NCT01382303

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
174

participants targeted

Target at P75+ for phase_4 type-2-diabetes

Timeline
Completed

Started Oct 2010

Typical duration for phase_4 type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 25, 2010

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 22, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 27, 2011

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2013

Completed
3.5 years until next milestone

Results Posted

Study results publicly available

June 16, 2017

Completed
Last Updated

June 16, 2017

Status Verified

March 1, 2017

Enrollment Period

3.2 years

First QC Date

June 22, 2011

Results QC Date

February 13, 2017

Last Update Submit

March 31, 2017

Conditions

Type 2 Diabetes

Keywords

Type 2 Diabetespentoxifyllineproteinuria

Outcome Measures

Primary Outcomes (1)

  • Percentage Change in Proteinuia

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

    baseline and 24 weeks

Secondary Outcomes (5)

  • Percentage Change in Albuminuria

    baseline and 24 weeks

  • Mean Change of eGFR

    baseline and 24 weeks

  • Mean Change of Creatinine

    baseline and 24 weeks

  • Mean Change of Fasting Glucose

    baseline and 24 weeks

  • Mean Change of TNF-a

    baseline and 24 weeks

Study Arms (2)

Pentoxifylline

ACTIVE COMPARATOR

Pentoxifylline 400mg three times a day

Drug: Pentoxifylline

Placebo

PLACEBO COMPARATOR

placebo tablet

Drug: Placebo

Interventions

PentoxifyllineDRUG

Pentoxifylline 400mg three times a day

Also known as: Trental
Pentoxifylline
PlaceboDRUG

placebo tablet three times a day

Placebo

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ajou University Hospital

Suwon, South Korea

Location

Related Publications (2)

  • Colombijn JM, Hooft L, Jun M, Webster AC, Bots ML, Verhaar MC, Vernooij RW. Antioxidants for adults with chronic kidney disease. Cochrane Database Syst Rev. 2023 Nov 2;11(11):CD008176. doi: 10.1002/14651858.CD008176.pub3.

    PMID: 37916745DERIVED

  • Han SJ, Kim HJ, Kim DJ, Sheen SS, Chung CH, Ahn CW, Kim SH, Cho YW, Park SW, Kim SK, Kim CS, Kim KW, Lee KW. Effects of pentoxifylline on proteinuria and glucose control in patients with type 2 diabetes: a prospective randomized double-blind multicenter study. Diabetol Metab Syndr. 2015 Jul 19;7:64. doi: 10.1186/s13098-015-0060-1. eCollection 2015.

    PMID: 26300986DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Proteinuria

Interventions

Pentoxifylline

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TheobromineXanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title
Kwan Woo Lee
Organization
Ajou University
LKW65@ajou.ac.kr
82-31-219-4526

Study Officials

  • Kwan-Woo Lee, PhD

    Ajou University School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

June 22, 2011

First Posted

June 27, 2011

Study Start

October 25, 2010

Primary Completion

December 20, 2013

Study Completion

December 20, 2013

Last Updated

June 16, 2017

Results First Posted

June 16, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)