Observational Study in Patients With Autosomal Dominant Polycystic Kidney Disease (OVERTURE)

April 23, 2026 updated by: Otsuka Pharmaceutical Development & Commercialization, Inc.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3409

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1425APQ
        • Otsuka Investigational Site
      • Buenos Aires, Argentina, C1181ACH
        • Otsuka Investigational Site
      • Ciudad de Buenos Aires, Argentina, C1155AHD
        • Otsuka Investigational Site
      • Ciudad de Buenos Aires, Argentina, C1431FWO
        • Otsuka Investigational Site
      • Córdoba, Argentina, X5016KEH
        • Otsuka Investigational Site
      • Córdoba, Argentina, X5002HWE
        • Otsuka Investigational Site
      • Sante Fe, Argentina, 3000
        • Otsuka Investigational Site
    • Buenos Aires
      • Avellaneda, Buenos Aires, Argentina, 1872
        • Otsuka Investigational Site
      • Junín, Buenos Aires, Argentina, 6000
        • Otsuka Investigational Site
      • La Plata, Buenos Aires, Argentina, B1902AWL
        • Otsuka Investigational Site
      • Pergamino, Buenos Aires, Argentina, 2700
        • Otsuka Investigational Sites
      • Pilar, Buenos Aires, Argentina, B16260DT
        • Otsuka Investigational Site
    • C.a.b.a.
      • Buenos Aires, C.a.b.a., Argentina, C1429BWN
        • Otsuka Investigational Site
  • Australia
    • New South Wales
      • Liverpool, New South Wales, Australia, 2170
        • Otsuka Investigational Site
      • Newcastle, New South Wales, Australia, 2305
        • Otsuka Investigational Site
      • Sydney, New South Wales, Australia, 2031
        • Otsuka Investigational Site
      • Sydney, New South Wales, Australia, 2050
        • Otsuka Investigational Site
      • Sydney, New South Wales, Australia, 2065
        • Otsuka Investigational Site
      • Sydney, New South Wales, Australia, 2139
        • Otsuka Investigational Site
      • Westmead, New South Wales, Australia, 2145
        • Otsuka Investigational Site
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Otsuka Investigational Site
    • Tasmania
      • Launceston, Tasmania, Australia, 7250
        • Otsuka Investigational Site
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Otsuka Investigational Site
      • Melbourne, Victoria, Australia, 3073
        • Otsuka Investigational Site
      • Parkville, Victoria, Australia, 3050
        • Otsuka Investigational Site
      • Richmond, Victoria, Australia, 3121
        • Otsuka Investigational Site
    • Western Australia
      • Perth, Western Australia, Australia, 6000
        • Otsuka Investigational Site
  • Belgium
      • Brussels, Belgium, 1200
        • Otsuka Investigational Site
      • Ghent, Belgium, 9000
        • Otsuka Investigational Site
      • Leuven, Belgium, 3000
        • Otsuka Investigational Site
  • Brazil
      • São Paulo, Brazil, 04038-002
        • Otsuka Investigational Site
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30180-060
        • Otsuka Investigational Site
      • Juiz de Fora, Minas Gerais, Brazil, 36036-330
        • Otsuka Investigational Site
    • Paraná
      • Curitiba, Paraná, Brazil, 80440-020
        • Otsuka Investigational Site
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90020-090
        • Otsuka Investigational Site
      • Porto Alegre, Rio Grande do Sul, Brazil, 90035-003
        • Otsuka Investigational Site
      • Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
        • Otsuka Investigational Site
    • Santa Catarina
      • Joinville, Santa Catarina, Brazil, 89227-680
        • Otsuka Investigational Site
    • São Paulo
      • São José do Rio Preto, São Paulo, Brazil, 15015-200
        • Otsuka Investigational Site
      • São Paulo, São Paulo, Brazil, 01246-903
        • Otsuka Investigational Site
      • São Paulo, São Paulo, Brazil, 01323-001
        • Otsuka Investigational Site
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Otsuka Investigational Site
      • Vancouver, British Columbia, Canada, V6Z 1Y2
        • Otsuka Investigational Site
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1B 3V6
        • Otsuka Investigational Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V7
        • Otsuka Investigational Site
    • Ontario
      • Brampton, Ontario, Canada, L6Z 4N5
        • Otsuka Investigational Site
      • Edmonton, Ontario, Canada, T6G2B7
