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
NCT ID: NCT02160145
Last Updated: 2018-08-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1370 participants
INTERVENTIONAL
2014-05-31
2017-04-18
Brief Summary
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Detailed Description
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This trial will compare the efficacy of tolvaptan treatment in reducing the annualized change in estimated glomerular filtration rate (eGFR) from pre-treatment baseline to post-treatment follow-up, as compared with placebo, in subjects who tolerate tolvaptan during an initial run-in period. The change in eGFR, calculated by the Chronic Kidney Disease-Epidemiology (CKD-EPI) formula, will provide kidney function data that are complementary to the data demonstrating the benefits previously observed primarily in ADPKD subjects with earlier stages of disease.
Also, it will compare the efficacy of tolvaptan treatment in reducing the decline of annualized eGFR slope, as compared with placebo, in this type of subjects. Finally, it will compare the overall and hepatic safety profile of tolvaptan with placebo and to compare incidence of ADPKD complications (outcomes) during the trial
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Tolvaptan
Tolvaptan (OPC-41061)
Tolvaptan (OPC-41061)
Tolvaptan tablets (15 or 30 mg) will be self-administered orally as split-dose regimens, once upon awakening and another approximately 8 to 9 hours later.
Placebo
Placebo
Placebo
Matching placebo tablets will be self-administered orally as split-dose regimens, once upon awakening and another approximately 8 to 9 hours later
Interventions
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Tolvaptan (OPC-41061)
Tolvaptan tablets (15 or 30 mg) will be self-administered orally as split-dose regimens, once upon awakening and another approximately 8 to 9 hours later.
Placebo
Matching placebo tablets will be self-administered orally as split-dose regimens, once upon awakening and another approximately 8 to 9 hours later
Eligibility Criteria
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Inclusion Criteria
* Tolvaptan naïve
* Diagnosis of ADPKD by modified pei-Ravine criteria 1) 3 cysts per kidney by sonography or 5 cysts by CT or MRI with family history of ADPKD or 2) 10 cysts per kidney by any radiologic method and exclusion of other cystic kidney diseases if without family history
Exclusion Criteria
* Women who are breast-feeding and/or who have a positive pregnancy test prior to receiving IMP
* Need for chronic diuretic use
* Hepatic impairment or liver function abnormalities other than that expected for ADPKD with typical cystic liver disease
* Advanced diabetes, evidence of additional significant renal disease, renal cancer, single kidney, recent renal surgery or acute kidney injury
* Contraindications to required trial assessments
* Medical history or medical findings inconsistent with safety or compliance with trial assessments
18 Years
65 Years
ALL
No
Sponsors
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Otsuka Pharmaceutical Development & Commercialization, Inc.
INDUSTRY
Responsible Party
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Locations
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Birmingham, Alabama, United States
Huntsville, Alabama, United States
Mobile, Alabama, United States
Phoenix, Arizona, United States
Tempe, Arizona, United States
Tucson, Arizona, United States
La Jolla, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
San Francisco, California, United States
Aurora, Colorado, United States
Denver, Colorado, United States
New Haven, Connecticut, United States
Hudson, Florida, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Ocala, Florida, United States
Port Charlotte, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Augusta, Georgia, United States
Meridian, Idaho, United States
Chicago, Illinois, United States
Kansas City, Kansas, United States
