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.
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 18 Years - 85 Years |
Gender | All |
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT03226899 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 4 |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Ironwood Pharmaceuticals, Inc. |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Niels Borgstein, MD |
Principal Investigator Affiliation | Ironwood Pharmaceuticals, Inc. |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
Overall Status | Recruiting |
Countries | Czechia, Hungary, Poland, United States |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Gout, Chronic Kidney Disease (CKD) |
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.
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Recruiting
Address
Central Alabama Research
Birmingham, Alabama, 35209
Status
Recruiting
Address
Southern Arizona VA Health Care System
Tucson, Arizona, 85723
Status
Recruiting
Address
Medvin Clinical Research
Covina, California, 91722
Status
Recruiting
Address
Northern California Research
Sacramento, California, 95821
Status
Recruiting
Address
Capital Nephrology Medical Group
Sacramento, California, 95825
Status
Recruiting
Address
Inland Rheumatology Clinical Trials, Inc
Upland, California, 91786
Status
Recruiting
Address
Medvin Clinical Research - Whittier
Whittier, California, 90602
Status
Recruiting
Address
Western Nephrology-Westminster
Westminster, Colorado, 80031
Status
Recruiting
Address
New England Research Associates, Llc
Trumbull, Connecticut, 06611
Status
Recruiting
Address
Arthritis, Autoimmune, & Allergy LLC
Daytona Beach, Florida, 32117
Status
Recruiting
Address
Riverside Clinical Research
Edgewater, Florida, 32132
Status
Recruiting
Address
Florida Medical Research Institute
Gainesville, Florida, 32607
Status
Recruiting
Address
Eastern Research
Hialeah, Florida, 33013
Status
Recruiting
Address
Savin Medical Group
Miami Lakes, Florida, 33014
Status
Recruiting
Address
San Marcus Research Clinic Inc
Miami, Florida, 33015
Status
Recruiting
Address
LCC Medical Research Institute, LLC
Miami, Florida, 33126
Status
Recruiting
Address
Rheumatology Associates of Central Florida
Orlando, Florida, 32806
Status
Recruiting
Address
Omega Research Consultants, LLC
Orlando, Florida, 32810
Status
Recruiting
Address
BayCare Medical Group, Inc.
Tampa, Florida, 33614
Status
Recruiting
Address
Meridien Research - Tampa
Tampa, Florida, 33634
Status
Recruiting
Address
The Kaufmann Clinic, Inc
Atlanta, Georgia, 30308
Status
Recruiting
Address
Ellipsis Group
Atlanta, Georgia, 30342
Status
Recruiting
Address
Rocky Mountain Diabetes and Osteoporosis Center PA
Idaho Falls, Idaho, 83404
Status
Recruiting
Address
Clinical Investigation Specialists, Inc. - Gurnee
Gurnee, Illinois, 60031
Status
Recruiting
Address
Nephrology Specialists
Merrillville, Indiana, 46410
Status
Recruiting
Address
Kansas Nephrology Research Institute
Wichita, Kansas, 67214
Status
Recruiting
Address
Center for Arthritis & Osteoporosis
Elizabethtown, Kentucky, 42701
Status
Recruiting
Address
Four Rivers Clinical Research
Paducah, Kentucky, 42003
Status
Recruiting
Address
Ochsner Clinic Foundation
Baton Rouge, Louisiana, 70809
Status
Recruiting
Address
Clinical Trials Management, LLC - Northshore
Covington, Louisiana, 70433
Status
Recruiting
Address
Clinical Trials Management LLC - Southshore
Metairie, Louisiana, 70006
Status
Recruiting
Address
Arthritis and Diabetes Clinic
Monroe, Louisiana, 71203
Status
Recruiting
Address
Northwest Louisiana Nephrology
Shreveport, Louisiana, 71101
Status
Not yet recruiting
Address
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01605
Status
Recruiting
Address
University of Michigan
Ann Arbor, Michigan, 48109
Status
Recruiting
Address
Michigan Kidney Consultants
Pontiac, Michigan, 48341
Status
Recruiting
Address
St. Clair Nephrology Research
Roseville, Michigan, 48066
Status
Recruiting
Address
CRC of Jackson, LLC
Jackson, Mississippi, 39202
Status
Recruiting
Address
VA Medical Center - Kansas City
Kansas City, Missouri, 64128
Status
Recruiting
Address
Meridian Clinical Research - Norfolk, NE
Norfolk, Nebraska, 68701
Status
Recruiting
Address
New Mexico Clinical Research & Osteoporosis Center Inc.
