Effect of Pentoxifylline on Proteinuria in Korean Type 2 Diabetic Patients

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01382303

Enrollment

174

Registered

2011-06-27

Start date

2010-10-25

Completion date

2013-12-20

Last updated

2017-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Keywords

Type 2 Diabetes, pentoxifylline, proteinuria

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.

Interventions

DRUGPentoxifylline

Pentoxifylline 400mg three times a day

DRUGPlacebo

placebo tablet three times a day

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Percentage Change in Albuminuria	baseline and 24 weeks	Changes of urine albumin to creatinie ratio from baseline to 24 weeks
Mean Change of eGFR	baseline and 24 weeks	changes in eGFR from baseline to 24 weeks
Mean Change of Creatinine	baseline and 24 weeks	changes serum creatinine 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

Countries

South Korea

Participant flow

Participants by arm

Arm	Count
Pentoxifylline Pentoxifylline 400mg three times a day Pentoxifylline: Pentoxifylline 400mg three times a day	87
Placebo placebo tablet Placebo: placebo tablet three times a day	87
Total	174

Baseline characteristics

Characteristic	Placebo	Total	Pentoxifylline
Age, Continuous	63.8 years STANDARD_DEVIATION 9.4	63.8 years STANDARD_DEVIATION 9	63.7 years STANDARD_DEVIATION 10.1
Race and Ethnicity Not Collected	—	0 Participants	—
Region of Enrollment Korea, Republic of	87 participants	174 participants	87 participants
Sex: Female, Male Female	31 Participants	71 Participants	40 Participants
Sex: Female, Male Male	56 Participants	103 Participants	47 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	20 / 87	3 / 87
serious Total, serious adverse events	0 / 87	0 / 87