CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 80 enrolled
Drug / intervention
Febuxostat +1 moredrug
Likely dose
Febuxostat 80 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01350388
NCT01350388N/ACompleted

Effects of Febuxostat on Adipokines and Kidney Disease in Diabetic Chronic Kidney Disease

University of Utah·interventional·Posted May 9, 2011·Updated Oct 3, 2016

In Brief

A clinical study evaluating Febuxostat and Placebo for Chronic Kidney Disease and Diabetes. Completed, enrolled 80 participants across 1 site.

Detailed Summary

Hyperuricemia is emerging as a risk factor for development of diabetes and metabolic syndrome. Recently, it was shown in in-vitro cell culture experiments that hyperuricemia induces redox-dependent signaling and oxidative stress in adipocytes. By targeting levels of uric acid with febuxostat it is hypothesized that the levels of oxidative stress in adipose tissue (obtained by fat biopsy) will decrease. Primary aims of the study are to determine whether febuxostat therapy in overweight or obese, diabetic patients with stage 3 Chronic Kidney Disease (CKD) and high serum uric acid levels 1. will affect adipose tissue concentrations of thiobarbituric acid reactive substance (TBARS), a marker of oxidative stress 2. will affect adipose tissue expression and concentrations of adiponectin; and 3. will affect urinary concentrations of transforming growth factor (TGF)- B1.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsTakeda

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMay 9, 2011
Enrollment StartMay 1, 2011
Primary CompletionOct 1, 2013
Study CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 15.1 years ago

Interventions

Febuxostatdrug

80 mg/day of febuxostat for 24 weeks

Placebodrug

1 placebo tablet per day for 24 weeks