        • Otsuka Investigational Site
      • Oakville, Ontario, Canada, L6J 3M5
        • Otsuka Investigational Site
      • Scarborough Village, Ontario, Canada, M1H 3G4
        • Otsuka Investigational Site
      • Toronto, Ontario, Canada, M4C 5T2
        • Otsuka Investigational Site
      • Toronto, Ontario, Canada, M5B 1W8
        • Otsuka Investigational Site
      • Toronto, Ontario, Canada, M5G 2N2
        • Otsuka Investigational Site
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V 2H1
        • Otsuka Investigational Site
      • Montreal, Quebec, Canada, H3A 1A1
        • Otsuka Investigational Site
      • Montreal, Quebec, Canada, H3G 1A4
        • Otsuka Investigational Site
      • Montreal, Quebec, Canada, H4J 1C5
        • Otsuka Investigational Site
  • Czechia
      • Hradec Králové, Czechia, 500 05
        • Otsuka Investigational Site
      • Jihlava, Czechia, 586 33
        • Otsuka Investigational Site
      • Liberec, Czechia, 460 63
        • Otsuka Investigational Site
      • Prague, Czechia, 128 08
        • Otsuka Investigational Site
      • České Budějovice, Czechia, 370 01
        • Otsuka Investigational Site
  • France
      • Caen, France, 14033
        • Otsuka Investigational Site
      • Grenoble, France, 38043
        • Otsuka Investigational Site
      • Lyon, France, 69437
        • Otuska Investigational Site
      • Lyon, France, 69473
        • Otsuka Investigational Site
      • Montpellier, France, 34295
        • Otsuka Investigational Site
      • Pierre-Bénite, France, 69495
        • Otsuka Investigational Site
      • Vandœuvre-lès-Nancy, France, 54511
        • Otsuka Investigational Site
  • Germany
      • Berlin, Germany, 10117
        • Otsuka Investigational Site
      • Dresden, Germany, 01307
        • Otsuka Investigational Site
      • Düsseldorf, Germany, 40210
        • Otsuka Investigational Site
      • Erlangen, Germany, 91054
        • Otsuka Investigational Site
      • Hanover, Germany, 30625
        • Otsuka Investigational Site
      • Heidelberg, Germany, 69120
        • Otsuka Investigational Site
      • Munich, Germany, 81675
        • Otsuka Investigational Site
      • Wiesbaden, Germany, 65191
        • Otsuka Investigational Site
  • Italy
      • Bologna, Italy, 40138
        • Otsuka Investigational Site
      • Lecco, Italy, 23900
        • Otsuka Investigational Site
      • Modena, Italy, 41100
        • Otsuka Investigational Site
      • Montichiari, Italy, 25018
        • Otsuka Investigational Site
      • Naples, Italy, 80131
        • Otsuka Investigational Site
      • Pavia, Italy, 27100
        • Otsuka Investigational Site
    • Milano
      • Rozzano, Milano, Italy, 20089
        • Otsuka Investigational Site
  • Japan
      • Chiba, Japan, 260-8712
        • Otsuka Investigational Site
      • Fukuoka, Japan, 812-8582
        • Otsuka Investigational Site
      • Hokkaido, Japan, 060-8638
        • Otsuka Investigational Site
      • Niigata, Japan, 951-8520
        • Otsuka Investigational Site
      • Osaka, Japan, 545-8586
        • Otsuka Investigational Site
      • Osaka, Japan, 565-0871
        • Otsuka Investigational Site
      • Tochigi, Japan, 329-0498
        • Otsuka Investigational Site
      • Tokyo, Japan, 113-8510
        • Otsuka Investigational Site
      • Tokyo, Japan, 113-8603
        • Otsuka Investigational Site
      • Tokyo, Japan, 162-8666
        • Otsuka Investigational Site
      • Tokyo, Japan, 173-8606
        • Otsuka Investigational Site
      • Tokyo, Japan, 181-8611
        • Otsuka Investigational Site
    • Kanagawa
      • Sagamihara-shi, Kanagawa, Japan, 252-0375
        • Otsuka Investigational Site
    • Okayama-ken
      • Kurashiki, Okayama-ken, Japan, 701-0192
        • Otsuka Investigational Site
  • Netherlands
      • Groningen, Netherlands, 9700RB
        • Otsuka Investigational Site
      • Leiden, Netherlands, 2333 ZA
        • Otsuka Investigational Site
      • Nijmegen, Netherlands, 6525 GA
        • Otsuka Investigational Site
      • Rotterdam, Netherlands, 3015 CE
        • Otsuka Investigational Site
  • Norway
      • Drammen, Norway, 3004
        • Otsuka Investigational Site
      • Lillehammer, Norway, 2609
        • Otsuka Investigational Site
  • Poland
      • Ciechanów, Poland, 06-400
        • Otsuka Investigational Site
      • Golub-Dobrzyń, Poland, 87-400
        • Otsuka Investigational Site
      • Krakow, Poland, 30-663
        • Otsuka Investigational Site
      • Lodz, Poland, 93-338
        • Otsuka Investigational Site
      • Radom, Poland, 26-610
        • Otsuka Investigational Site
      • Rzeszów, Poland, 35-055
        • Otsuka Investigational Site
      • Szczecin, Poland, 70-111
        • Otsuka Investigational Site
      • Warsaw, Poland, 04-730
        • Otsuka Investigational Site
      • Warsaw, Poland, 04-749
        • Otsuka Investigational Site
      • Wroclaw, Poland, 50-556
        • Otsuka Investigational Site
  • Romania
      • Bucharest, Romania, 010731
        • Otsuka Investigational Site
      • Bucharest, Romania, 022328
        • Otsuka Investigational Site
    • Bihor County
      • Oradea, Bihor County, Romania, 410469
        • Otsuka Investigational Site
    • Timiș County
      • Timișoara, Timiș County, Romania, 300736
        • Otsuka Investigational Site
  • Spain
      • Alicante, Spain, 03010
        • Otsuka Investigational Site
      • Barcelona, Spain, 08036
        • Otsuka Investigational Site
      • Ciudad Real, Spain, 13005
        • Otsuka Investigational Site
      • Hospitalet de Ilobre, Spain, 08907
        • Otsuka Investigational Site
      • Madrid, Spain, 28046
        • Otsuka Investigational Site
  • Sweden
      • Malmo, Sweden, 20502
        • Otsuka Investigational Site
      • Stockholm, Sweden, 14186
        • Otsuka Investigational Site
  • Switzerland
      • Zurich, Switzerland, 8091
        • Otsuka Investigational Site
  • Turkey (Türkiye)
      • Balcali-Adana, Turkey (Türkiye), 1330
        • Otsuka Investigational Site
      • Bornova-Izmir, Turkey (Türkiye), 35100
        • Otsuka Investigational Site
      • Izmir, Turkey (Türkiye), 35100
        • Otsuka Investigational Site
      • Sihhiye-Ankara, Turkey (Türkiye), 6100
        • Otsuka Investigational Site
    • Capa
      • Istanbul, Capa, Turkey (Türkiye), 34390
        • Otsuka Investigational Site
    • İzmir
      • Inciraltı, İzmir, Turkey (Türkiye), 35340
        • Otsuka Investigational Site
  • United Kingdom
      • Belfast, United Kingdom, BT9 7AB
        • Otsuka Investigational Site
      • Bradford, United Kingdom, BD5 0NA
        • Otsuka Investigational Site
      • Bristol, United Kingdom, BS2 8BJ
        • Otsuka Investigational Site
      • Cambridge, United Kingdom, CB2 0QQ
        • Otsuka Investigational Site
      • Chelmsford, United Kingdom, CM1 7ET
        • Otsuka Investigational Site
      • Coventry, United Kingdom, CV2 2DX
        • Otsuka Investigational Site
      • Dorchester, United Kingdom, DT1 2JY
        • Otsuka Investigational Site
      • Edinburgh, United Kingdom, EH16 4SA
        • Otsuka Investigational Site
      • Hull, United Kingdom, HU3 2JZ
        • Otsuka Investigational Site
      • Inverness, United Kingdom, IV2 3UJ
        • Otsuka Investigational Site
      • Kirkcaldy, United Kingdom, KY2 5AH
        • Otsuka Investigational Site
      • Leicester, United Kingdom, LE5 4PW
        • Otsuka Investigational Site
      • Liverpool, United Kingdom, L7 8XP
        • Otsuka Investigational Site
      • London, United Kingdom, NW3 2QG
        • Otsuka Investigational Site
      • London, United Kingdom, SW17 0QT
        • Otsuka Investigational Site
      • London, United Kingdom, WC1N 3JH
        • Otsuka Investigational Site
      • Manchester, United Kingdom, M13 9WL
        • Otsuka Investigational Site
      • Middlesbrough, United Kingdom, TS4 3BW
        • Otsuka Investigational Site
      • Newcastle upon Tyne, United Kingdom, NE7 7DN
        • Otsuka Investigational Site
      • Oxford, United Kingdom, OX3 7LJ
        • Otsuka Investigational Site
      • Portsmouth, United Kingdom, PO6 3LY
        • Otsuka Investigational Site
      • Preston, United Kingdom, PR2 9HT
        • Otsuka Investigational Site
      • Salford, United Kingdom, M6 8HD
        • Otsuka Investigational Site
      • Sheffield, United Kingdom, S5 7AU
        • Otsuka Investigational Site
      • Southampton, United Kingdom, SO16 6YD
        • Otsuka Investigational Site
      • Stevenage, United Kingdom, SG1 4AB
        • Otsuka Investigational Site
      • Westcliff-on-Sea, United Kingdom, SS0 0RY
        • Otsuka Investigational Site
      • Wolverhampton, United Kingdom, WV10 0QP
        • Otsuka Investigational Site
    • Devon
      • Exeter, Devon, United Kingdom, EX2 5DW
