Observational Study in Patients With Autosomal Dominant Polycystic Kidney Disease
OVERTURE
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
1 other identifier
observational
3,409
20 countries
266
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2011
Typical duration for all trials
266 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 29, 2011
CompletedFirst Posted
Study publicly available on registry
September 8, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedApril 28, 2026
April 1, 2026
3.3 years
July 29, 2011
April 23, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Correlation of change in total kidney volume with ADPKD-related outcomes
1 year
Secondary Outcomes (5)
Patient-reported pain
every 6 months
SF-12 Scores
every 6 months
ADPKD-Impact Scale Score
every 6 months
Cost of care
every 6 months
EQ-5D Scores
Every 6 months
Study Arms (1)
No treatment
Eligibility Criteria
Subjects will be identified by participating clinics (primarily nephrology clinics) treating patients with ADPKD.
You may qualify if:
- existing diagnosis of ADPKD by modified-Ravine criteria
- Total kidney volume \>= 300 cc/m height by ultrasound or \>= 250 cc/m height by MRI
You may not qualify if:
- Current or expected (within the next six months) interventions for the treatment of ADPKD affecting kidney volume
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (266)
Otsuka Investigational Site 1
Peoria, Arizona, 85381, United States
Otsuka Investigational Site 2
Peoria, Arizona, 85381, United States
Otsuka Investigational Site
Tempe, Arizona, 85284, United States
Otsuka Investigational Site
Azusa, California, 91702, United States
Otsuka Investigational Site
Bakersfield, California, 93308, United States
Otsuka Investigational Site
Los Angeles, California, 90022, United States
Otsuka Investigational Site
Los Angeles, California, 90025, United States
Otsuka Investigational Site
Ontario, California, 91762, United States
Otsuka Investigational Site
San Diego, California, 92108, United States
Otsuka Investigational Site
Arvada, Colorado, 80002, United States
Otsuka Investigational Site
Aurora, Colorado, 80045, United States
Otsuka Investigational Site
Denver, Colorado, 80210, United States
Otsuka Investigational Site
New Haven, Connecticut, 06510, United States
Otsuka Investigational Site
Washington D.C., District of Columbia, 20037, United States
Otsuka Investigational Site
Coral Gables, Florida, 33146, United States
Otsuka Investigational Site
Hudson, Florida, 34667, United States
Otsuka Investigational Site
Jacksonville, Florida, 32216, United States
Otsuka Investigational Site
Melbourne, Florida, 32935, United States
Otsuka Investigational Site
Port Charlotte, Florida, 33952, United States
Otsuka Investigational Site
Tampa, Florida, 33614, United States
Otsuka Investigational Site
Atlanta, Georgia, 30322, United States
Otsuka Investigational Site
Augusta, Georgia, 30901, United States
Otsuka Investigational Site
Meridian, Idaho, 83642, United States
Otsuka Investigational Site
Chicago, Illinois, 60637, United States
Otsuka Investigational Site
Peoria, Illinois, 61602, United States
Otsuka Investigational Site
Mishawaka, Indiana, 46545, United States
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Kansas City, Kansas, 66106, United States
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Wichita, Kansas, 67214, United States
Otsuka Investigational Site
Lexington, Kentucky, 40513, United States
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Paducah, Kentucky, 42003, United States
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New Orleans, Louisiana, 70121, United States
Otsuka Investigational Site
Baltimore, Maryland, 21201, United States
Otsuka Investigational Site
Baltimore, Maryland, 21224, United States
Otsuka Investigational Site
Bethesda, Maryland, 20814, United States
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Rockville, Maryland, 20850, United States
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Rockville, Maryland, 20852, United States
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Wheaton, Maryland, 20906, United States
Otsuka Investigational Site
Boston, Massachusetts, 02111, United States
Otsuka Investigational Site
Boston, Massachusetts, 02215, United States
Otuska Investigational Site
