Phase 4
N=174
Effect of Pentoxifylline on Proteinuria in Korean Type 2 Diabetic Patients
Type 2 Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT01382303 ↗Enrolled (actual)
174
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcome: Primary: Percentage Change in Proteinuia — -23; -4 % change from baseline
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Pentoxifylline (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Ajou University School of Medicine
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Change in Proteinuia |
-23; -4 | — |
| SECONDARY Percentage Change in Albuminuria |
-10; -6 | — |
| SECONDARY Mean Change of eGFR |
-1.05; -3.59 | — |
| SECONDARY Mean Change of Creatinine |
0.03; 0.04 | — |
| SECONDARY Mean Change of Fasting Glucose |
-10.0; 8.4 | — |
| SECONDARY Mean Change of TNF-a |
-0.24; 0.14 | — |
Summary
This multi-center, randomized controlled study aims to evaluate the effects of pentoxifylline on proteinuria in Korean type 2 diabetic patients.
Eligibility Criteria
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 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
Data sourced from ClinicalTrials.gov (NCT01382303). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.