Effect of Pentoxifylline on Proteinuria in Korean Type 2 Diabetic Patients

• Sponsor: Ajou University School of Medicine (Other)
• Overall Status: Completed
• CT.gov ID: NCT01382303
• Collaborator: Bundang CHA Hospital (Other), Hallym University Medical Center (Other), Gangnam Severance Hospital (Other), Yonsei University (Other), Myongji Hospital (Other)
• Enrollment: 174
• Location: 1
• Arms: 2
• Actual Duration (Months): 37.8
• Patients Per Site Per Month: 4.6

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes	Drug: Pentoxifylline; Drug: Placebo	Phase 4

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 Design

• Study Type: Interventional
• Actual Enrollment: 174 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Effect of Pentoxifylline on Proteinuria in Korean Type 2 Diabetic Patients : Prospective, Randomized, Double Blinded Active Control, Multicenter Study
• Actual Study Start Date: Oct 25, 2010
• Actual Primary Completion Date: Dec 20, 2013
• Actual Study Completion Date: Dec 20, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Pentoxifylline Pentoxifylline 400mg three times a day	Drug: Pentoxifylline; Pentoxifylline 400mg three times a day; Other Names: Trental
Placebo Comparator: Placebo placebo tablet	Drug: Placebo; placebo tablet three times a day

Outcome Measures

Primary Outcome Measures

1. Percentage Change in Proteinuia [baseline and 24 weeks]

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

Secondary Outcome Measures

1. Percentage Change in Albuminuria [baseline and 24 weeks]

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

2. Mean Change of eGFR [baseline and 24 weeks]

   changes in eGFR from baseline to 24 weeks

3. Mean Change of Creatinine [baseline and 24 weeks]

   changes serum creatinine from baseline to 24 weeks

4. Mean Change of Fasting Glucose [baseline and 24 weeks]

   changes serum fasting glucose from baseline to 24 weeks

5. Mean Change of TNF-a [baseline and 24 weeks]

   changes in TNF-a from baseline to 24 weeks

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ajou University Hospital	Suwon		Korea, Republic of

Sponsors and Collaborators

• Ajou University School of Medicine
• Bundang CHA Hospital
• Hallym University Medical Center
• Gangnam Severance Hospital
• Yonsei University
• Myongji Hospital

Investigators

• Principal Investigator: Kwan-Woo Lee, PhD, Ajou University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kwan Woo Lee, professor, Ajou University School of Medicine
• ClinicalTrials.gov Identifier: NCT01382303
• Other Study ID Numbers: AJIRB-MED-CT4-10-055
• First Posted: Jun 27, 2011
• Last Update Posted: Jun 16, 2017
• Last Verified: Mar 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Kwan Woo Lee, professor, Ajou University School of Medicine: Type 2 Diabetes; pentoxifylline; proteinuria
• Additional relevant MeSH terms: Proteinuria; Diabetes Mellitus, Type 2; Pentoxifylline

Study Results

Participant Flow

Arm/Group Title	Pentoxifylline	Placebo
Arm/Group Description	Pentoxifylline 400mg three times a day Pentoxifylline: Pentoxifylline 400mg three times a day	placebo tablet Placebo: placebo tablet three times a day
Period Title: Overall Study
STARTED	87	87
COMPLETED	52	70
NOT COMPLETED	35	17

Baseline Characteristics

Arm/Group Title	Pentoxifylline	Placebo	Total
Arm/Group Description	Pentoxifylline 400mg three times a day Pentoxifylline: Pentoxifylline 400mg three times a day	placebo tablet Placebo: placebo tablet three times a day	Total of all reporting groups
Overall Participants	87	87	174
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	63.7 (10.1)	63.8 (9.4)	63.8 (9)
Sex: Female, Male (Count of Participants)
Female	40 46%	31 35.6%	71 40.8%
Male	47 54%	56 64.4%	103 59.2%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
Korea, Republic of	87 100%	87 100%	174 100%

Outcome Measures

1. Primary Outcome

Title	Percentage Change in Proteinuia
Description	Changes of urine protein to creatinie ratio from baseline to 24 weeks
Time Frame	baseline and 24 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pentoxifylline	Placebo
Arm/Group Description	Pentoxifylline 400mg three times a day Pentoxifylline: Pentoxifylline 400mg three times a day	placebo tablet Placebo: placebo tablet three times a day
Measure Participants	52	70
Mean (Inter-Quartile Range) [% change from baseline]	-23	-4

2. Secondary Outcome

Title	Percentage Change in Albuminuria
Description	Changes of urine albumin to creatinie ratio from baseline to 24 weeks
Time Frame	baseline and 24 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pentoxifylline	Placebo
Arm/Group Description	Pentoxifylline 400mg three times a day Pentoxifylline: Pentoxifylline 400mg three times a day	placebo tablet Placebo: placebo tablet three times a day
Measure Participants	52	70
Mean (Inter-Quartile Range) [% change from baseline]	-10	-6

3. Secondary Outcome

Title	Mean Change of eGFR
Description	changes in eGFR from baseline to 24 weeks
Time Frame	baseline and 24 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pentoxifylline	Placebo
Arm/Group Description	Pentoxifylline 400mg three times a day Pentoxifylline: Pentoxifylline 400mg three times a day	placebo tablet Placebo: placebo tablet three times a day
Measure Participants	52	70
Mean (Standard Deviation) [ml/min per 1.73m2]	-1.05 (18.20)	-3.59 (14.20)

4. Secondary Outcome

Title	Mean Change of Creatinine
Description	changes serum creatinine from baseline to 24 weeks
Time Frame	baseline and 24 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pentoxifylline	Placebo
Arm/Group Description	Pentoxifylline 400mg three times a day Pentoxifylline: Pentoxifylline 400mg three times a day	placebo tablet Placebo: placebo tablet three times a day
Measure Participants	52	70
Mean (Standard Deviation) [mg/dL]	0.03 (0.16)	0.04 (0.15)

5. Secondary Outcome

Title	Mean Change of Fasting Glucose
Description	changes serum fasting glucose from baseline to 24 weeks
Time Frame	baseline and 24 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pentoxifylline	Placebo
Arm/Group Description	Pentoxifylline 400mg three times a day Pentoxifylline: Pentoxifylline 400mg three times a day	placebo tablet Placebo: placebo tablet three times a day
Measure Participants	52	70
Mean (Standard Deviation) [mg/dL]	-10.0 (38.9)	8.4 (37.4)

6. Secondary Outcome

Title	Mean Change of TNF-a
Description	changes in TNF-a from baseline to 24 weeks
Time Frame	baseline and 24 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pentoxifylline	Placebo
Arm/Group Description	Pentoxifylline 400mg three times a day Pentoxifylline: Pentoxifylline 400mg three times a day	placebo tablet Placebo: placebo tablet three times a day
Measure Participants	52	70
Mean (Standard Deviation) [pg/mL]	-0.24 (3.11)	0.14 (0.71)

Adverse Events

Arm/Group Title	Pentoxifylline		Placebo
Arm/Group Description	Pentoxifylline 400mg three times a day Pentoxifylline: Pentoxifylline 400mg three times a day		placebo tablet Placebo: placebo tablet three times a day
All Cause Mortality
	Pentoxifylline		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Pentoxifylline		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/87 (0%)		0/87 (0%)
Other (Not Including Serious) Adverse Events
	Pentoxifylline		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	20/87 (23%)		3/87 (3.4%)
Gastrointestinal disorders
dyspepsia	7/87 (8%)		1/87 (1.1%)
nasea	5/87 (5.7%)		2/87 (2.3%)
gastric reflux	5/87 (5.7%)		3/87 (3.4%)
Vascular disorders
headache	3/87 (3.4%)		1/87 (1.1%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.