Albuquerque, New Mexico, 87106
Status
Recruiting
Address
Ellipsis Research Group, LLC
Brooklyn, New York, 11215
Status
Recruiting
Address
Buffalo VA Medical Center
Buffalo, New York, 14215
Status
Recruiting
Address
Winthrop University Hospital
Mineola, New York, 11501
Status
Recruiting
Address
DJL Clinical Research PLLC
Charlotte, North Carolina, 28210
Status
Recruiting
Address
PhysiqueMed Clinical Trials
Greensboro, North Carolina, 27405
Status
Recruiting
Address
Burke Primary Care
Morganton, North Carolina, 28655
Status
Recruiting
Address
Trial Management Associates, LLC
Wilmington, North Carolina, 28403
Status
Recruiting
Address
Sterling Research Group, Ltd. - Auburn
Cincinnati, Ohio, 45219
Status
Recruiting
Address
Sterling Research Group, Ltd. - Cincinnati
Cincinnati, Ohio, 45246
Status
Recruiting
Address
Prestige Clinical Research
Franklin, Ohio, 45005
Status
Recruiting
Address
Columbia Research Group, Inc.
Portland, Oregon, 97239
Status
Recruiting
Address
Northeast Clinical Research Center
Bethlehem, Pennsylvania, 18017
Status
Recruiting
Address
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
Status
Not yet recruiting
Address
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Status
Recruiting
Address
Rhode Island Hospital
East Providence, Rhode Island, 02914
Status
Recruiting
Address
Low Country Rheumatology
Charleston, South Carolina, 29406
Status
Recruiting
Address
Piedmont Research Partners, LLC
Fort Mill, South Carolina, 29707
Status
Recruiting
Address
Mountain View Clinical Research - Greer
Greer, South Carolina, 29651
Status
Recruiting
Address
Knoxville Kidney Center, PLLC
Knoxville, Tennessee, 37923
Status
Recruiting
Address
Discovery Alliance International Inc. d/b/a Tennessee Health Research Alliance LLC
Nashville, Tennessee, 37203
Status
Recruiting
Address
Nephrology Associates, P.C.
Nashville, Tennessee, 37205
Status
Recruiting
Address
FMC Science
Lampasas, Texas, 76550
Status
Recruiting
Address
P&I Clinical Research
Lufkin, Texas, 75904
Status
Recruiting
Address
Clinical Advancement Center, PLLC
San Antonio, Texas, 78215
Status
Recruiting
Address
Briggs Clinical Research, Inc.
San Antonio, Texas, 78224
Status
Recruiting
Address
3rd Coast Research Associates
Victoria, Texas, 77901
Status
Recruiting
Address
Spectrum Medical, Inc.
Danville, Virginia, 24541
Status
Recruiting
Address
Manassas Clinical Research Center
Manassas, Virginia, 20110
Status
Recruiting
Address
Clinical Research Partners, LLC
Richmond, Virginia, 23235
Status
Recruiting
Address
CCBR Czech Brno, s. r. o
Brno, , 60200
Status
Recruiting
Address
REVMACLINIC s.r.o. - Revmatologicka ambulance
Brno, , 611 41
Status
Recruiting
Address
DTTO Faculty Hospital Brno
Brno, , 62500
Status
Recruiting
Address
Revmatologie MUDr. Bilkova s.r.o.
Olomouc, , 779 00
Status
Recruiting
Address
CCBR Ostrava s.r.o.
Ostrava, , 70200
Status
Recruiting
Address
CCBR Clinical Research, Pardubice
Pardubice, , 53002
Status
Recruiting
Address
CCBR Czech Prague s.r.o.
Prague, , 130 00
Status
Recruiting
Address
MEDICAL PLUS, s.r.o. - Revmatologicka ambulance
Uherske Hradiste, , 686 01
Status
Recruiting
Address
Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o.z.
Usti nad Labem, , 40113
Status
Recruiting
Address
PV - MEDICAL, s.r.o.
