Autosomal Dominant Polycystic Kidney Disease (ADPKD) Clinical Trial
— OVERTUREOfficial title:
A Multi-center, Longitudinal, Observational Study of Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) to Establish the Rate, Characteristics, and Determinants of Disease Progression
To collect characteristics of patients with ADPKD across a broad population, over time to better understand disease progression (signs, symptoms and outcomes). Association with total kidney volume changes and other measures of disease progression will be determined in order to identify a population at increased risk for disease progression. The economic and quality life impact of ADPKD will be assessed. Subjects who terminated participation early from clinical trials with tolvaptan may also be followed.
| Status | Completed |
| Enrollment | 3409 |
| Est. completion date | October 2014 |
| Est. primary completion date | October 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 12 Years to 70 Years |
| Eligibility |
Inclusion Criteria: - existing diagnosis of ADPKD by modified-Ravine criteria - Total kidney volume >= 300 cc/m height by ultrasound or >= 250 cc/m height by MRI Exclusion Criteria: - Current or expected (within the next six months) interventions for the treatment of ADPKD affecting kidney volume |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Otsuka Investigational Site | Avellaneda | Buenos Aires |
| Argentina | Otsuka Investigational Site | Ciudad Autonoma de Buenos Aires | |
| Argentina | Otsuka Investigational Site | Ciudad Autonoma de Buenos Aires | |
| Argentina | Otsuka Investigational Site | Ciudad Autónoma de Buenos Aires | C.a.b.a. |
| Argentina | Otsuka Investigational Site | Ciudad de Buenos Aires | |
| Argentina | Otsuka Investigational Site | Ciudad de Buenos Aires | |
| Argentina | Otsuka Investigational Site | Cordoba | |
| Argentina | Otsuka Investigational Site | Cordoba | |
| Argentina | Otsuka Investigational Site | Junin | Buenos Aires |
| Argentina | Otsuka Investigational Site | La Plata | Buenos Aires |
| Argentina | Otsuka Investigational Sites | Pergamino | Buenos Aires |
| Argentina | Otsuka Investigational Site | Pilar | Buenos Aires |
| Argentina | Otsuka Investigational Site | Sante Fe | |
| Australia | Otsuka Investigational Site | Adelaide | South Australia |
| Australia | Otsuka Investigational Site | Clayton | Victoria |
| Australia | Otsuka Investigational Site | Launceston | Tasmania |
| Australia | Otsuka Investigational Site | Liverpool | New South Wales |
| Australia | Otsuka Investigational Site | Melbourne | Victoria |
| Australia | Otsuka Investigational Site | Newcastle | New South Wales |
| Australia | Otsuka Investigational Site | Parkville | Victoria |
| Australia | Otsuka Investigational Site | Perth | Western Australia |
| Australia | Otsuka Investigational Site | Richmond | Victoria |
| Australia | Otsuka Investigational Site | Sydney | New South Wales |
| Australia | Otsuka Investigational Site | Sydney | New South Wales |
| Australia | Otsuka Investigational Site | Sydney | New South Wales |
| Australia | Otsuka Investigational Site | Sydney | New South Wales |
| Australia | Otsuka Investigational Site | Westmead | New South Wales |
| Belgium | Otsuka Investigational Site | Brussels | |
| Belgium | Otsuka Investigational Site | Gent | |
| Belgium | Otsuka Investigational Site | Leuven | |
| Brazil | Otsuka Investigational Site | Belo Horizonte | MG |
| Brazil | Otsuka Investigational Site | Curitiba | PR |
| Brazil | Otsuka Investigational Site | Joinville | SC |
| Brazil | Otsuka Investigational Site | Juiz De Fora | MG |
| Brazil | Otsuka Investigational Site | Porto Alegre | RS |
| Brazil | Otsuka Investigational Site | Porto Alegre | RS |
| Brazil | Otsuka Investigational Site | Porto Alegre | RS |
| Brazil | Otsuka Investigational Site | São José do Rio Preto | SP |
