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

PHASE4TerminatedINTERVENTIONAL
Enrollment

242

Participants

Timeline

Start Date

July 19, 2017

Primary Completion Date

February 25, 2019

Study Completion Date

February 25, 2019

Conditions
GoutChronic Kidney Disease (CKD)
Interventions
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

Trial Locations (116)

1033

Clinexpert Kft., Budapest

2500

Vaszary Kolos Korhaz Esztergom - Reumatologiai osztaly, Esztergom

2921

Selye Janos Hospital - Rheumatology Department, Komárom

3000

BKS Research Kft., Hatvan

3529

CRU Hungary Kft., Miskolc

5000

Allergo-Derm Bakos Kft., Szolnok

5600

Dr Lakatos Ferenc Belgyogyaszati-Kardiologiai Maganrendelo, Békéscsaba

6300

Kalocsai Szent Kereszt Korhaz, Kalocsa

6500

Bajai Szent Rokus Korhaz, Baja

7100

Clinfan Ltd SMO, Szekszárd

8000

Mentahaz Maganorvosi Kozpont (SMO), Székesfehérvár

8200

Medical Expert Kft., Veszprém

8230

DRC Gyogyszervizsgalo Kozpont Kft, Balatonfüred

11215

Ellipsis Research Group, LLC, Brooklyn

11501

Winthrop University Hospital, Mineola

14215

Buffalo VA Medical Center, Buffalo

16635

Altoona Center for Clinical Research, Duncansville

18017

Northeast Clinical Research Center, Bethlehem

19104

University of Pennsylvania, Philadelphia

20110

Manassas Clinical Research Center, Manassas

23235

Clinical Research Partners, LLC, Richmond

24541

Spectrum Medical, Inc., Danville

27405

PhysiqueMed Clinical Trials, Greensboro

28210

DJL Clinical Research PLLC, Charlotte

28403

Trial Management Associates, LLC, Wilmington

28655

Burke Primary Care, Morganton

29406

Low Country Rheumatology, Charleston

29651

Mountain View Clinical Research - Greer, Greer

29707

Piedmont Research Partners, LLC, Fort Mill

30308

The Kaufmann Clinic, Inc, Atlanta

30342

Ellipsis Group, Atlanta

32117

Arthritis, Autoimmune, & Allergy LLC, Daytona Beach

32132

Riverside Clinical Research, Edgewater

32607

Florida Medical Research Institute, Gainesville

32806

Rheumatology Associates of Central Florida, Orlando

32810

Omega Research Consultants, LLC, Orlando

33013

Eastern Research, Hialeah

33014

Savin Medical Group, Miami Lakes

33015

San Marcus Research Clinic Inc, Miami

33126

LCC Medical Research Institute, LLC, Miami

33614

BayCare Medical Group, Inc., Tampa

33634

Meridien Research - Tampa, Tampa

35209

Central Alabama Research, Birmingham

37203

Discovery Alliance International Inc. d/b/a Tennessee Health Research Alliance LLC, Nashville

