and 24 weeks	changes serum fasting glucose from baseline to 24 weeks
Mean Change of TNF-a	baseline and 24 weeks	changes in TNF-a from baseline to 24 weeks
Mean Change of Creatinine	baseline and 24 weeks	changes serum creatinine from baseline to 24 weeks
Mean Change of eGFR	baseline and 24 weeks	changes in eGFR from baseline to 24 weeks

Trial Locations

Locations (1)

Ajou University Hospital; 🇰🇷 Suwon, Korea, Republic of