Holyoke, Massachusetts, 01040, United States
Otsuka Investigational Site
Plymouth, Massachusetts, 02360, United States
Otsuka Investigational Site
Springfield, Massachusetts, 01107, United States
Otsuka Investigational Site
Detroit, Michigan, 48236, United States
Otsuka Investigational Site
Kalamazoo, Michigan, 49007, United States
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Pontiac, Michigan, 48341, United States
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Royal Oak, Michigan, 48073, United States
Otsuka Investigational Site
Brooklyn Center, Minnesota, 55430, United States
Otsuka Investigational Site
Rochester, Minnesota, 55905, United States
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St Louis, Missouri, 63110, United States
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Las Vegas, Nevada, 89106, United States
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Las Vegas, Nevada, 89115, United States
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Reno, Nevada, 89511, United States
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Mount Laurel, New Jersey, 08054, United States
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Princeton Junction, New Jersey, 08550, United States
Otsuka Investigational Site
Voorhees Township, New Jersey, 08043, United States
Otsuka Investigational Site
Albuquerque, New Mexico, 87109, United States
Otsuka Investigational Site
Albany, New York, 12208, United States
Otsuka Investigational Site
Brooklyn, New York, 11215, United States
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Buffalo, New York, 14215, United States
Otsuka Investigational Site
Flushing, New York, 11355, United States
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Forest Hills, New York, 11375, United States
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Great Neck, New York, 11021, United States
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Mineola, New York, 11501, United States
Otsuka Investigational Site
New York, New York, 10016, United States
Otsuka Investigational Site
New York, New York, 10021, United States
Otsuka Investigational Site
New York, New York, 10033, United States
Otsuka Investigational Site
Port Washington, New York, 11050, United States
Otsuka Investigational Site
Rochester, New York, 14642, United States
Otsuka Investigational Site
Rosedale, New York, 11422, United States
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The Bronx, New York, 10467, United States
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Chapel Hill, North Carolina, 27599, United States
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Durham, North Carolina, 27705, United States
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Winston-Salem, North Carolina, 27103, United States
Otsuka Investigational Site
Devils Lake, North Dakota, 58301, United States
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Fargo, North Dakota, 58122, United States
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Cincinnati, Ohio, 45267, United States
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Cleveland, Ohio, 44106, United States
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Columbus, Ohio, 43210, United States
Otsuka Investigational Site
Portland, Oregon, 97210, United States
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Altoona, Pennsylvania, 16601, United States
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Bethlehem, Pennsylvania, 18017, United States
Otsuka Investigational Site
Doylestown, Pennsylvania, 18901, United States
Otsuka Investigational Site
Lancaster, Pennsylvania, 17604, United States
Otsuka Investigational Site
Philadelphia, Pennsylvania, 19104, United States
Otsuka Investigational Site
Providence, Rhode Island, 02904, United States
Otsuka Investigational Site
Aiken, South Carolina, 29801, United States
Otsuka Investigational Site
Anderson, South Carolina, 29621, United States
Otsuka Investigational Site
Columbia, South Carolina, 29203, United States
Otsuka Investigational Site
Columbia, South Carolina, 29209, United States
Otsuka Investigational Site
Rapid City, South Dakota, 57701, United States
Otsuka Investigational Site
Knoxville, Tennessee, 37923, United States
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Arlington, Texas, 76015, United States