37205

Nephrology Associates, P.C., Nashville

37923

Knoxville Kidney Center, PLLC, Knoxville

39202

CRC of Jackson, LLC, Jackson

40113

Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o.z., Ústí nad Labem

42003

Four Rivers Clinical Research, Paducah

42701

Center for Arthritis & Osteoporosis, Elizabethtown

45005

Prestige Clinical Research, Franklin

45219

Sterling Research Group, Ltd. - Auburn, Cincinnati

45246

Sterling Research Group, Ltd. - Cincinnati, Cincinnati

46410

Nephrology Specialists, Merrillville

48066

St. Clair Nephrology Research, Roseville

48109

University of Michigan, Ann Arbor

48341

Michigan Kidney Consultants, Pontiac

53002

CCBR Clinical Research, Pardubice, Pardubice

60031

Clinical Investigation Specialists, Inc. - Gurnee, Gurnee

60200

CCBR Czech Brno, s. r. o, Brno

62500

DTTO Faculty Hospital Brno, Brno

64128

VA Medical Center - Kansas City, Kansas City

66902

Nemocnice Znojmo p.o - Interni oddeleni, Znojmo

67214

Kansas Nephrology Research Institute, Wichita

68701

Meridian Clinical Research - Norfolk, NE, Norfolk

70006

Clinical Trials Management LLC - Southshore, Metairie

70200

CCBR Ostrava s.r.o., Ostrava

70433

Clinical Trials Management, LLC - Northshore, Covington

70809

Ochsner Clinic Foundation, Baton Rouge

71101

Northwest Louisiana Nephrology, Shreveport

71203

Arthritis and Diabetes Clinic, Monroe

75904

P&I Clinical Research, Lufkin

76550

FMC Science, Lampasas

77901

3rd Coast Research Associates, Victoria

78215

Clinical Advancement Center, PLLC, San Antonio

78224

Briggs Clinical Research, Inc., San Antonio

80031

Western Nephrology-Westminster, Westminster

83404

Rocky Mountain Diabetes and Osteoporosis Center PA, Idaho Falls

85723

Southern Arizona VA Health Care System, Tucson

87106

New Mexico Clinical Research & Osteoporosis Center Inc., Albuquerque

90602

Medvin Clinical Research - Whittier, Whittier

91722

Medvin Clinical Research, Covina

91786

Inland Rheumatology Clinical Trials, Inc, Upland

95821

Northern California Research, Sacramento

95825

Capital Nephrology Medical Group, Sacramento

97239

Columbia Research Group, Inc., Portland

06611

New England Research Associates, Llc, Trumbull

01605

University of Massachusetts Memorial Medical Center, Worcester

02914

Rhode Island Hospital, East Providence

611 41

REVMACLINIC s.r.o. - Revmatologicka ambulance, Brno

779 00

Revmatologie MUDr. Bilkova s.r.o., Olomouc

130 00

CCBR Czech Prague s.r.o., Prague

686 01

MEDICAL PLUS, s.r.o. - Revmatologicka ambulance, Uherské Hradiště

760 01

PV - MEDICAL, s.r.o., Zlín

96-300

Stacja Dializ Zyrardow, Żyrardów

Centrum Dializa Sp. z o.o. - Zyrardow, Żyrardów

41-500

B_Serwis Popenda Sp. J., Chorzów

82-300

Centrum Kliniczno Badawcze J. Brzezicki B. Gornikiewicz - Brzezicka Lekarze Sp. p., Elblag

05-825

MCBK s.c., Grodzisk Mazowiecki

40-040

NZOZ Praktyka Lekarza Rodzinnego Elzbieta Kelm, Katowice

30-002

Centrum Medyczne Pratia Krakow, Krakow

30-510

Malopolskie Centrum Medyczne, Krakow

90-153

Samodzielny Publiczny ZOZ Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi, Oddzial Kliniczny Nefrologii, Hipertensjologii i Transplantologii Nerek, Lodz

90-242

Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo Akcyjna, Lodz

90-349

AppleTreeClinics Sp. z o.o., Lodz

91-363

Centrum Medyczne AMED Oddzial w Lodzi, Lodz

94-048

NZOZ All - Med Centrum Medyczne Specjalistyczne Gabinety Lekarskie Marcin Ogorek, Lodz

20-093

Centrum Medyczne Chodzki, Lublin

33-300

Alfa Specjalistyczne Gabinety Lekarskie Ewa Moroz, Nowy Sącz

60-589

Centrum Zdrowia Metabolicznego Pawel Bogdanski, Poznan

60-773

Centrum Badan Klinicznych s.c., Poznan

61-655

Praktyka Lekarska Ewa Krzyzagorska, Poznan

26-610

Prywatny Gabinet Lekarski NZOZ Centrum Medyczne Aeskulap, Radom

01-868

Centrum Medyczne Pratia Warszawa, Warsaw

05-200

Centrum Medyczne K2J2, Wołomin

22-400

KO - MED Centra Kliniczne Sp. z o.o., Osrodek Badan Klinicznych w Zamosciu, Zamość

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Medpace, Inc.

INDUSTRY

lead

Ironwood Pharmaceuticals, Inc.

INDUSTRY