| Brazil | Otsuka Investigational Site | São Paulo | SP |
| Brazil | Otsuka Investigational Site | São Paulo | SP |
| Brazil | Otsuka Investigational Site | São Paulo | |
| Canada | Otsuka Investigational Site | Brampton | Ontario |
| Canada | Otsuka Investigational Site | Edmonton | Ontario |
| Canada | Otsuka Investigational Site | Greenfield Park | Quebec |
| Canada | Otsuka Investigational Site | Halifax | Nova Scotia |
| Canada | Otsuka Investigational Site | Montreal | Quebec |
| Canada | Otsuka Investigational Site | Montreal | Quebec |
| Canada | Otsuka Investigational Site | Montreal | Quebec |
| Canada | Otsuka Investigational Site | Oakville | Ontario |
| Canada | Otsuka Investigational Site | Scarborough | Ontario |
| Canada | Otsuka Investigational Site | St. John's | Newfoundland and Labrador |
| Canada | Otsuka Investigational Site | Toronto | Ontario |
| Canada | Otsuka Investigational Site | Toronto | Ontario |
| Canada | Otsuka Investigational Site | Toronto | Ontario |
| Canada | Otsuka Investigational Site | Vancouver | British Columbia |
| Canada | Otsuka Investigational Site | Vancouver | British Columbia |
| Czech Republic | Otsuka Investigational Site | Ceske Budejovice | |
| Czech Republic | Otsuka Investigational Site | Hradec Kralove | |
| Czech Republic | Otsuka Investigational Site | Jihlava | |
| Czech Republic | Otsuka Investigational Site | Liberec | |
| Czech Republic | Otsuka Investigational Site | Praha 2 | |
| France | Otsuka Investigational Site | Caen cedex 9 | |
| France | Otsuka Investigational Site | Grenoble cedex | |
| France | Otsuka Investigational Site | Lyon cedex 03 | |
| France | Otuska Investigational Site | Lyon cedex 3 | |
| France | Otsuka Investigational Site | Montpellier cedex | |
| France | Otsuka Investigational Site | Pierre-Bénite cedex | |
| France | Otsuka Investigational Site | Vandoeuvre-lès-Nancy cedex | |
| Germany | Otsuka Investigational Site | Berlin | |
| Germany | Otsuka Investigational Site | Dresden | |
| Germany | Otsuka Investigational Site | Düsseldorf | |
| Germany | Otsuka Investigational Site | Erlangen | |
| Germany | Otsuka Investigational Site | Hannover | |
| Germany | Otsuka Investigational Site | Heidelburg | |
| Germany | Otsuka Investigational Site | Munich | |
| Germany | Otsuka Investigational Site | Wiesbaden | |
| Italy | Otsuka Investigational Site | Bologna | |
| Italy | Otsuka Investigational Site | Lecco | |
| Italy | Otsuka Investigational Site | Modena | |
| Italy | Otsuka Investigational Site | Montichiari, (Brescia) | |
| Italy | Otsuka Investigational Site | Napoli | |
| Italy | Otsuka Investigational Site | Pavia | |
| Italy | Otsuka Investigational Site | Rozzano | Milano |
| Japan | Otsuka Investigational Site | Chiba | |
| Japan | Otsuka Investigational Site | Fukuoka | |
| Japan | Otsuka Investigational Site | Hokkaido | |
| Japan | Otsuka Investigational Site | Kurashiki-city | Okayama |
| Japan | Otsuka Investigational Site | Niigata | |
| Japan | Otsuka Investigational Site | Osaka | |
| Japan | Otsuka Investigational Site | Osaka | |
| Japan | Otsuka Investigational Site | Sagamihara-shi | Kanagawa |
| Japan | Otsuka Investigational Site | Tochigi | |
| Japan | Otsuka Investigational Site | Tokyo | |
| Japan | Otsuka Investigational Site | Tokyo | |
| Japan | Otsuka Investigational Site | Tokyo | |
| Japan | Otsuka Investigational Site | Tokyo | |
| Japan | Otsuka Investigational Site | Tokyo | |
| Netherlands | Otsuka Investigational Site | Groningen | |
| Netherlands | Otsuka Investigational Site | Leiden | |
| Netherlands | Otsuka Investigational Site | Nijmegen | |
| Netherlands | Otsuka Investigational Site | Rotterdam | |
| Norway | Otsuka Investigational Site | Drammen | |
| Norway | Otsuka Investigational Site | Lillehammer | |
| Poland | Otsuka Investigational Site | Ciechanow | |
