Effect of Pentoxifylline on Proteinuria in Korean Type 2 Diabetic Patients
NCT ID: NCT01382303
Last Updated: 2017-06-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
174 participants
INTERVENTIONAL
2010-10-25
2013-12-20
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Pentoxifylline
Pentoxifylline 400mg three times a day
Pentoxifylline
Pentoxifylline 400mg three times a day
Placebo
placebo tablet
Placebo
placebo tablet three times a day
Interventions
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Pentoxifylline
Pentoxifylline 400mg three times a day
Placebo
placebo tablet three times a day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
80 Years
ALL
No
Sponsors
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Bundang CHA Hospital
OTHER
Hallym University Medical Center
OTHER
Gangnam Severance Hospital
OTHER
Yonsei University
OTHER
Myongji Hospital
OTHER
Ajou University School of Medicine
OTHER
Responsible Party
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Kwan Woo Lee
professor
Principal Investigators
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Kwan-Woo Lee, PhD
Role: PRINCIPAL_INVESTIGATOR
Ajou University School of Medicine
Locations
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Ajou University Hospital
Suwon, , South Korea
Countries
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References
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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.
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.
Other Identifiers
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AJIRB-MED-CT4-10-055
Identifier Type: -
Identifier Source: org_study_id
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