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Terminated Phase 4 Interventional Results available

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

ClinicalTrials.gov ID: NCT03226899

Public ClinicalTrials.gov record NCT03226899. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 22, 2026, 7:28 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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).

Study identification

NCT ID
NCT03226899
Recruitment status
Terminated
Study type
Interventional
Phase
Phase 4
Lead sponsor
Ironwood Pharmaceuticals, Inc.
Industry
Enrollment
242 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 85 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 19, 2017 (Actual)
Primary completion
Feb 25, 2019 (Actual)
Completion
Feb 25, 2019 (Actual)
Last update posted
Nov 4, 2021

2017 – 2019

United States locations

U.S. sites
70
U.S. states
29
U.S. cities
62
Facility City State ZIP Site status
Central Alabama Research Birmingham Alabama 35209 —
Southern Arizona VA Health Care System Tucson Arizona 85723 —
Medvin Clinical Research Covina California 91722 —
Northern California Research Sacramento California 95821 —
Capital Nephrology Medical Group Sacramento California 95825 —
Inland Rheumatology Clinical Trials, Inc Upland California 91786 —
Medvin Clinical Research - Whittier Whittier California 90602 —
Western Nephrology-Westminster Westminster Colorado 80031 —
New England Research Associates, Llc Trumbull Connecticut 06611 —
Arthritis, Autoimmune, & Allergy LLC Daytona Beach Florida 32117 —
Riverside Clinical Research Edgewater Florida 32132 —
Florida Medical Research Institute Gainesville Florida 32607 —
Eastern Research Hialeah Florida 33013 —
San Marcus Research Clinic Inc Miami Florida 33015 —
LCC Medical Research Institute, LLC Miami Florida 33126 —
Savin Medical Group Miami Lakes Florida 33014 —
Rheumatology Associates of Central Florida Orlando Florida 32806 —
Omega Research Consultants, LLC Orlando Florida 32810 —
BayCare Medical Group, Inc. Tampa Florida 33614 —
Meridien Research - Tampa Tampa Florida 33634 —
The Kaufmann Clinic, Inc Atlanta Georgia 30308 —
Ellipsis Group Atlanta Georgia 30342 —
Rocky Mountain Diabetes and Osteoporosis Center PA Idaho Falls Idaho 83404 —
Clinical Investigation Specialists, Inc. - Gurnee Gurnee Illinois 60031 —
Nephrology Specialists Merrillville Indiana 46410 —
Kansas Nephrology Research Institute Wichita Kansas 67214 —
Center for Arthritis & Osteoporosis Elizabethtown Kentucky 42701 —
Four Rivers Clinical Research Paducah Kentucky 42003 —
Ochsner Clinic Foundation Baton Rouge Louisiana 70809 —
Clinical Trials Management, LLC - Northshore Covington Louisiana 70433 —
Clinical Trials Management LLC - Southshore Metairie Louisiana 70006 —
Arthritis and Diabetes Clinic Monroe Louisiana 71203 —
Northwest Louisiana Nephrology Shreveport Louisiana 71101 —
University of Massachusetts Memorial Medical Center Worcester Massachusetts 01605 —
University of Michigan Ann Arbor Michigan 48109 —
Michigan Kidney Consultants Pontiac Michigan 48341 —
St. Clair Nephrology Research Roseville Michigan 48066 —
CRC of Jackson, LLC Jackson Mississippi 39202 —
VA Medical Center - Kansas City Kansas City Missouri 64128 —
Meridian Clinical Research - Norfolk, NE Norfolk Nebraska 68701 —
New Mexico Clinical Research & Osteoporosis Center Inc. Albuquerque New Mexico 87106 —
Ellipsis Research Group, LLC Brooklyn New York 11215 —
Buffalo VA Medical Center Buffalo New York 14215 —
Winthrop University Hospital Mineola New York 11501 —
DJL Clinical Research PLLC Charlotte North Carolina 28210 —
PhysiqueMed Clinical Trials Greensboro North Carolina 27405 —
Burke Primary Care Morganton North Carolina 28655 —
Trial Management Associates, LLC Wilmington North Carolina 28403 —
Sterling Research Group, Ltd. - Auburn Cincinnati Ohio 45219 —
Sterling Research Group, Ltd. - Cincinnati Cincinnati Ohio 45246 —
Prestige Clinical Research Franklin Ohio 45005 —
Columbia Research Group, Inc. Portland Oregon 97239 —
Northeast Clinical Research Center Bethlehem Pennsylvania 18017 —
Altoona Center for Clinical Research Duncansville Pennsylvania 16635 —
University of Pennsylvania Philadelphia Pennsylvania 19104 —
Rhode Island Hospital East Providence Rhode Island 02914 —
Low Country Rheumatology Charleston South Carolina 29406 —
Piedmont Research Partners, LLC Fort Mill South Carolina 29707 —
Mountain View Clinical Research - Greer Greer South Carolina 29651 —
Knoxville Kidney Center, PLLC Knoxville Tennessee 37923 —
Discovery Alliance International Inc. d/b/a Tennessee Health Research Alliance LLC Nashville Tennessee 37203 —
Nephrology Associates, P.C. Nashville Tennessee 37205 —
FMC Science Lampasas Texas 76550 —
P&I Clinical Research Lufkin Texas 75904 —
Clinical Advancement Center, PLLC San Antonio Texas 78215 —
Briggs Clinical Research, Inc. San Antonio Texas 78224 —
3rd Coast Research Associates Victoria Texas 77901 —
Spectrum Medical, Inc. Danville Virginia 24541 —
Manassas Clinical Research Center Manassas Virginia 20110 —
Clinical Research Partners, LLC Richmond Virginia 23235 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 46 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03226899, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Nov 4, 2021 · Synced Oct 22, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03226899 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →