Observational Study in Patients With Autosomal Dominant Polycystic Kidney Disease

NCT ID: NCT01430494

Last Updated: 2015-04-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3409 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-06-30

Study Completion Date

2014-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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No treatment

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Otsuka Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role collaborator

Otsuka Pharmaceutical Development & Commercialization, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Frank Czerwiec, MD, PhD

Role: STUDY_DIRECTOR

Otsuka Pharmaceutical Development & Commercialization, Inc.

Locations

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Otsuka Investigational Site 1

Peoria, Arizona, United States

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Otsuka Investigational Site 2

Peoria, Arizona, United States

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Tempe, Arizona, United States

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Azusa, California, United States

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Bakersfield, California, United States

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Los Angeles, California, United States

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Los Angeles, California, United States

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Ontario, California, United States

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San Diego, California, United States

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Arvada, Colorado, United States

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Aurora, Colorado, United States

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Denver, Colorado, United States

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New Haven, Connecticut, United States

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Washington D.C., District of Columbia, United States

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Coral Gables, Florida, United States

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Hudson, Florida, United States

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Jacksonville, Florida, United States

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Melbourne, Florida, United States

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Port Charlotte, Florida, United States

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Tampa, Florida, United States

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Atlanta, Georgia, United States

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Augusta, Georgia, United States

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Meridian, Idaho, United States

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Chicago, Illinois, United States

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Peoria, Illinois, United States

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Mishawaka, Indiana, United States

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Kansas City, Kansas, United States

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Wichita, Kansas, United States

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Lexington, Kentucky, United States

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Paducah, Kentucky, United States

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New Orleans, Louisiana, United States

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Baltimore, Maryland, United States

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Baltimore, Maryland, United States

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Bethesda, Maryland, United States

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Rockville, Maryland, United States

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Rockville, Maryland, United States

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Wheaton, Maryland, United States

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Boston, Massachusetts, United States

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Boston, Massachusetts, United States

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Holyoke, Massachusetts, United States

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Plymouth, Massachusetts, United States

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Springfield, Massachusetts, United States

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Detroit, Michigan, United States

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Kalamazoo, Michigan, United States

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Pontiac, Michigan, United States

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Royal Oak, Michigan, United States

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Brooklyn Center, Minnesota, United States

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Rochester, Minnesota, United States

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St Louis, Missouri, United States

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Las Vegas, Nevada, United States

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Las Vegas, Nevada, United States

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Reno, Nevada, United States

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Mount Laurel, New Jersey, United States

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Princeton Junction, New Jersey, United States

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Voorhees Township, New Jersey, United States

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Albuquerque, New Mexico, United States

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Albany, New York, United States

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Brooklyn, New York, United States

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Buffalo, New York, United States

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Flushing, New York, United States

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Forest Hills, New York, United States

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Great Neck, New York, United States

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Mineola, New York, United States

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New York, New York, United States

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Rochester, New York, United States

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Rosedale, New York, United States

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The Bronx, New York, United States

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Chapel Hill, North Carolina, United States

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Durham, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Devils Lake, North Dakota, United States

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Fargo, North Dakota, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Columbus, Ohio, United States

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Portland, Oregon, United States

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Altoona, Pennsylvania, United States

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Bethleham, Pennsylvania, United States

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Doylestown, Pennsylvania, United States

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Lancaster, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Providence, Rhode Island, United States

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Aiken, South Carolina, United States

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Anderson, South Carolina, United States

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Columbia, South Carolina, United States

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Columbia, South Carolina, United States

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Rapid City, South Dakota, United States

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Knoxville, Tennessee, United States

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Arlington, Texas, United States

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Mission, Texas, United States

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Burlington, Vermont, United States

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Fairfax, Virginia, United States

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Bluefield, West Virginia, United States

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Morgantown, West Virginia, United States

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Madison, Wisconsin, United States

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Avellaneda, Buenos Aires, Argentina

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Junín, Buenos Aires, Argentina

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Córdoba, Córdoba Province, Argentina

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Buenos Aires, , Argentina

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Liverpool, New South Wales, Australia

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Newcastle, New South Wales, Australia

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Westmead, New South Wales, Australia

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Adelaide, South Australia, Australia

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Launceston, Tasmania, Australia

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Clayton, Victoria, Australia

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Melbourne, Victoria, Australia

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Parkville, Victoria, Australia

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Richmond, Victoria, Australia

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Perth, Western Australia, Australia

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Brussels, , Belgium

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Ghent, , Belgium

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Leuven, , Belgium

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Belo Horizonte, Minas Gerais, Brazil

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Juiz de Fora, Minas Gerais, Brazil

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Curitiba, Paraná, Brazil

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Porto Alegre, Rio Grande do Sul, Brazil

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Porto Alegre, Rio Grande do Sul, Brazil

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Porto Alegre, Rio Grande do Sul, Brazil

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Joinville, Santa Catarina, Brazil

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São José do Rio Preto, São Paulo, Brazil

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São Paulo, São Paulo, Brazil

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Vancouver, British Columbia, Canada

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Vancouver, British Columbia, Canada

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St. John's, Newfoundland and Labrador, Canada

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Halifax, Nova Scotia, Canada

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Brampton, Ontario, Canada

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Edmonton, Ontario, Canada

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Oakville, Ontario, Canada

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Scarborough Village, Ontario, Canada