Zlín, , 760 01
Status
Recruiting
Address
Nemocnice Znojmo p.o - Interni oddeleni
Znojmo, , 66902
Status
Recruiting
Address
Bajai Szent Rokus Korhaz
Baja, , 6500
Status
Recruiting
Address
DRC Gyogyszervizsgalo Kozpont Kft
Balatonfüred, , 8230
Status
Recruiting
Address
Clinexpert Kft.
Budapest, , 1033
Status
Recruiting
Address
Dr Lakatos Ferenc Belgyogyaszati-Kardiologiai Maganrendelo
Békéscsaba, , 5600
Status
Recruiting
Address
Vaszary Kolos Korhaz Esztergom - Reumatologiai osztaly
Esztergom, , 2500
Status
Recruiting
Address
BKS Research Kft.
Hatvan, , 3000
Status
Recruiting
Address
Kalocsai Szent Kereszt Korhaz
Kalocsa, , 6300
Status
Recruiting
Address
Selye Janos Hospital - Rheumatology Department
Komárom, , 2921
Status
Recruiting
Address
CRU Hungary Kft.
Miskolc, , 3529
Status
Recruiting
Address
Clinfan Ltd SMO
Szekszárd, , 7100
Status
Recruiting
Address
Allergo-Derm Bakos Kft.
Szolnok, , 5000
Status
Recruiting
Address
Mentahaz Maganorvosi Kozpont (SMO)
Székesfehérvár, , 8000
Status
Recruiting
Address
Medical Expert Kft.
Veszprem, , 8200
Status
Recruiting
Address
Stacja Dializ Zyrardow
Zyrardow, Zyrardo, 96-300
Status
Recruiting
Address
B_Serwis Popenda Sp. J.
Chorzów, , 41-500
Status
Recruiting
Address
Centrum Kliniczno Badawcze J. Brzezicki B. Gornikiewicz - Brzezicka Lekarze Sp. p.
Elbląg, , 82-300
Status
Recruiting
Address
MCBK s.c.
Grodzisk Mazowiecki, , 05-825
Status
Recruiting
Address
NZOZ Praktyka Lekarza Rodzinnego Elzbieta Kelm
Katowice, , 40-040
Status
Recruiting
Address
Centrum Medyczne Pratia Krakow
Kraków, , 30-002
Status
Recruiting
Address
Malopolskie Centrum Medyczne
Kraków, , 30-510
Status
Recruiting
Address
Centrum Medyczne Chodzki
Lublin, , 20-093
Status
Recruiting
Address
Alfa Specjalistyczne Gabinety Lekarskie Ewa Moroz
Nowy Sącz, , 33-300
Status
Recruiting
Address
Centrum Zdrowia Metabolicznego Pawel Bogdanski
Poznań, , 60-589
Status
Not yet recruiting
Address
Centrum Badan Klinicznych s.c.
Poznań, , 60-773
Status
Recruiting
Address
Praktyka Lekarska Ewa Krzyzagorska
Poznań, , 61-655
Status
Recruiting
Address
Prywatny Gabinet Lekarski NZOZ Centrum Medyczne Aeskulap
Radom, , 26-610
Status
Recruiting
Address
Centrum Medyczne Pratia Warszawa
Warszawa, , 01-868
Status
Recruiting
Address
Centrum Medyczne K2J2
Wołomin, , 05-200
Status
Recruiting
Address
KO - MED Centra Kliniczne Sp. z o.o., Osrodek Badan Klinicznych w Zamosciu
Zamość, , 22-400
Status
Recruiting
Address
Samodzielny Publiczny ZOZ Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi, Oddzial Kliniczny Nefrologii, Hipertensjologii i Transplantologii Nerek
Łódź, , 90-153
Status
Recruiting
Address
Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo Akcyjna
Łódź, , 90-242
Status
Recruiting
Address
AppleTreeClinics Sp. z o.o.
Łódź, , 90-349
Status
Recruiting
Address
Centrum Medyczne AMED Oddzial w Lodzi
Łódź, , 91-363
Status
Recruiting
Address
NZOZ All - Med Centrum Medyczne Specjalistyczne Gabinety Lekarskie Marcin Ogorek
Łódź, , 94-048
Status
Recruiting
Address
Centrum Dializa Sp. z o.o. - Zyrardow
Żyrardów, , 96-300