Last updated on March 2019

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


Brief description of study

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 sUA.

Detailed Study 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 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.

Clinical Study Identifier: NCT03226899

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Central Alabama Research

Birmingham, AL United States

Southern Arizona VA Health Care System

Tucson, AZ United States

Medvin Clinical Research

Covina, CA United States

Northern California Research

Sacramento, CA United States

Capital Nephrology Medical Group

Sacramento, CA United States

Inland Rheumatology Clinical Trials, Inc

Upland, CA United States

Medvin Clinical Research - Whittier

Whittier, CA United States

Western Nephrology-Westminster

Westminster, CO United States

New England Research Associates, Llc

Trumbull, CT United States

Arthritis, Autoimmune, & Allergy LLC

Daytona Beach, FL United States

Riverside Clinical Research

Edgewater, FL United States

Florida Medical Research Institute

Gainesville, FL United States

Eastern Research

Hialeah, FL United States

Savin Medical Group

Miami Lakes, FL United States

San Marcus Research Clinic Inc

Miami, FL United States

LCC Medical Research Institute, LLC

Miami, FL United States

Rheumatology Associates of Central Florida

Orlando, FL United States

Omega Research Consultants, LLC

Orlando, FL United States

BayCare Medical Group, Inc.

Tampa, FL United States

Meridien Research - Tampa

Tampa, FL United States

The Kaufmann Clinic, Inc

Atlanta, GA United States

Ellipsis Group

Atlanta, GA United States

Nephrology Specialists

Merrillville, IN United States

Kansas Nephrology Research Institute

Wichita, KS United States

Center for Arthritis & Osteoporosis

Elizabethtown, KY United States

Four Rivers Clinical Research

Paducah, KY United States

Ochsner Clinic Foundation

Baton Rouge, LA United States

Clinical Trials Management, LLC - Northshore

Covington, LA United States

Clinical Trials Management LLC - Southshore

Metairie, LA United States

Arthritis and Diabetes Clinic

Monroe, LA United States

Northwest Louisiana Nephrology

Shreveport, LA United States

University of Michigan

Ann Arbor, MI United States

Michigan Kidney Consultants

Pontiac, MI United States

St. Clair Nephrology Research

Roseville, MI United States

CRC of Jackson, LLC

Jackson, MS United States

VA Medical Center - Kansas City

Kansas City, MO United States

Meridian Clinical Research - Norfolk, NE

Norfolk, NE United States

Ellipsis Research Group, LLC

Brooklyn, NY United States

Buffalo VA Medical Center

Buffalo, NY United States

Winthrop University Hospital

Mineola, NY United States

DJL Clinical Research PLLC

Charlotte, NC United States

PhysiqueMed Clinical Trials

Greensboro, NC United States

Burke Primary Care

Morganton, NC United States

Trial Management Associates, LLC

Wilmington, NC United States

Sterling Research Group, Ltd. - Auburn

Cincinnati, OH United States

Sterling Research Group, Ltd. - Cincinnati

Cincinnati, OH United States

Prestige Clinical Research

Franklin, OH United States

Columbia Research Group, Inc.

Portland, OR United States

Northeast Clinical Research Center

Bethlehem, PA United States

Altoona Center for Clinical Research

Duncansville, PA United States

University of Pennsylvania

Philadelphia, PA United States

Rhode Island Hospital

East Providence, RI United States

Low Country Rheumatology

Charleston, SC United States

Piedmont Research Partners, LLC

Fort Mill, SC United States

Mountain View Clinical Research - Greer

Greer, SC United States

Knoxville Kidney Center, PLLC

Knoxville, TN United States

Nephrology Associates, P.C.

Nashville, TN United States

FMC Science

Lampasas, TX United States

P&I Clinical Research

Lufkin, TX United States

Clinical Advancement Center, PLLC

San Antonio, TX United States

Briggs Clinical Research, Inc.

San Antonio, TX United States

3rd Coast Research Associates

Victoria, TX United States

Spectrum Medical, Inc.

Danville, VA United States

Manassas Clinical Research Center

Manassas, VA United States

Clinical Research Partners, LLC

Richmond, VA United States

CCBR Czech Brno, s. r. o

Brno, Czechia

CCBR Ostrava s.r.o.

Ostrava, Czechia

CCBR Czech Prague s.r.o.

Prague, Czechia

Bajai Szent Rokus Korhaz

Baja, Hungary

Clinexpert Kft.

Budapest, Hungary

BKS Research Kft.

Hatvan, Hungary

CRU Hungary Kft.

Miskolc, Hungary

Allergo-Derm Bakos Kft.

Szolnok, Hungary

Medical Expert Kft.

Veszprem, Hungary

Stacja Dializ Zyrardow

Zyrardow, Poland

PV - MEDICAL, s.r.o.

Zlín, Czechia

DRC Gyogyszervizsgalo Kozpont Kft

Balatonfüred, Hungary

Clinfan Ltd SMO

Szekszárd, Hungary

Mentahaz Maganorvosi Kozpont (SMO)

Székesfehérvár, Hungary

B_Serwis Popenda Sp. J.

Chorzów, Poland

Recruitment Status: Closed


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