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Toronto, Ontario, Canada

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Greenfield Park, Quebec, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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České Budějovice, , Czechia

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Hradec Králové, , Czechia

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Jihlava, , Czechia

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Liberec, , Czechia

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Prague, , Czechia

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Caen, , France

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Grenoble, , France

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Lyon, , France

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Lyon, , France

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Montpellier, , France

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Pierre-Bénite, , France

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Vandœuvre-lès-Nancy, , France

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Berlin, , Germany

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Dresden, , Germany

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Düsseldorf, , Germany

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Erlangen, , Germany

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Heidelberg, , Germany

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Munich, , Germany

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Wiesbaden, , Germany

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Rozzano, Milano, Italy

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Bologna, , Italy

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Lecco, , Italy

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Modena, , Italy

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Montichiari, (Brescia), , Italy

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Napoli, , Italy

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Pavia, , Italy

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Sagamihara-shi, Kanagawa, Japan

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Kurashiki, Okayama-ken, Japan

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Chiba, , Japan

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Fukuoka, , Japan

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Hokkaido, , Japan

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Niigata, , Japan

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Osaka, , Japan

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Tochigi, , Japan

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Tokyo, , Japan

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Tokyo, , Japan

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Tokyo, , Japan

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Tokyo, , Japan

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Tokyo, , Japan

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Groningen, , Netherlands

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Leiden, , Netherlands

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Nijmegen, , Netherlands

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Rotterdam, , Netherlands

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Drammen, , Norway

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Lillehammer, , Norway

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Ciechanów, , Poland

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Golub-Dobrzyń, , Poland

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Krakow, , Poland

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Lodz, , Poland

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Radom, , Poland

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Wroclaw, , Poland

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Oradea, Bihor County, Romania

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Timișoara, Timiș County, Romania

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Bucharest, , Romania

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Bucharest, , Romania

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Alicante, , Spain

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Barcelona, , Spain

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Ciudad Real, , Spain

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Hospitalet de Ilobre, , Spain

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Madrid, , Spain

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Malmo, , Sweden

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Stockholm, , Sweden

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Zurich, , Switzerland

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Istanbul, Capa, Turkey (Türkiye)

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Inciraltı, İzmir, Turkey (Türkiye)

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Balcali-Adana, , Turkey (Türkiye)

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Bornova-Izmir, , Turkey (Türkiye)

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Izmir, , Turkey (Türkiye)

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Sihhiye-Ankara, , Turkey (Türkiye)

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Exeter, Devon, United Kingdom

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York, North Yorkshire, United Kingdom

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Stoke-on-Trent, Staffordshire, United Kingdom

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Carshalton, Surrey, United Kingdom

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Birmingham, West Midlands, United Kingdom

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Belfast, , United Kingdom

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Bradford, , United Kingdom

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Chelmsford, , United Kingdom

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Hull, , United Kingdom

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Inverness, , United Kingdom

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Kirkcaldy, , United Kingdom

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Leicester, , United Kingdom

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Liverpool, , United Kingdom

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London, , United Kingdom

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London, , United Kingdom

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London, , United Kingdom

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Manchester, , United Kingdom

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Middlesbrough, , United Kingdom

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Newcastle upon Tyne, , United Kingdom

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Oxford, , United Kingdom

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Portsmouth, , United Kingdom

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Preston, , United Kingdom

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Salford, , United Kingdom

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Sheffield, , United Kingdom

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Southampton, , United Kingdom

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Stevenage, , United Kingdom

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Westcliff-on-Sea, , United Kingdom

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Wolverhampton, , United Kingdom

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Countries

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United States Argentina Australia Belgium Brazil Canada Czechia France Germany Italy Japan Netherlands Norway Poland Romania Spain Sweden Switzerland Turkey (Türkiye) United Kingdom

References

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Gitomer BY, Chonchol M, Zhou X, Garbinsky D, Wang J, Nunna S, Fernandes AW, Oberdhan D. Kidney Stone Disease and Progression Risk in Autosomal Dominant Polycystic Kidney Disease: A Post Hoc Analysis of OVERTURE. Kidney360. 2024 Sep 1;5(9):1364-1366. doi: 10.34067/KID.0000000000000524. Epub 2024 Jul 24. No abstract available.

Reference Type DERIVED
PMID: 39752236 (View on PubMed)

Lioudis M, Zhou X, Davenport E, Nunna S, Krasa HB, Oberdhan D, Fernandes AW. Effects of tolvaptan discontinuation in patients with autosomal dominant polycystic kidney disease: a post hoc pooled analysis. BMC Nephrol. 2023 Jun 22;24(1):182. doi: 10.1186/s12882-023-03247-6.

Reference Type DERIVED
PMID: 37349694 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37250503 (View on PubMed)

Perrone RD, Oberdhan D, Ouyang J, Bichet DG, Budde K, Chapman AB, Gitomer BY, Horie S, Ong ACM, Torres VE, Turner AN, Krasa H. OVERTURE: A Worldwide, Prospective, Observational Study of Disease Characteristics in Patients With ADPKD. Kidney Int Rep. 2023 Feb 13;8(5):989-1001. doi: 10.1016/j.ekir.2023.02.1073. eCollection 2023 May.

Reference Type DERIVED
PMID: 37180499 (View on PubMed)

Other Identifiers

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156-10-291

Identifier Type: -

Identifier Source: org_study_id

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