Otsuka Investigational Site
Fort Worth, Texas, 76104, United States
Otsuka Investigational Site
Houston, Texas, 77004, United States
Otsuka Investigational Site
Houston, Texas, 77030, United States
Otsuka Investigational Site
Mission, Texas, 78572, United States
Otsuka Investigational Site
San Antonio, Texas, 78215, United States
Otsuka Investigational Site
Burlington, Vermont, 05401, United States
Otsuka Investigational Site
Fairfax, Virginia, 22030, United States
Otsuka Investigational Site
Bluefield, West Virginia, 24701, United States
Otsuka Investigational Site
Morgantown, West Virginia, 26506, United States
Otsuka Investigational Site
Madison, Wisconsin, 53713, United States
Otsuka Investigational Site
Avellaneda, Buenos Aires, 1872, Argentina
Otsuka Investigational Site
Junín, Buenos Aires, 6000, Argentina
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La Plata, Buenos Aires, B1902AWL, Argentina
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Pergamino, Buenos Aires, 2700, Argentina
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Pilar, Buenos Aires, B16260DT, Argentina
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Buenos Aires, C.a.b.a., C1429BWN, Argentina
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Buenos Aires, C1181ACH, Argentina
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Buenos Aires, C1425APQ, Argentina
Otsuka Investigational Site
Ciudad de Buenos Aires, C1155AHD, Argentina
Otsuka Investigational Site
Ciudad de Buenos Aires, C1431FWO, Argentina
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Córdoba, X5002HWE, Argentina
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Córdoba, X5016KEH, Argentina
Otsuka Investigational Site
Sante Fe, 3000, Argentina
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Liverpool, New South Wales, 2170, Australia
Otsuka Investigational Site
Newcastle, New South Wales, 2305, Australia
Otsuka Investigational Site
Sydney, New South Wales, 2031, Australia
Otsuka Investigational Site
Sydney, New South Wales, 2050, Australia
Otsuka Investigational Site
Sydney, New South Wales, 2065, Australia
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Sydney, New South Wales, 2139, Australia
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Westmead, New South Wales, 2145, Australia
Otsuka Investigational Site
Adelaide, South Australia, 5000, Australia
Otsuka Investigational Site
Launceston, Tasmania, 7250, Australia
Otsuka Investigational Site
Clayton, Victoria, 3168, Australia
Otsuka Investigational Site
Melbourne, Victoria, 3073, Australia
Otsuka Investigational Site
Parkville, Victoria, 3050, Australia
Otsuka Investigational Site
Richmond, Victoria, 3121, Australia
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Perth, Western Australia, 6000, Australia
Otsuka Investigational Site
Brussels, 1200, Belgium
Otsuka Investigational Site
Ghent, 9000, Belgium
Otsuka Investigational Site
Leuven, 3000, Belgium
Otsuka Investigational Site
Belo Horizonte, Minas Gerais, 30180-060, Brazil
Otsuka Investigational Site
Juiz de Fora, Minas Gerais, 36036-330, Brazil
Otsuka Investigational Site
Curitiba, Paraná, 80440-020, Brazil
Otsuka Investigational Site
Porto Alegre, Rio Grande do Sul, 90020-090, Brazil
Otsuka Investigational Site
Porto Alegre, Rio Grande do Sul, 90035-003, Brazil
Otsuka Investigational Site
Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
Otsuka Investigational Site
Joinville, Santa Catarina, 89227-680, Brazil
Otsuka Investigational Site
São José do Rio Preto, São Paulo, 15015-200, Brazil
Otsuka Investigational Site
São Paulo, São Paulo, 01246-903, Brazil
Otsuka Investigational Site
São Paulo, São Paulo, 01323-001, Brazil
Otsuka Investigational Site
São Paulo, 04038-002, Brazil
Otsuka Investigational Site
Vancouver, British Columbia, V5Z 1M9, Canada
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Vancouver, British Columbia, V6Z 1Y2, Canada
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St. John's, Newfoundland and Labrador, A1B 3V6, Canada
Otsuka Investigational Site
Halifax, Nova Scotia, B3H 1V7, Canada
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Brampton, Ontario, L6Z 4N5, Canada
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Edmonton, Ontario, T6G2B7, Canada