Wichita, Kansas, United States
Baton Rouge, Louisiana, United States
Lafayette, Louisiana, United States
Baltimore, Maryland, United States
Greenbelt, Maryland, United States
Rockville, Maryland, United States
Wheaton, Maryland, United States
Boston, Massachusetts, United States
Springfield, Massachusetts, United States
Detroit, Michigan, United States
Kalamazoo, Michigan, United States
Pontiac, Michigan, United States
Roseville, Michigan, United States
Minneapolis, Minnesota, United States
Rochester, Minnesota, United States
St Louis, Missouri, United States
Las Vegas, Nevada, United States
Reno, Nevada, United States
Eatontown, New Jersey, United States
Voorhees Township, New Jersey, United States
Buffalo, New York, United States
Mineola, New York, United States
New York, New York, United States
New York, New York, United States
New York, New York, United States
Rosedale, New York, United States
Asheville, North Carolina, United States
Chapel Hill, North Carolina, United States
Charlotte, North Carolina, United States
Winston-Salem, North Carolina, United States
Fargo, North Dakota, United States
Grand Forks, North Dakota, United States
Akron, Ohio, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Portland, Oregon, United States
Bethlehem, Pennsylvania, United States
Doylestown, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Charleston, South Carolina, United States
Columbia, South Carolina, United States
Orangeburg, South Carolina, United States
Knoxville, Tennessee, United States
Nashville, Tennessee, United States
Nashville, Tennessee, United States
Arlington, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
McAllen, Texas, United States
Burlington, Vermont, United States
Arlington, Virginia, United States
Charlottesville, Virginia, United States
Norfolk, Virginia, United States
Wenatchee, Washington, United States
Morgantown, West Virginia, United States
La Crosse, Wisconsin, United States
Bahía Blanca, Buenos Aires, Argentina
Ciudad Autonoma, Buenos Aires, Argentina
Ciudad Autonoma, Buenos Aires, Argentina
Ciudad Autonoma, Buenos Aires, Argentina
Ciudad Autonoma, Buenos Aires, Argentina
Ciudad Autonoma, Buenos Aires, Argentina
Junín, Buenos Aires, Argentina
Pergamino, Buenos Aires, Argentina
Pilar, Buenos Aires, Argentina
Sarandí, Buenos Aires, Argentina
Córdoba, , Argentina
Córdoba, , Argentina
Córdoba, , Argentina
Camperdown, New South Wales, Australia
Concord, New South Wales, Australia
New Lambton Heights, New South Wales, Australia
St Leonards, New South Wales, Australia
Westmead, New South Wales, Australia
Woolloongabba, Queensland, Australia
Adelaide, South Australia, Australia
Launceston, Tasmania, Australia
Parkville, Victoria, Australia
Reservoir, Victoria, Australia
Richmond, Victoria, Australia
Perth, Western Australia, Australia
Aalst, , Belgium
Antwerp, , Belgium
Brussels, , Belgium
Brussels, , Belgium
Ghent, , Belgium
Kortrijk, , Belgium
Leuven, , Belgium
Liège, , Belgium
Edmonton, Alberta, Canada
St. John's, Newfoundland and Labrador, Canada
Scarborough Village, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Greenfield Park, Quebec, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Brno, , Czechia
České Budějovice, , Czechia
Hradec Králové, , Czechia
Jihlava, , Czechia
Jilemnice, , Czechia
Liberec, , Czechia
Ostrava, , Czechia
Prague, , Czechia
Prague, , Czechia
Tábor, , Czechia
Aalborg, , Denmark
Aarhus C, , Denmark
Holstebro, , Denmark
Odense C, , Denmark
Viborg, , Denmark
Brest, Finistere, France
Bordeaux, Gironde, France
Toulouse, Haute Garonne, France
Montpellier, Herault, France
Grenoble, Isere, France
Reims, Marne, France
Vandœuvre-lès-Nancy, Meurthe Et Moselle, France
Saint-Priest-En-Jarez, Pays de la Loire Region, France
Lyon, Rhone, France
Pierre-Bénite, Rhone, France
Heidelberg, Baden-Wurttemberg, Germany
Munich, Bavaria, Germany
Nuremberg, Bavaria, Germany
Hanover, Lower Saxony, Germany
Düsseldorf, North Rhine-Westphalia, Germany
Essen, North Rhine-Westphalia, Germany
Wiesbaden, North Rhine-Westphalia, Germany
Dresden, Saxony, Germany
Budapest, , Hungary
Pécs, , Hungary
Szeged, , Hungary
Ashkelon, , Israel
Jerusalem, , Israel
Nahariya, , Israel
Petah Tikva, , Israel
Ramat Gan, , Israel
Tel Aviv, , Israel
Torrette Di Ancona, Ancona, Italy
Montichiari, Brescia, Italy
Bari, , Italy
Bologna, , Italy
Lecco, , Italy
Milan, , Italy
Milan, , Italy
Modena, , Italy
Napoli, , Italy
Pavia, , Italy
Groningen, , Netherlands
Nijmegen, , Netherlands
Bergen, , Norway
Oslo, , Norway
Stavanger, , Norway
Ciechanów, , Poland
Golub-Dobrzyń, , Poland
Krakow, , Poland
Lodz, , Poland
Lodz, , Poland
Lublin, , Poland
Warsaw, , Poland
Wroclaw, , Poland
San Juan, , Puerto Rico
Bucharest, , Romania
Bucharest, , Romania
Oradea, , Romania
Krasnoyarsk, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Yaroslavl, , Russia
Pretoria, Gauteng, South Africa
Durban, KwaZulu-Natal, South Africa
Cape Town, Western Cape, South Africa
L'Hospitalet de Llobregat, Barcelona, Spain
Ciudad Real, , Spain
Madrid, , Spain
Madrid, , Spain
Seville, , Spain
Seville, , Spain
Valencia, , Spain
Gothenburg, , Sweden
Linköping, , Sweden
Örebro, , Sweden
Stockholm, , Sweden
Stockholm, , Sweden
Uppsala, , Sweden
Exeter, Devon, United Kingdom
Hull, East Riding Of Yorkshire, United Kingdom
Brighton, East Sussex, United Kingdom
London, Greater London, United Kingdom
Manchester, Greater Manchester, United Kingdom
Salford, Greater Manchester, United Kingdom
Stevenage, Hertfordshire, United Kingdom
Inverness, Highland Region, United Kingdom
Leicester, Leicestershire, United Kingdom
Edinburgh, Lothian Region, United Kingdom
Liverpool, Merseyside, United Kingdom
Middlesbrough, North Yorkshire, United Kingdom
Sheffield, South Yorkshire, United Kingdom
Stoke-on-Trent, Staffordshire, United Kingdom
Newcastle upon Tyne, Tyne & Wear, United Kingdom
Coventry, Warwickshire, United Kingdom
Swansea, , United Kingdom
Countries
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References
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St Pierre K, Cashmore BA, Bolignano D, Zoccali C, Ruospo M, Craig JC, Strippoli GF, Mallett AJ, Green SC, Tunnicliffe DJ. Interventions for preventing the progression of autosomal dominant polycystic kidney disease. Cochrane Database Syst Rev. 2024 Oct 2;10(10):CD010294. doi: 10.1002/14651858.CD010294.pub3.
Chebib FT, Zhou X, Garbinsky D, Davenport E, Nunna S, Oberdhan D, Fernandes A. Tolvaptan and Kidney Function Decline in Older Individuals With Autosomal Dominant Polycystic Kidney Disease: A Pooled Analysis of Randomized Clinical Trials and Observational Studies. Kidney Med. 2023 Apr 14;5(6):100639. doi: 10.1016/j.xkme.2023.100639. eCollection 2023 Jun.
Alpers DH, Lewis JH, Hunt CM, Freston JW, Torres VE, Li H, Wang W, Hoke ME, Roth SE, Westcott-Baker L, Estilo A. Clinical Pattern of Tolvaptan-Associated Liver Injury in Trial Participants With Autosomal Dominant Polycystic Kidney Disease (ADPKD): An Analysis of Pivotal Clinical Trials. Am J Kidney Dis. 2023 Mar;81(3):281-293.e1. doi: 10.1053/j.ajkd.2022.08.012. Epub 2022 Sep 30.
Bennett H, McEwan P, Hamilton K, O'Reilly K. Modelling the long-term benefits of tolvaptan therapy on renal function decline in autosomal dominant polycystic kidney disease: an exploratory analysis using the ADPKD outcomes model. BMC Nephrol. 2019 Apr 23;20(1):136. doi: 10.1186/s12882-019-1290-5.
Torres VE, Chapman AB, Devuyst O, Gansevoort RT, Perrone RD, Koch G, Ouyang J, McQuade RD, Blais JD, Czerwiec FS, Sergeyeva O; REPRISE Trial Investigators. Tolvaptan in Later-Stage Autosomal Dominant Polycystic Kidney Disease. N Engl J Med. 2017 Nov 16;377(20):1930-1942. doi: 10.1056/NEJMoa1710030. Epub 2017 Nov 4.
Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Other Identifiers
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156-13-210
Identifier Type: -
Identifier Source: org_study_id
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