| Poland | Otsuka Investigational Site | Golub-Dobrzyn | |
| Poland | Otsuka Investigational Site | Krakow | |
| Poland | Otsuka Investigational Site | Lodz | |
| Poland | Otsuka Investigational Site | Radom | |
| Poland | Otsuka Investigational Site | Rzeszów | |
| Poland | Otsuka Investigational Site | Szczecin | |
| Poland | Otsuka Investigational Site | Warsaw | |
| Poland | Otsuka Investigational Site | Warszawa | |
| Poland | Otsuka Investigational Site | Wroclaw | |
| Romania | Otsuka Investigational Site | Bucuresti | |
| Romania | Otsuka Investigational Site | Bucuresti | |
| Romania | Otsuka Investigational Site | Oradea | Bihor |
| Romania | Otsuka Investigational Site | Timisoara | Timis |
| Spain | Otsuka Investigational Site | Alicante | |
| Spain | Otsuka Investigational Site | Barcelona | |
| Spain | Otsuka Investigational Site | Ciudad Real | |
| Spain | Otsuka Investigational Site | Hospitalet de Ilobre | |
| Spain | Otsuka Investigational Site | Madrid | |
| Sweden | Otsuka Investigational Site | Malmö | |
| Sweden | Otsuka Investigational Site | Stockholm | |
| Switzerland | Otsuka Investigational Site | Zürich | |
| Turkey | Otsuka Investigational Site | Balcali-Adana | |
| Turkey | Otsuka Investigational Site | Bornova-Izmir | |
| Turkey | Otsuka Investigational Site | Inciralti | Izmir |
| Turkey | Otsuka Investigational Site | Istanbul | Capa |
| Turkey | Otsuka Investigational Site | Izmir | |
| Turkey | Otsuka Investigational Site | Sihhiye-Ankara | |
| United Kingdom | Otsuka Investigational Site | Belfast | |
| United Kingdom | Otsuka Investigational Site | Birmingham | West Midlands |
| United Kingdom | Otsuka Investigational Site | Bradford | |
| United Kingdom | Otsuka Investigational Site | Bristol | |
| United Kingdom | Otsuka Investigational Site | Cambridge | |
| United Kingdom | Otsuka Investigational Site | Carshalton | Surrey |
| United Kingdom | Otsuka Investigational Site | Chelmsford | |
| United Kingdom | Otsuka Investigational Site | Coventry | |
| United Kingdom | Otsuka Investigational Site | Dorchester | |
| United Kingdom | Otsuka Investigational Site | Edinburgh | |
| United Kingdom | Otsuka Investigational Site | Exeter | Devon |
| United Kingdom | Otsuka Investigational Site | Hull | |
| United Kingdom | Otsuka Investigational Site | Inverness | |
| United Kingdom | Otsuka Investigational Site | Kirkcaldy | |
| United Kingdom | Otsuka Investigational Site | Leicester | |
| United Kingdom | Otsuka Investigational Site | Liverpool | |
| United Kingdom | Otsuka Investigational Site | London | |
| United Kingdom | Otsuka Investigational Site | London | |
| United Kingdom | Otsuka Investigational Site | London | |
| United Kingdom | Otsuka Investigational Site | Manchester | |
| United Kingdom | Otsuka Investigational Site | Middlesbrough | |
| United Kingdom | Otsuka Investigational Site | Newcastle Upon Tyne | |
| United Kingdom | Otsuka Investigational Site | Oxford | |
| United Kingdom | Otsuka Investigational Site | Portsmouth | |
| United Kingdom | Otsuka Investigational Site | Preston | |
| United Kingdom | Otsuka Investigational Site | Salford | |
| United Kingdom | Otsuka Investigational Site | Sheffield | |
| United Kingdom | Otsuka Investigational Site | Southampton | |
| United Kingdom | Otsuka Investigational Site | Stevenage | |
| United Kingdom | Otsuka Investigational Site | Stoke-on-Trent | Staffordshire |
| United Kingdom | Otsuka Investigational Site | Westcliff-on-Sea | |
| United Kingdom | Otsuka Investigational Site | Wolverhampton | |
| United Kingdom | Otsuka Investigational Site | York | North Yorkshire |
| United States | Otsuka Investigational Site | Aiken | South Carolina |
| United States | Otsuka Investigational Site | Albany | New York |
| United States | Otsuka Investigational Site | Alburquerque | New Mexico |
| United States | Otsuka Investigational Site | Altoona | Pennsylvania |
| United States | Otsuka Investigational Site | Anderson | South Carolina |
| United States | Otsuka Investigational Site | Arlington | Texas |
| United States | Otsuka Investigational Site | Arvada | Colorado |
| United States | Otsuka Investigational Site | Atlanta | Georgia |
| United States | Otsuka Investigational Site | Augusta | Georgia |
| United States | Otsuka Investigational Site | Aurora | Colorado |
| United States | Otsuka Investigational Site | Azusa | California |
| United States | Otsuka Investigational Site | Bakersfield | California |
| United States | Otsuka Investigational Site | Baltimore | Maryland |
| United States | Otsuka Investigational Site | Baltimore | Maryland |
| United States | Otsuka Investigational Site | Bethesda | Maryland |
| United States | Otsuka Investigational Site | Bethleham | Pennsylvania |
| United States | Otsuka Investigational Site | Bluefield | West Virginia |
| United States | Otsuka Investigational Site | Boston | Massachusetts |
| United States | Otsuka Investigational Site | Boston | Massachusetts |
| United States | Otsuka Investigational Site | Bronx | New York |
| United States | Otsuka Investigational Site | Brooklyn | New York |
| United States | Otsuka Investigational Site | Brooklyn Center | Minnesota |
| United States | Otsuka Investigational Site | Buffalo | New York |
| United States | Otsuka Investigational Site | Burlington | Vermont |
| United States | Otsuka Investigational Site | Chapel Hill | North Carolina |
| United States | Otsuka Investigational Site | Chicago | Illinois |
| United States | Otsuka Investigational Site | Cincinnati | Ohio |
| United States | Otsuka Investigational Site | Cleveland | Ohio |
| United States | Otsuka Investigational Site | Columbia | South Carolina |
| United States | Otsuka Investigational Site | Columbia | South Carolina |
| United States | Otsuka Investigational Site | Columbus | Ohio |
| United States | Otsuka Investigational Site | Coral Gables | Florida |
| United States | Otsuka Investigational Site | Denver | Colorado |
| United States | Otsuka Investigational Site | Detroit | Michigan |
| United States | Otsuka Investigational Site | Devils Lake | North Dakota |
| United States | Otsuka Investigational Site | Doylestown | Pennsylvania |
| United States | Otsuka Investigational Site | Durham | North Carolina |
| United States | Otsuka Investigational Site | Fairfax | Virginia |
| United States | Otsuka Investigational Site | Fargo | North Dakota |
| United States | Otsuka Investigational Site | Flushing | New York |
| United States | Otsuka Investigational Site | Forest Hills | New York |
| United States | Otsuka Investigational Site | Fort Worth | Texas |
| United States | Otsuka Investigational Site | Great Neck | New York |
| United States | Otuska Investigational Site | Holyoke | Massachusetts |
| United States | Otsuka Investigational Site | Houston | Texas |
| United States | Otsuka Investigational Site | Houston | Texas |
| United States | Otsuka Investigational Site | Hudson | Florida |
| United States | Otsuka Investigational Site | Jacksonville | Florida |
| United States | Otsuka Investigational Site | Kalamazoo | Michigan |
| United States | Otsuka Investigational Site | Kansas City | Kansas |
| United States | Otsuka Investigational Site | Knoxville | Tennessee |
| United States | Otsuka Investigational Site | Lancaster | Pennsylvania |
| United States | Otsuka Investigational Site | Las Vegas | Nevada |
| United States | Otsuka Investigational Site | Las Vegas | Nevada |
| United States | Otsuka Investigational Site | Lexington | Kentucky |
| United States | Otsuka Investigational Site | Los Angeles | California |
| United States | Otsuka Investigational Site | Los Angeles | California |
| United States | Otsuka Investigational Site | Madison | Wisconsin |