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Oakville, Ontario, L6J 3M5, Canada
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Scarborough Village, Ontario, M1H 3G4, Canada
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Toronto, Ontario, M4C 5T2, Canada
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Toronto, Ontario, M5B 1W8, Canada
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Toronto, Ontario, M5G 2N2, Canada
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Greenfield Park, Quebec, J4V 2H1, Canada
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Montreal, Quebec, H3A 1A1, Canada
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Montreal, Quebec, H3G 1A4, Canada
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Montreal, Quebec, H4J 1C5, Canada
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České Budějovice, 370 01, Czechia
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Hradec Králové, 500 05, Czechia
Otsuka Investigational Site
Jihlava, 586 33, Czechia
Otsuka Investigational Site
Liberec, 460 63, Czechia
Otsuka Investigational Site
Prague, 128 08, Czechia
Otsuka Investigational Site
Caen, 14033, France
Otsuka Investigational Site
Grenoble, 38043, France
Otuska Investigational Site
Lyon, 69437, France
Otsuka Investigational Site
Lyon, 69473, France
Otsuka Investigational Site
Montpellier, 34295, France
Otsuka Investigational Site
Pierre-Bénite, 69495, France
Otsuka Investigational Site
Vandœuvre-lès-Nancy, 54511, France
Otsuka Investigational Site
Berlin, 10117, Germany
Otsuka Investigational Site
Dresden, 01307, Germany
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Düsseldorf, 40210, Germany
Otsuka Investigational Site
Erlangen, 91054, Germany
Otsuka Investigational Site
Hanover, 30625, Germany
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Heidelberg, 69120, Germany
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Munich, 81675, Germany
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Wiesbaden, 65191, Germany
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Rozzano, Milano, 20089, Italy
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Bologna, 40138, Italy
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Lecco, 23900, Italy
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Modena, 41100, Italy
Otsuka Investigational Site
Montichiari, 25018, Italy
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Naples, 80131, Italy
Otsuka Investigational Site
Pavia, 27100, Italy
Otsuka Investigational Site
Sagamihara-shi, Kanagawa, 252-0375, Japan
Otsuka Investigational Site
Kurashiki, Okayama-ken, 701-0192, Japan
Otsuka Investigational Site
Chiba, 260-8712, Japan
Otsuka Investigational Site
Fukuoka, 812-8582, Japan
Otsuka Investigational Site
Hokkaido, 060-8638, Japan
Otsuka Investigational Site
Niigata, 951-8520, Japan
Otsuka Investigational Site
Osaka, 545-8586, Japan
Otsuka Investigational Site
Osaka, 565-0871, Japan
Otsuka Investigational Site
Tochigi, 329-0498, Japan
Otsuka Investigational Site
Tokyo, 113-8510, Japan
Otsuka Investigational Site
Tokyo, 113-8603, Japan
Otsuka Investigational Site
Tokyo, 162-8666, Japan
Otsuka Investigational Site
Tokyo, 173-8606, Japan
Otsuka Investigational Site
Tokyo, 181-8611, Japan
Otsuka Investigational Site
Groningen, 9700RB, Netherlands
Otsuka Investigational Site
Leiden, 2333 ZA, Netherlands
Otsuka Investigational Site
Nijmegen, 6525 GA, Netherlands
Otsuka Investigational Site
Rotterdam, 3015 CE, Netherlands
Otsuka Investigational Site
Drammen, 3004, Norway
Otsuka Investigational Site
Lillehammer, 2609, Norway
Otsuka Investigational Site
Ciechanów, 06-400, Poland
Otsuka Investigational Site
Golub-Dobrzyń, 87-400, Poland
Otsuka Investigational Site
Krakow, 30-663, Poland
Otsuka Investigational Site
Lodz, 93-338, Poland
Otsuka Investigational Site
Radom, 26-610, Poland
Otsuka Investigational Site
Rzeszów, 35-055, Poland
Otsuka Investigational Site
Szczecin, 70-111, Poland
Otsuka Investigational Site
Warsaw, 04-730, Poland
Otsuka Investigational Site
Warsaw, 04-749, Poland
Otsuka Investigational Site
Wroclaw, 50-556, Poland
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Oradea, Bihor County, 410469, Romania
Otsuka Investigational Site
Timișoara, Timiș County, 300736, Romania
Otsuka Investigational Site
Bucharest, 010731, Romania
Otsuka Investigational Site
