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Clinical Trial Details

Trial ID: L0492
Source ID: NCT02160145
Associated Drug: Tolvaptan (Opc-41061)
Title: Efficacy and Safety of Tolvaptan in Subjects With Chronic Kidney Disease Between Late Stage 2 to Early Stage 4 Due to Autosomal Dominant Polycystic Kidney Disease
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02160145/results
Conditions: Chronic Kidney Disease|Autosomal Dominant Polycystic Kidney Disease
Interventions: DRUG: Tolvaptan (OPC-41061)|DRUG: Placebo
Outcome Measures: Primary: The Mean Annualized Change in eGFR From Pretreatment Baseline to Post-treatment Follow-up., The mean annualized change in eGFR was calculated using the Chronic Kidney Disease-Epidemiology (CKD-EPI) formula from pretreatment baseline to post-treatment follow-up, annualized (divided) by each subject's trial duration. The baseline for the primary endpoint was defined as the average of up to 3 eGFR values observed during the screening and placebo run-in periods., Pretreatment baseline to post-treatment follow-up (up to 61 weeks). | Secondary: Mean Annualized Slope of eGFR Change, To compare the efficacy of tolvaptan treatment in reducing the decline of annualized eGFR slope, as compared with placebo, in subjects with late-stage CKD due to ADPKD who tolerated tolvaptan during an initial run-in period, the annualized rate of eGFR change was derived from each individual subject's eGFR slope using the CKD-EPI formula. The annualized eGFR change slope was derived from all eGFR observations from placebo-run-in, tolvaptan run-in, double-blind treatment and post-treatment follow-up periods using the linear mixed model of analysis. The mean annualized slope of eGFR change is presented., Pretreatment baseline to post-treatment follow-up (up to 61 weeks). | Other: Mean Change From Baseline in Urine Osmolality During the Double-blind Treatment Period and Post-treatment Follow-up, The mean change from baseline in urine osmolality for the double-blind treatment period collection timepoints and post-treatment follow-up are presented. Baseline was defined as the last evaluation prior to post-randomization dosing., Baseline and Months 3, 6, 9 and 12 (End of treatment visit) of the double-blind treatment period, and post-treatment follow-up.|Mean Change From Baseline in Urine Specific Gravity During the Double-blind Treatment Period and Post-treatment Follow-up, The mean change from baseline in urine specific gravity for the double-blind treatment period collection timepoints and post-treatment follow up are presented. Baseline was defined as the last evaluation prior to post-randomization dosing., Baseline and Months 3, 6, 9 and 12 (End of treatment visit) of the double-blind treatment period, and post-treatment follow-up.
Sponsor/Collaborators: Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 1370
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2014-05
Completion Date: 2017-04-18
Results First Posted: 2018-08-08
Last Update Posted: 2018-08-08
Locations: Birmingham, Alabama, 35294, United States|Huntsville, Alabama, 35805, United States|Mobile, Alabama, 36617, United States|Phoenix, Arizona, 85381, United States|Tempe, Arizona, 85284, United States|Tucson, Arizona, 85745, United States|La Jolla, California, 92037, United States|Los Angeles, California, 90022, United States|Los Angeles, California, 90025, United States|San Francisco, California, 94143, United States|Aurora, Colorado, 80045, United States|Denver, Colorado, 80210, United States|New Haven, Connecticut, 06520, United States|Hudson, Florida, 34667, United States|Jacksonville, Florida, 32216, United States|Miami, Florida, 33150, United States|Ocala, Florida, 34471, United States|Port Charlotte, Florida, 33952, United States|Tampa, Florida, 33614, United States|Atlanta, Georgia, 30322, United States|Augusta, Georgia, 30909, United States|Meridian, Idaho, 83642, United States|Chicago, Illinois, 60637, United States|Kansas City, Kansas, 66160, United States|Wichita, Kansas, 67214, United States|Baton Rouge, Louisiana, 70808, United States|Lafayette, Louisiana, 70503, United States|Baltimore, Maryland, 21201, United States|Greenbelt, Maryland, 20770, United States|Rockville, Maryland, 20850, United States|Wheaton, Maryland, 20906, United States|Boston, Massachusetts, 02215, United States|Springfield, Massachusetts, 01107, United States|Detroit, Michigan, 48202, United States|Kalamazoo, Michigan, 49007, United States|Pontiac, Michigan, 48341, United States|Roseville, Michigan, 48066, United States|Minneapolis, Minnesota, 55404, United States|Rochester, Minnesota, 55905, United States|Saint Louis, Missouri, 63110, United States|Las Vegas, Nevada, 89128, United States|Reno, Nevada, 89511, United States|Eatontown, New Jersey, 07724, United States|Voorhees, New Jersey, 08043, United States|Buffalo, New York, 14215, United States|Mineola, New York, 11501, United States|New York, New York, 10016, United States|New York, New York, 10021, United States|New York, New York, 10032, United States|Rosedale, New York, 11422, United States|Asheville, North Carolina, 28801, United States|Chapel Hill, North Carolina, 27599-7155, United States|Charlotte, North Carolina, 28207, United States|Winston-Salem, North Carolina, 27103, United States|Fargo, North Dakota, 58122, United States|Grand Forks, North Dakota, 58201, United States|Akron, Ohio, 44302, United States|Cincinnati, Ohio, 45206, United States|Cleveland, Ohio, 44106, United States|Cleveland, Ohio, 44195, United States|Columbus, Ohio, 43210, United States|Portland, Oregon, 98686, United States|Bethlehem, Pennsylvania, 18017, United States|Doylestown, Pennsylvania, 18901, United States|Philadelphia, Pennsylvania, 19104, United States|Charleston, South Carolina, 29425, United States|Columbia, South Carolina, 29203, United States|Orangeburg, South Carolina, 29118, United States|Knoxville, Tennessee, 39723, United States|Nashville, Tennessee, 37205, United States|Nashville, Tennessee, 37232, United States|Arlington, Texas, 76015, United States|Houston, Texas, 77030-3411, United States|Houston, Texas, 77030, United States|McAllen, Texas, 78503, United States|Burlington, Vermont, 05401, United States|Arlington, Virginia, 22205, United States|Charlottesville, Virginia, 22908, United States|Norfolk, Virginia, 23507, United States|Wenatchee, Washington, 98801, United States|Morgantown, West Virginia, 26506, United States|La Crosse, Wisconsin, 54601, United States|Bahia Blanca, Buenos Aires, B8000FTD, Argentina|Ciudad Autonoma, Buenos Aires, C1093AAS, Argentina|Ciudad Autonoma, Buenos Aires, C1119ACN, Argentina|Ciudad Autonoma, Buenos Aires, C1425APQ, Argentina|Ciudad Autonoma, Buenos Aires, C1429BWN, Argentina|Ciudad Autonoma, Buenos Aires, C1431FWO, Argentina|Junin, Buenos Aires, 6000, Argentina|Pergamino, Buenos Aires, B2700CPM, Argentina|Pilar, Buenos Aires, B1629ODT, Argentina|Sarandi, Buenos Aires, B1872EEA, Argentina|Cordoba, X5000JHQ, Argentina|Cordoba, X5003DCE, Argentina|Cordoba, X5016KEH, Argentina|Camperdown, New South Wales, 2050, Australia|Concord, New South Wales, 2139, Australia|New Lambton Heights, New South Wales, 2305, Australia|St. Leonards, New South Wales, 2065, Australia|Westmead, New South Wales, 2145, Australia|Woolloongabba, Queensland, 4102, Australia|Adelaide, South Australia, 5000, Australia|Launceston, Tasmania, 7250, Australia|Parkville, Victoria, 3050, Australia|Reservoir, Victoria, 3073, Australia|Richmond, Victoria, 3121, Australia|Perth, Western Australia, 6000, Australia|Aalst, 9300, Belgium|Antwerpen, 2650, Belgium|Bruxelles, 1090, Belgium|Bruxelles, 1200, Belgium|Gent, 9000, Belgium|Kortrijk, 8500, Belgium|Leuven, 3000, Belgium|Liège, 400, Belgium|Edmonton, Alberta, T6G 2B7, Canada|St. John's, Newfoundland