| United States | Otsuka Investigational Site | Melbourne | Florida |
| United States | Otsuka Investigational Site | Meridian | Idaho |
| United States | Otsuka Investigational Site | Mineola | New York |
| United States | Otsuka Investigational Site | Mishawaka | Indiana |
| United States | Otsuka Investigational Site | Mission | Texas |
| United States | Otsuka Investigational Site | Morgantown | West Virginia |
| United States | Otsuka Investigational Site | Mount Laurel | New Jersey |
| United States | Otsuka Investigational Site | New Haven | Connecticut |
| United States | Otsuka Investigational Site | New Orleans | Louisiana |
| United States | Otsuka Investigational Site | New York | New York |
| United States | Otsuka Investigational Site | New York | New York |
| United States | Otsuka Investigational Site | New York | New York |
| United States | Otsuka Investigational Site | Ontario | California |
| United States | Otsuka Investigational Site | Paducah | Kentucky |
| United States | Otsuka Investigational Site | Peoria | Illinois |
| United States | Otsuka Investigational Site 1 | Peoria | Arizona |
| United States | Otsuka Investigational Site 2 | Peoria | Arizona |
| United States | Otsuka Investigational Site | Philadelphia | Pennsylvania |
| United States | Otsuka Investigational Site | Plymouth | Massachusetts |
| United States | Otsuka Investigational Site | Pontiac | Michigan |
| United States | Otsuka Investigational Site | Port Charlotte | Florida |
| United States | Otsuka Investigational Site | Port Washington | New York |
| United States | Otsuka Investigational Site | Portland | Oregon |
| United States | Otsuka Investigational Site | Princeton Junction | New Jersey |
| United States | Otsuka Investigational Site | Providence | Rhode Island |
| United States | Otsuka Investigational Site | Rapid City | South Dakota |
| United States | Otsuka Investigational Site | Reno | Nevada |
| United States | Otsuka Investigational Site | Rochester | Minnesota |
| United States | Otsuka Investigational Site | Rochester | New York |
| United States | Otsuka Investigational Site | Rockville | Maryland |
| United States | Otsuka Investigational Site | Rockville | Maryland |
| United States | Otsuka Investigational Site | Rosedale | New York |
| United States | Otsuka Investigational Site | Royal Oak | Michigan |
| United States | Otsuka Investigational Site | San Antonio | Texas |
| United States | Otsuka Investigational Site | San Diego | California |
| United States | Otsuka Investigational Site | Springfield | Massachusetts |
| United States | Otsuka Investigational Site | St. Louis | Missouri |
| United States | Otsuka Investigational Site | Tampa | Florida |
| United States | Otsuka Investigational Site | Tempe | Arizona |
| United States | Otsuka Investigational Site | Voorhees | New Jersey |
| United States | Otsuka Investigational Site | Washington | District of Columbia |
| United States | Otsuka Investigational Site | Wheaton | Maryland |
| United States | Otsuka Investigational Site | Wichita | Kansas |
| United States | Otsuka Investigational Site | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka Pharmaceutical Co., Ltd. |
United States, Argentina, Australia, Belgium, Brazil, Canada, Czech Republic, France, Germany, Italy, Japan, Netherlands, Norway, Poland, Romania, Spain, Sweden, Switzerland, Turkey, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Correlation of change in total kidney volume with ADPKD-related outcomes | 1 year | No | |
| Secondary | Patient-reported pain | every 6 months | No | |
| Secondary | SF-12 Scores | every 6 months | No | |
| Secondary | ADPKD-Impact Scale Score | every 6 months | No | |
| Secondary | Cost of care | every 6 months | No | |
| Secondary | EQ-5D Scores | Every 6 months | No |
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