NCT03226899

A Phase 4 Safety and Efficacy Study to Evaluate Lesinurad 200 mg in Participants With Gout and Renal Impairment

A Phase 4, Study to Evaluate the Safety and Efficacy of Lesinurad 200 mg in Combination With a Xanthine Oxidase Inhibitor (XOI), Compared With an XOI Alone, in Subjects With Gout and Estimated Creatinine Clearance (eCrCl) 30 to <60 mL/Min Who Have Not Achieved Target Serum Uric Acid Levels (sUA) on an XOI Alone

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 242 (actual)
• Sponsor: Ironwood Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the safety and efficacy of lesinurad administered with an XOI versus a placebo plus an XOI in gout participants who have moderate renal impairment and who are not at target level of serum urate (sUA).

Detailed description

This postmarketing study is a randomized, double-blind, placebo-controlled study to evaluate safety (with particular focus on renal and cardiovascular events) and efficacy of lesinurad 200 mg once daily (QD) in combination with an XOI for up to 24 months compared with XOI monotherapy, in participants with gout and moderate renal impairment who have not reached target sUA levels (\<6.0 mg/dL) on an XOI alone.

Conditions

• Gout
• Chronic Kidney Disease (CKD)

Interventions

Type	Name	Description
DRUG	Lesinurad	200 mg oral tablet
DRUG	XOI	All participants must be on a stable, medically appropriate dose of XOI as their sole urate-lowering therapy (ULT) indicated for the treatment of gout for at least 4 weeks prior to Screening and throughout the Screening Period. This stable dose of XOI will be maintained throughout the study period.
DRUG	Placebo	matching placebo oral tablet
DRUG	colchicine	Gout flare prophylaxis: commercially available colchicine is provided through the Month 6 study visit. Actual colchicine dose (0.5 or 0.6 mg qd) and frequency were adjusted based on the local label, subject medical history, and clinical judgement.
DRUG	corticosteroids	Gout flare prophylaxis: Participants unable to take colchicine are permitted to take a short course of low-dose oral corticosteroids up to the Month 3 study visit

Timeline

• Start date: 2017-07-19
• Primary completion: 2019-02-25
• Completion: 2019-02-25
• First posted: 2017-07-24
• Last updated: 2021-11-04
• Results posted: 2021-11-04

Locations

116 sites across 4 countries: United States, Czechia, Hungary, Poland

Regulatory

• FDA-regulated drug study