and Labrador, A1B 3V6, Canada|Scarborough, Ontario, M1H 3G4, Canada|Toronto, Ontario, M4C 5T2, Canada|Toronto, Ontario, M5C 2T2, Canada|Toronto, Ontario, M5G 2N2, Canada|Greenfield Park, Quebec, J4V 2H1, Canada|Montreal, Quebec, H3A 1A1, Canada|Montréal, Quebec, H4J 1C5, Canada|Brno, 625 00, Czechia|Ceske Budejovice, 370 01, Czechia|Hradec Kralove, 500 05, Czechia|Jihlava, 586 33, Czechia|Jilemnice, 51401, Czechia|Liberec, 460 63, Czechia|Ostrava, 708 52, Czechia|Praha 2, 128 08, Czechia|Praha 4, 140 21, Czechia|Tabor, 390 03, Czechia|Aalborg, 9100, Denmark|Aarhus C, 8000, Denmark|Holstebro, 7500, Denmark|Odense C, 5000, Denmark|Viborg, 8800, Denmark|Brest cedex 2, Finistere, 29609, France|Bordeaux Cedex, Gironde, 33000, France|Toulouse Cedex 9, Haute Garonne, 31059, France|Montpellier cedex 5, Herault, 34295, France|Grenoble cedex 9, Isere, 38043, France|Saint-Priest-En-Jarez, Loire, 42055, France|Reims Cedex, Marne, 51090, France|Vandoeuvre les Nancy, Meurthe Et Moselle, 54511, France|Lyon Cedex 03, Rhone, 69437, France|Pierre-Bénite cedex, Rhone, 69495, France|Heidelberg, Baden Wuerttemberg, 69120, Germany|Muenchen, Bayern, 81675, Germany|Nuernberg, Bayern, 90471, Germany|Hannover, Niedersachsen, 30625, Germany|Duesseldorf, Nordrhein Westfalen, 40210, Germany|Essen, Nordrhein Westfalen, 45147, Germany|Wiesbaden, Nordrhein Westfalen, 65191, Germany|Dresden, Sachsen, 01307, Germany|Budapest, 1032, Hungary|Pecs, 7623, Hungary|Szeged, 6720, Hungary|Ashkelon, 7830604, Israel|Jerusalem, 9112001, Israel|Nahariya, 22100, Israel|Petach Tikva, 4941492, Israel|Petaẖ Tiqwa, 4941492, Israel|Ramat-Gan, 52621, Israel|Tel Aviv, 34239, Israel|Torrette Di Ancona, Ancona, 60126, Italy|Montichiari, Brescia, 25018, Italy|Bari, 70124, Italy|Bologna, 40138, Italy|Lecco, 23900, Italy|Milano, 20122, Italy|Milano, 20132, Italy|Modena, 41124, Italy|Napoli, 80131, Italy|Pavia, 27100, Italy|Groningen, 9713 GZ, Netherlands|Nijmegen, 6525 GA, Netherlands|Bergen, 5021, Norway|Oslo, 0424, Norway|Stavanger, 4068, Norway|Ciechanow, 06-400, Poland|Golub Dobrzyn, 87-400, Poland|Kraków, 31-559, Poland|Lodz, 92-213, Poland|Lublin, 20-954, Poland|Warszawa, 04-749, Poland|Wroclaw, 50-556, Poland|Łódź, 92-313, Poland|San Juan, 00918, Puerto Rico|Bucuresti, 011794, Romania|Bucuresti, 022328, Romania|Oradea, 410649, Romania|Krasnoyarsk, 660062, Russian Federation|St. Petersburg, 194044, Russian Federation|St. Petersburg, 197110, Russian Federation|Yaroslavl, 150062, Russian Federation|Pretoria, Gauteng, 0002, South Africa|Durban, KwaZulu-Natal, 4001, South Africa|Cape Town, Western Cape, 7925, South Africa|L'Hospitalet de Llobregat, Barcelona, 08907, Spain|Ciudad Real, 13005, Spain|Madrid, 28041, Spain|Madrid, 28046, Spain|Sevilla, 41009, Spain|Sevilla, 41071, Spain|Valencia, 46017, Spain|Göteborg, 41345, Sweden|Linköping, 58185, Sweden|Stockholm, 141 86, Sweden|Stockholm, 14186, Sweden|Uppsala, 75185, Sweden|Örebro, 70185, Sweden|Exeter, Devon, EX2 5DW, United Kingdom|Hull, East Riding Of Yorkshire, HU3 2JZ, United Kingdom|Brighton, East Sussex, BN2 5BE, United Kingdom|London, Greater London, NW3 2QG, United Kingdom|Manchester, Greater Manchester, M13 9WL, United Kingdom|Salford, Greater Manchester, M6 8HD, United Kingdom|Stevenage, Hertfordshire, SG1 4AB, United Kingdom|Inverness, Highland Region, IV2 3UJ, United Kingdom|Leicester, Leicestershire, LE5 4PW, United Kingdom|Edinburgh, Lothian Region, EH16 4SA, United Kingdom|Liverpool, Merseyside, L7 8XP, United Kingdom|Middlesbrough, North Yorkshire, TS4 3BW, United Kingdom|Sheffield, South Yorkshire, S5 7AU, United Kingdom|Stoke-on-Trent, Staffordshire, ST4 6QG, United Kingdom|Newcastle upon Tyne, Tyne & Wear, NE7 7DN, United Kingdom|Coventry, Warwickshire, CV2 2DX, United Kingdom|Swansea, SA6 6NL, United Kingdom
URL: https://clinicaltrials.gov/show/NCT02160145

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress