Trial Outcomes & Findings for Effect of Pentoxifylline on Proteinuria in Korean Type 2 Diabetic Patients (NCT NCT01382303)

NCT ID: NCT01382303

Last Updated: 2017-06-16

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

174 participants

Primary outcome timeframe

baseline and 24 weeks

Results posted on

2017-06-16

Participant Flow

Participant milestones

Participant milestones
Measure	Pentoxifylline Pentoxifylline 400mg three times a day Pentoxifylline: Pentoxifylline 400mg three times a day	Placebo placebo tablet Placebo: placebo tablet three times a day
Overall Study STARTED	87	87
Overall Study COMPLETED	52	70
Overall Study NOT COMPLETED	35	17

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pentoxifylline n=87 Participants Pentoxifylline 400mg three times a day Pentoxifylline: Pentoxifylline 400mg three times a day	Placebo n=87 Participants placebo tablet Placebo: placebo tablet three times a day	Total n=174 Participants Total of all reporting groups
Age, Continuous	63.7 years STANDARD_DEVIATION 10.1 • n=87 Participants	63.8 years STANDARD_DEVIATION 9.4 • n=87 Participants	63.8 years STANDARD_DEVIATION 9 • n=174 Participants
Sex: Female, Male Female	40 Participants n=87 Participants	31 Participants n=87 Participants	71 Participants n=174 Participants
Sex: Female, Male Male	47 Participants n=87 Participants	56 Participants n=87 Participants	103 Participants n=174 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Korea, Republic of	87 participants n=87 Participants	87 participants n=87 Participants	174 participants n=174 Participants

PRIMARY outcome

Timeframe: baseline and 24 weeks

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

Outcome measures

Outcome measures
Measure	Pentoxifylline n=52 Participants Pentoxifylline 400mg three times a day Pentoxifylline: Pentoxifylline 400mg three times a day	Placebo n=70 Participants placebo tablet Placebo: placebo tablet three times a day
Percentage Change in Proteinuia	-23 % change from baseline Interval -50.0 to 10.0	-4 % change from baseline Interval -30.0 to 40.0

SECONDARY outcome

Timeframe: baseline and 24 weeks

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

Outcome measures

Outcome measures
Measure	Pentoxifylline n=52 Participants Pentoxifylline 400mg three times a day Pentoxifylline: Pentoxifylline 400mg three times a day	Placebo n=70 Participants placebo tablet Placebo: placebo tablet three times a day
Percentage Change in Albuminuria	-10 % change from baseline Interval -47.0 to 50.0	-6 % change from baseline Interval -45.0 to 41.0

SECONDARY outcome

Timeframe: baseline and 24 weeks

changes in eGFR from baseline to 24 weeks

Outcome measures

Outcome measures
Measure	Pentoxifylline n=52 Participants Pentoxifylline 400mg three times a day Pentoxifylline: Pentoxifylline 400mg three times a day	Placebo n=70 Participants placebo tablet Placebo: placebo tablet three times a day
Mean Change of eGFR	-1.05 ml/min per 1.73m2 Standard Deviation 18.20	-3.59 ml/min per 1.73m2 Standard Deviation 14.20

SECONDARY outcome

Timeframe: baseline and 24 weeks

changes serum creatinine from baseline to 24 weeks

Outcome measures

Outcome measures
Measure	Pentoxifylline n=52 Participants Pentoxifylline 400mg three times a day Pentoxifylline: Pentoxifylline 400mg three times a day	Placebo n=70 Participants placebo tablet Placebo: placebo tablet three times a day
Mean Change of Creatinine	0.03 mg/dL Standard Deviation 0.16	0.04 mg/dL Standard Deviation 0.15

SECONDARY outcome

Timeframe: baseline and 24 weeks

changes serum fasting glucose from baseline to 24 weeks

Outcome measures

Outcome measures
Measure	Pentoxifylline n=52 Participants Pentoxifylline 400mg three times a day Pentoxifylline: Pentoxifylline 400mg three times a day	Placebo n=70 Participants placebo tablet Placebo: placebo tablet three times a day
Mean Change of Fasting Glucose	-10.0 mg/dL Standard Deviation 38.9	8.4 mg/dL Standard Deviation 37.4

SECONDARY outcome

Timeframe: baseline and 24 weeks

changes in TNF-a from baseline to 24 weeks

Outcome measures

Outcome measures
Measure	Pentoxifylline n=52 Participants Pentoxifylline 400mg three times a day Pentoxifylline: Pentoxifylline 400mg three times a day	Placebo n=70 Participants placebo tablet Placebo: placebo tablet three times a day
Mean Change of TNF-a	-0.24 pg/mL Standard Deviation 3.11	0.14 pg/mL Standard Deviation 0.71

Adverse Events

Pentoxifylline

Serious events: 0 serious events

Other events: 20 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Pentoxifylline n=87 participants at risk Pentoxifylline 400mg three times a day Pentoxifylline: Pentoxifylline 400mg three times a day	Placebo n=87 participants at risk placebo tablet Placebo: placebo tablet three times a day
Gastrointestinal disorders dyspepsia	8.0% 7/87	1.1% 1/87
Gastrointestinal disorders nasea	5.7% 5/87	2.3% 2/87
Gastrointestinal disorders gastric reflux	5.7% 5/87	3.4% 3/87
Vascular disorders headache	3.4% 3/87	1.1% 1/87

Additional Information

Kwan Woo Lee

Ajou University

Phone: 82-31-219-4526

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place