Bucharest, 022328, Romania
Otsuka Investigational Site
Alicante, 03010, Spain
Otsuka Investigational Site
Barcelona, 08036, Spain
Otsuka Investigational Site
Ciudad Real, 13005, Spain
Otsuka Investigational Site
Hospitalet de Ilobre, 08907, Spain
Otsuka Investigational Site
Madrid, 28046, Spain
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Malmo, 20502, Sweden
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Stockholm, 14186, Sweden
Otsuka Investigational Site
Zurich, 8091, Switzerland
Otsuka Investigational Site
Istanbul, Capa, 34390, Turkey (Türkiye)
Otsuka Investigational Site
Inciraltı, İzmir, 35340, Turkey (Türkiye)
Otsuka Investigational Site
Balcali-Adana, 1330, Turkey (Türkiye)
Otsuka Investigational Site
Bornova-Izmir, 35100, Turkey (Türkiye)
Otsuka Investigational Site
Izmir, 35100, Turkey (Türkiye)
Otsuka Investigational Site
Sihhiye-Ankara, 6100, Turkey (Türkiye)
Otsuka Investigational Site
Exeter, Devon, EX2 5DW, United Kingdom
Otsuka Investigational Site
York, North Yorkshire, YO31 8HE, United Kingdom
Otsuka Investigational Site
Stoke-on-Trent, Staffordshire, ST4 6QG, United Kingdom
Otsuka Investigational Site
Carshalton, Surrey, SM5 1AA, United Kingdom
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Birmingham, West Midlands, B4 6NH, United Kingdom
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Belfast, BT9 7AB, United Kingdom
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Bradford, BD5 0NA, United Kingdom
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Bristol, BS2 8BJ, United Kingdom
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Cambridge, CB2 0QQ, United Kingdom
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Chelmsford, CM1 7ET, United Kingdom
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Coventry, CV2 2DX, United Kingdom
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Dorchester, DT1 2JY, United Kingdom
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Edinburgh, EH16 4SA, United Kingdom
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Hull, HU3 2JZ, United Kingdom
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Inverness, IV2 3UJ, United Kingdom
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Kirkcaldy, KY2 5AH, United Kingdom
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Leicester, LE5 4PW, United Kingdom
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Liverpool, L7 8XP, United Kingdom
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London, NW3 2QG, United Kingdom
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London, SW17 0QT, United Kingdom
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London, WC1N 3JH, United Kingdom
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Manchester, M13 9WL, United Kingdom
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Middlesbrough, TS4 3BW, United Kingdom
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Newcastle upon Tyne, NE7 7DN, United Kingdom
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Oxford, OX3 7LJ, United Kingdom
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Portsmouth, PO6 3LY, United Kingdom
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Preston, PR2 9HT, United Kingdom
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Salford, M6 8HD, United Kingdom
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Sheffield, S5 7AU, United Kingdom
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Southampton, SO16 6YD, United Kingdom
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Stevenage, SG1 4AB, United Kingdom
Otsuka Investigational Site
Westcliff-on-Sea, SS0 0RY, United Kingdom
Otsuka Investigational Site
Wolverhampton, WV10 0QP, United Kingdom
Related Publications (4)
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.
PMID: 39752236DERIVEDLioudis 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.
PMID: 37349694DERIVEDChebib 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.
PMID: 37250503DERIVEDPerrone 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.
PMID: 37180499DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 29, 2011
First Posted
September 8, 2011
Study Start
June 1, 2011
Primary Completion
October 1, 2014
Study Completion
October 1, 2014
Last Updated
April 28, 2026
Record last verified: 2026-04