Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Bundang CHA Hospital | OTHER |
| Hallym University Medical Center | OTHER |
| Gangnam Severance Hospital | OTHER |
| Yonsei University |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This multi-center, randomized controlled study aims to evaluate the effects of pentoxifylline on proteinuria in Korean type 2 diabetic patients.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pentoxifylline | Active Comparator | Pentoxifylline 400mg three times a day |
|
| Placebo | Placebo Comparator | placebo tablet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pentoxifylline | Drug | Pentoxifylline 400mg three times a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change in Proteinuia | Changes of urine protein to creatinie ratio from baseline to 24 weeks | baseline and 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change in Albuminuria | Changes of urine albumin to creatinie ratio from baseline to 24 weeks | baseline and 24 weeks |
| Mean Change of eGFR | changes in eGFR from baseline to 24 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kwan-Woo Lee, PhD | Ajou University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ajou University Hospital | Suwon | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37916745 | Derived | 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. | |
| 26300986 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Pentoxifylline | Pentoxifylline 400mg three times a day Pentoxifylline: Pentoxifylline 400mg three times a day |
| FG001 | Placebo | placebo tablet Placebo: placebo tablet three times a day |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Pentoxifylline | Pentoxifylline 400mg three times a day Pentoxifylline: Pentoxifylline 400mg three times a day |
| BG001 | Placebo | placebo tablet Placebo: placebo tablet three times a day |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage Change in Proteinuia | Changes of urine protein to creatinie ratio from baseline to 24 weeks | Posted | Mean | Inter-Quartile Range | % change from baseline | baseline and 24 weeks |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pentoxifylline | Pentoxifylline 400mg three times a day Pentoxifylline: Pentoxifylline 400mg three times a day |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| dyspepsia | Gastrointestinal disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kwan Woo Lee | Ajou University | 82-31-219-4526 | LKW65@ajou.ac.kr |
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D011507 | Proteinuria |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D010431 | Pentoxifylline |
| ID | Term |
|---|---|
| D013805 | Theobromine |
| D014970 | Xanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 |
Not provided
Not provided
| OTHER |
| Myongji Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | placebo tablet three times a day |
|
| baseline and 24 weeks |
| Mean Change of Creatinine | changes serum creatinine from baseline to 24 weeks | baseline and 24 weeks |
| Mean Change of Fasting Glucose | changes serum fasting glucose from baseline to 24 weeks | baseline and 24 weeks |
| Mean Change of TNF-a | changes in TNF-a from baseline to 24 weeks | baseline and 24 weeks |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Secondary | Percentage Change in Albuminuria | Changes of urine albumin to creatinie ratio from baseline to 24 weeks | Posted | Mean | Inter-Quartile Range | % change from baseline | baseline and 24 weeks |
|
|
|
| Secondary | Mean Change of eGFR | changes in eGFR from baseline to 24 weeks | Posted | Mean | Standard Deviation | ml/min per 1.73m2 | baseline and 24 weeks |
|
|
|
| Secondary | Mean Change of Creatinine | changes serum creatinine from baseline to 24 weeks | Posted | Mean | Standard Deviation | mg/dL | baseline and 24 weeks |
|
|
|
| Secondary | Mean Change of Fasting Glucose | changes serum fasting glucose from baseline to 24 weeks | Posted | Mean | Standard Deviation | mg/dL | baseline and 24 weeks |
|
|
|
| Secondary | Mean Change of TNF-a | changes in TNF-a from baseline to 24 weeks | Posted | Mean | Standard Deviation | pg/mL | baseline and 24 weeks |
|
|
|
| 0 |
| 87 |
| 20 |
| 87 |
| EG001 | Placebo | placebo tablet Placebo: placebo tablet three times a day | 0 | 87 | 3 | 87 |
| nasea | Gastrointestinal disorders | Non-systematic Assessment |
|
| gastric reflux | Gastrointestinal disorders | Non-systematic Assessment |
|
| headache | Vascular disorders | Non-systematic Assessment |
|
Not provided
Not provided
| D004700 | Endocrine System Diseases |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |