Clinical Trials Logo
  1. Home
  2. Chronic Kidney Disease (CKD)
  3. NCT03226899

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

Gout Clinical Trial

Official title:
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

Clinical Trial 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).

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03226899
Study type Interventional
Source Ironwood Pharmaceuticals, Inc.
Contact
Status Terminated
Phase Phase 4
Start date July 19, 2017
Completion date February 25, 2019
View Details
See also
  Status Clinical Trial Phase
Completed NCT04060173 - A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ABP-671 Phase 1
Not yet recruiting NCT06187519 - UR+AIMS Gout Wearable Skin Uric Acid Monitor Study N/A
Completed NCT03635957 - Study of Pegloticase (KRYSTEXXA®) Plus Methotrexate in Patients With Uncontrolled Gout Phase 4
Completed NCT04966325 - Thorough QT (TQT) Study to Evaluate the Effect of LC350189 on Cardiac Repolarization in Healthy Male and Female Subjects Early Phase 1
Completed NCT03015948 - A Single Dose Study of SHR4640 in Healthy Male Volunteers Phase 1
Completed NCT02855437 - Novel Methods for Ascertainment of Gout Flares -A Pilot Study N/A
Active, not recruiting NCT02702375 - Meta-analyses of Impotrant Food Sources of Sugars and Incident Cardiometabolic Diseases N/A
Completed NCT01407874 - A Randomized, Double-Blind, Dose-Response Study of the Safety and Uric Acid Effects of Oral Ulodesine Added to Allopurinol in Subjects With Gout and Concomitant Moderate Renal Insufficiency Phase 2
Completed NCT00995618 - Study of Tranilast Alone or in Combination With Febuxostat in Patients With Hyperuricemia Phase 2
Completed NCT00985127 - Study to Evaluate the Urate-Lowering Activity and Safety of Oral BCX4208 Administered in Subjects With Gout Phase 2
Terminated NCT04987294 - Phase IIa Study of ALLN-346 (Engineered Urate Oxidase) in Subjects With Hyperuricemia, Gout and Chronic Kidney Disease Phase 2
Completed NCT03291782 - D-0120 Safety and PK/PD, Food Effect Study in Healthy Volunteers Phase 1
Recruiting NCT03388515 - A Study to Assess the Safety and Tolerability of SSS11 in Healthy Subjects. Phase 1
Completed NCT06189404 - Effect of Tigulixostat on the Pharmacokinetics of Theophylline Phase 1
Enrolling by invitation NCT03336203 - The Impact of Urate-lowering Therapy on Kidney Function (IMPULsKF) Phase 4
Recruiting NCT05586958 - Tigulixostat, Phase 3 Study, Placebo Controlled in Gout Patients Phase 3
Recruiting NCT04047394 - A Study to Determine the Safety, Tolerability, PK and Preliminary PD of SSS11 in Chinese Healthy Adult Volunteers Phase 1
Not yet recruiting NCT05507723 - Tight Control of Gouty Arthritis Compared to Usual Care N/A
Recruiting NCT06056570 - Open Label PK, PD and DDI of Dotinurad and Allopurinol in Gout Patients With Hyperuricemia Phase 1/Phase 2
Completed NCT02557126 - Study of URC102 to Assess the Safety and Efficacy in Gout Patients Phase 2