CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 96 enrolled
Drug / intervention
Febuxostat +1 moredrug
Likely dose
Not stated in 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/NCT01082640
NCT01082640Phase 2Completed
CompareCT.gov

A Multicenter, Randomized, Double-Blind, Phase 2 Study to Evaluate the Effect of Febuxostat Versus Placebo on Renal Function in Gout Subjects With Hyperuricemia and Moderate to Severe Renal Impairment

Takeda·interventional·Posted Mar 8, 2010·Updated Sep 25, 2013

In Brief

A Phase 2 clinical trial evaluating Febuxostat and Placebo for Renal Impairment. Completed, enrolled 96 participants across 58 sites.

Detailed Summary

The purpose of this study is to determine the effect of febuxostat, once daily (QD) or twice daily (BID), on renal function in gout patients with elevated serum urate levels and who have moderate to severe renal impairment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRenal Impairment
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 8, 2010
Enrollment StartApr 1, 2010
Primary CompletionMay 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 16.3 years ago

Interventions

Febuxostatdrug

Febuxostat capsules

Placebodrug

Febuxostat placebo-matching capsules