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NCT Number: NCT01382303

Effect of Pentoxifylline on Proteinuria in Korean Type 2 Diabetic Patients

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

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Proteinuria Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ajou University Hospital

Suwon, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pentoxifylline

Drug

Pentoxifylline 400mg three times a day

Other names: Trental

Placebo

Drug

placebo tablet three times a day

Primary outcomes

  1. Percentage Change in Proteinuia

    Time frame: baseline and 24 weeks

    Changes of urine protein to creatinie ratio from baseline to 24 weeks

Secondary outcomes

  1. Percentage Change in Albuminuria

    Time frame: baseline and 24 weeks

    Changes of urine albumin to creatinie ratio from baseline to 24 weeks

  2. Mean Change of eGFR

    Time frame: baseline and 24 weeks

    changes in eGFR from baseline to 24 weeks

  3. Mean Change of Creatinine

    Time frame: baseline and 24 weeks

    changes serum creatinine from baseline to 24 weeks

  4. Mean Change of Fasting Glucose

    Time frame: baseline and 24 weeks

    changes serum fasting glucose from baseline to 24 weeks

  5. Mean Change of TNF-a

    Time frame: baseline and 24 weeks

    changes in TNF-a from baseline to 24 weeks

Sponsors and collaborators

Lead sponsor

Ajou University School of Medicine

Other

Collaborators

  • Bundang CHA Hospital
  • Gangnam Severance Hospital
  • Hallym University Medical Center
  • Myongji Hospital
  • Yonsei University

Registry information

Official study title

Effect of Pentoxifylline on Proteinuria in Korean Type 2 Diabetic Patients : Prospective, Randomized, Double Blinded Active Control, Multicenter Study

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Jun 27, 2011
Registry last updated
Jun 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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