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Clinical Trial Details

Trial ID: L0793
Source ID: NCT03226899
Associated Drug: Lesinurad
Title: A Phase 4 Safety and Efficacy Study to Evaluate Lesinurad 200 mg in Participants With Gout and Renal Impairment
Acronym:
Status: TERMINATED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT03226899/results
Conditions: Gout|Chronic Kidney Disease (CKD)
Interventions: DRUG: Lesinurad|DRUG: XOI|DRUG: Placebo|DRUG: colchicine|DRUG: corticosteroids
Outcome Measures: Primary: Percentage of Participants Who Achieve Serum Urate (sUA) < 6.0 mg/dL at Month 6, Month 6 | Secondary: Percentage of Participants Who Achieve sUA < 6.0 mg/dL Over Time, Baseline, Months 1, 3, 6, 9, 12, 15, 18|Change From Baseline in sUA Over Time, Including the Last Value On and Off Treatment, Baseline, Months 1, 3, 6, 9, 12, 15, 18|Percent Change From Baseline in sUA Over Time, Including the Last Value On and Off Treatment, Baseline, Months 1, 3, 6, 9, 12, 15, 18|Change From Baseline in Estimated Creatinine Clearance (eCrCl) at Month 24, The eCrCl was calculated by the Cockcroft-Gault formula using ideal body weight., Baseline, 24 months|Percent Change From Baseline in eCrCl at Month 24, The eCrCl was calculated by the Cockcroft-Gault formula using ideal body weight., Baseline, 24 months|Change From Baseline in eCrCl Over the Study Period, Including the Last Value On and Off Treatment, The eCrCl was calculated by the Cockcroft-Gault formula using ideal body weight., Baseline, Months 1, 3, 6, 9, 12, 15, 18|Percent Change From Baseline in eCrCl Over the Study Period, Including the Last Value On and Off Treatment, The eCrCl was calculated by the Cockcroft-Gault formula using ideal body weight., Baseline, Months 1, 3, 6, 9, 12, 15, 18|Percentage of Participants With Serum Creatinine (sCr) Elevations (≥1.5 × Baseline) Over the Study Period, up to 18 months|Percentage of Participants Meeting Criteria (eg, Based on sCr or eCrCl Criteria) for Treatment Discontinuations Over the Study Period, Kidney function was monitored throughout the study by measuring sCr and calculating eCrCl by Cockcroft-Gault formula using ideal body weight. Treatment discontinuations were required if a participant experienced an absolute sCr ≥4.0 mg/dL or an eCrCl \<20 mL/min (based on central laboratory results)., up to 18 months|Percentage of Participants Renal-Related and Kidney Stone Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs), Renal-related and kidney stone events were based on Medical Dictionary for Regulatory Activities (MedDRA) "Renal and Urinary Disorders" system organ classification. AEs that started on or after the first dose of study drug in this study, or those AEs with onset prior to the first dose of study drug but worsened after the first dose of study drug, were considered treatment emergent., From first dose of study drug through each participant's study duration, up to approximately 18 months.|Percentage of Participants With Contributing Factors to Renal SAEs as Adjudicated by the Renal Event Adjudication Committee (REAC), From first dose of study drug through each participant's study duration, up to approximately 18 months.|Percentage of Participants With Cardiac Event Adjudication Committee (CEAC)-Adjudicated Major Adverse Cardiovascular Events (MACEs), MACEs are defined as Cardiovascular Death, Nonfatal Myocardial Infarction, and Nonfatal Stroke., From first dose of study drug through each participant's study duration, up to approximately 18 months.|Incidence of CEAC-Adjudicated MACEs or Hospitalization for Unstable Angina (MACE+), MACEs are defined as Cardiovascular Death, Nonfatal Myocardial Infarction, and Nonfatal Stroke., From first dose of study drug through each participant's study duration, up to approximately 18 months.
Sponsor/Collaborators: Sponsor: Ironwood Pharmaceuticals, Inc. | Collaborators: Medpace, Inc.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 242
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2017-07-19
Completion Date: 2019-02-25
Results First Posted: 2021-11-04
Last Update Posted: 2021-11-04
Locations: Central Alabama Research, Birmingham, Alabama, 35209, United States|Southern Arizona VA Health Care System, Tucson, Arizona, 85723, United States|Medvin Clinical Research, Covina, California, 91722, United States|Northern California Research, Sacramento, California, 95821, United States|Capital Nephrology Medical Group, Sacramento, California, 95825, United States|Inland Rheumatology Clinical Trials, Inc, Upland, California, 91786, United States|Medvin Clinical Research - Whittier, Whittier, California, 90602, United States|Western Nephrology-Westminster, Westminster, Colorado, 80031, United States|New England Research Associates, Llc, Trumbull, Connecticut, 06611, United States|Arthritis, Autoimmune, & Allergy LLC, Daytona Beach, Florida, 32117, United States|Riverside Clinical Research, Edgewater, Florida, 32132, United States|Florida Medical Research Institute, Gainesville, Florida, 32607, United States|Eastern Research, Hialeah, Florida, 33013, United States|Savin Medical Group, Miami Lakes, Florida, 33014, United States|San Marcus Research Clinic Inc, Miami, Florida, 33015, United States|LCC Medical Research Institute, LLC, Miami, Florida, 33126, United States|Rheumatology Associates of Central Florida, Orlando, Florida, 32806, United States|Omega Research Consultants, LLC, Orlando, Florida, 32810, United States|BayCare Medical Group, Inc., Tampa, Florida, 33614, United States|Meridien Research - Tampa, Tampa, Florida, 33634, United States|The Kaufmann Clinic, Inc, Atlanta, Georgia, 30308, United States|Ellipsis Group, Atlanta, Georgia, 30342, United States|Rocky Mountain Diabetes and Osteoporosis Center PA, Idaho Falls, Idaho, 83404, United States|Clinical Investigation Specialists, Inc. - Gurnee, Gurnee, Illinois, 60031, United States|Nephrology Specialists, Merrillville, Indiana, 46410, United States|Kansas Nephrology Research Institute, Wichita, Kansas, 67214, United States|Center for Arthritis & Osteoporosis, Elizabethtown, Kentucky, 42701, United States|Four Rivers Clinical Research, Paducah, Kentucky, 42003, United States|Ochsner Clinic Foundation, Baton Rouge, Louisiana, 70809, United States|Clinical Trials Management, LLC - Northshore, Covington, Louisiana, 70433, United States|Clinical Trials Management LLC - Southshore, Metairie, Louisiana, 70006, United States|Arthritis and Diabetes Clinic, Monroe, Louisiana, 71203, United States|Northwest Louisiana Nephrology, Shreveport, Louisiana, 71101, United States|University of Massachusetts Memorial Medical Center, Worcester, Massachusetts, 01605, United States|University of Michigan, Ann Arbor, Michigan, 48109, United States|Michigan Kidney Consultants, Pontiac, Michigan, 48341, United States|St. Clair Nephrology Research, Roseville, Michigan, 48066, United States|CRC of Jackson, LLC, Jackson, Mississippi, 39202, United States|VA Medical Center - Kansas City, Kansas City, Missouri, 64128, United States|Meridian Clinical Research - Norfolk, NE, Norfolk, Nebraska, 68701, United States|New Mexico Clinical Research & Osteoporosis Center Inc., Albuquerque, New Mexico, 87106, United States|Ellipsis Research Group, LLC, Brooklyn, New York, 11215, United States|Buffalo VA Medical Center, Buffalo, New York, 14215, United States|Winthrop University Hospital, Mineola, New York, 11501, United States|DJL Clinical Research PLLC, Charlotte, North Carolina, 28210, United States|PhysiqueMed Clinical Trials, Greensboro, North Carolina, 27405, United States|Burke Primary Care, Morganton, North Carolina, 28655, United States|Trial Management Associates, LLC, Wilmington, North Carolina, 28403, United States|Sterling Research Group, Ltd. - Auburn, Cincinnati, Ohio, 45219, United States|Sterling Research Group, Ltd. - Cincinnati, Cincinnati, Ohio, 45246, United States|Prestige Clinical Research, Franklin, Ohio, 45005, United States|Columbia Research Group, Inc., Portland, Oregon, 97239, United States|Northeast Clinical Research Center, Bethlehem, Pennsylvania, 18017, United States|Altoona Center for Clinical Research, Duncansville, Pennsylvania, 16635, United States|University of Pennsylvania, Philadelphia, Pennsylvania, 19104, United States|Rhode Island Hospital, East Providence, Rhode Island, 02914, United States|Low Country Rheumatology, Charleston, South Carolina, 29406, United States|Piedmont Research Partners, LLC, Fort Mill, South Carolina, 29707, United States|Mountain View Clinical Research - Greer, Greer, South Carolina, 29651, United States|Knoxville Kidney Center, PLLC, Knoxville, Tennessee, 37923, United States|Discovery Alliance International Inc. d/b/a Tennessee Health Research Alliance LLC, Nashville, Tennessee, 37203, United States|Nephrology Associates, P.C., Nashville, Tennessee, 37205, United States|FMC Science, Lampasas, Texas, 76550, United States|P&I Clinical Research, Lufkin, Texas, 75904, United States|Clinical Advancement Center, PLLC, San Antonio, Texas, 78215, United States|Briggs Clinical Research, Inc., San Antonio, Texas, 78224, United States|3rd Coast Research Associates, Victoria, Texas, 77901, United States|Spectrum Medical, Inc., Danville, Virginia, 24541, United States|Manassas Clinical Research Center, Manassas, Virginia, 20110, United States|Clinical Research Partners, LLC, Richmond, Virginia, 23235, United States|CCBR Czech Brno, s. r. o, Brno, 60200, Czechia|REVMACLINIC s.r.o. - Revmatologicka ambulance, Brno, 611 41, Czechia|DTTO Faculty Hospital Brno, Brno, 62500, Czechia|Revmatologie MUDr. Bilkova s.r.o., Olomouc, 779 00, Czechia|CCBR Ostrava s.r.o., Ostrava, 70200, Czechia|CCBR Clinical Research, Pardubice, Pardubice, 53002, Czechia|CCBR Czech Prague s.r.o., Prague, 130 00, Czechia|MEDICAL PLUS, s.r.o. - Revmatologicka ambulance, Uherske Hradiste, 686 01, Czechia|Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o.z., Usti nad Labem, 40113, Czechia|PV - MEDICAL, s.r.o., Zlín, 760 01, Czechia|Nemocnice Znojmo p.o - Interni oddeleni, Znojmo, 66902, Czechia|Bajai Szent Rokus Korhaz, Baja, 6500, Hungary|DRC Gyogyszervizsgalo Kozpont Kft, Balatonfüred, 8230, Hungary|Clinexpert Kft., Budapest, 1033, Hungary|Dr Lakatos Ferenc Belgyogyaszati-Kardiologiai Maganrendelo, Békéscsaba, 5600, Hungary|Vaszary Kolos Korhaz Esztergom - Reumatologiai osztaly, Esztergom, 2500, Hungary|BKS Research Kft., Hatvan, 3000, Hungary|Kalocsai Szent Kereszt Korhaz, Kalocsa, 6300, Hungary|Selye Janos Hospital - Rheumatology Department, Komárom, 2921, Hungary|CRU Hungary Kft., Miskolc, 3529, Hungary|Clinfan Ltd SMO, Szekszárd, 7100, Hungary|Allergo-Derm Bakos Kft., Szolnok, 5000, Hungary|Mentahaz Maganorvosi Kozpont (SMO), Székesfehérvár, 8000, Hungary|Medical Expert Kft., Veszprem, 8200, Hungary|Stacja Dializ Zyrardow, Zyrardow, Zyrardo, 96-300, Poland|B_Serwis Popenda Sp. J., Chorzów, 41-500, Poland|Centrum Kliniczno Badawcze J. Brzezicki B. Gornikiewicz - Brzezicka Lekarze Sp. p., Elbląg, 82-300, Poland|MCBK s.c., Grodzisk Mazowiecki, 05-825, Poland|NZOZ Praktyka Lekarza Rodzinnego Elzbieta Kelm, Katowice, 40-040, Poland|Centrum Medyczne Pratia Krakow, Kraków, 30-002, Poland|Malopolskie Centrum Medyczne, Kraków, 30-510, Poland|Centrum Medyczne Chodzki, Lublin, 20-093, Poland|Alfa Specjalistyczne Gabinety Lekarskie Ewa Moroz, Nowy Sącz, 33-300, Poland|Centrum Zdrowia Metabolicznego Pawel Bogdanski, Poznań, 60-589, Poland|Centrum Badan Klinicznych s.c., Poznań, 60-773, Poland|Praktyka Lekarska Ewa Krzyzagorska, Poznań, 61-655, Poland|Prywatny Gabinet Lekarski NZOZ Centrum Medyczne Aeskulap, Radom, 26-610, Poland|Centrum Medyczne Pratia Warszawa, Warszawa, 01-868, Poland|Centrum Medyczne K2J2, Wołomin, 05-200, Poland|KO - MED Centra Kliniczne Sp. z o.o., Osrodek Badan Klinicznych w Zamosciu, Zamość, 22-400, Poland|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, Poland|Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo Akcyjna, Łódź, 90-242, Poland|AppleTreeClinics Sp. z o.o., Łódź, 90-349, Poland|Centrum Medyczne AMED Oddzial w Lodzi, Łódź, 91-363, Poland|NZOZ All - Med Centrum Medyczne Specjalistyczne Gabinety Lekarskie Marcin Ogorek, Łódź, 94-048, Poland|Centrum Dializa Sp. z o.o. - Zyrardow, Żyrardów, 96-300, Poland
URL: https://clinicaltrials.gov/show/NCT03226899

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D501 Lesinurad small molecule DB11560 Details