        • Otsuka Investigational Site
    • North Yorkshire
      • York, North Yorkshire, United Kingdom, YO31 8HE
        • Otsuka Investigational Site
    • Staffordshire
      • Stoke-on-Trent, Staffordshire, United Kingdom, ST4 6QG
        • Otsuka Investigational Site
    • Surrey
      • Carshalton, Surrey, United Kingdom, SM5 1AA
        • Otsuka Investigational Site
    • West Midlands
      • Birmingham, West Midlands, United Kingdom, B4 6NH
        • Otsuka Investigational Site
  • United States
    • Arizona
      • Peoria, Arizona, United States, 85381
        • Otsuka Investigational Site 1
      • Peoria, Arizona, United States, 85381
        • Otsuka Investigational Site 2
      • Tempe, Arizona, United States, 85284
        • Otsuka Investigational Site
    • California
      • Azusa, California, United States, 91702
        • Otsuka Investigational Site
      • Bakersfield, California, United States, 93308
        • Otsuka Investigational Site
      • Los Angeles, California, United States, 90025
        • Otsuka Investigational Site
      • Los Angeles, California, United States, 90022
        • Otsuka Investigational Site
      • Ontario, California, United States, 91762
        • Otsuka Investigational Site
      • San Diego, California, United States, 92108
        • Otsuka Investigational Site
    • Colorado
      • Arvada, Colorado, United States, 80002
        • Otsuka Investigational Site
      • Aurora, Colorado, United States, 80045
        • Otsuka Investigational Site
      • Denver, Colorado, United States, 80210
        • Otsuka Investigational Site
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Otsuka Investigational Site
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20037
        • Otsuka Investigational Site
    • Florida
      • Coral Gables, Florida, United States, 33146
        • Otsuka Investigational Site
      • Hudson, Florida, United States, 34667
        • Otsuka Investigational Site
      • Jacksonville, Florida, United States, 32216
        • Otsuka Investigational Site
      • Melbourne, Florida, United States, 32935
        • Otsuka Investigational Site
      • Port Charlotte, Florida, United States, 33952
        • Otsuka Investigational Site
      • Tampa, Florida, United States, 33614
        • Otsuka Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Otsuka Investigational Site
      • Augusta, Georgia, United States, 30901
        • Otsuka Investigational Site
    • Idaho
      • Meridian, Idaho, United States, 83642
        • Otsuka Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Otsuka Investigational Site
      • Peoria, Illinois, United States, 61602
        • Otsuka Investigational Site
    • Indiana
      • Mishawaka, Indiana, United States, 46545
        • Otsuka Investigational Site
    • Kansas
      • Kansas City, Kansas, United States, 66106
        • Otsuka Investigational Site
      • Wichita, Kansas, United States, 67214
        • Otsuka Investigational Site
    • Kentucky
      • Lexington, Kentucky, United States, 40513
        • Otsuka Investigational Site
      • Paducah, Kentucky, United States, 42003
        • Otsuka Investigational Site
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Otsuka Investigational Site
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Otsuka Investigational Site
      • Baltimore, Maryland, United States, 21201
        • Otsuka Investigational Site
      • Bethesda, Maryland, United States, 20814
        • Otsuka Investigational Site
      • Rockville, Maryland, United States, 20850
        • Otsuka Investigational Site
      • Rockville, Maryland, United States, 20852
        • Otsuka Investigational Site
      • Wheaton, Maryland, United States, 20906
        • Otsuka Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Otsuka Investigational Site
      • Boston, Massachusetts, United States, 02215
        • Otsuka Investigational Site
      • Holyoke, Massachusetts, United States, 01040
        • Otuska Investigational Site
      • Plymouth, Massachusetts, United States, 02360
        • Otsuka Investigational Site
      • Springfield, Massachusetts, United States, 01107
        • Otsuka Investigational Site
    • Michigan
      • Detroit, Michigan, United States, 48236
        • Otsuka Investigational Site
      • Kalamazoo, Michigan, United States, 49007
        • Otsuka Investigational Site
      • Pontiac, Michigan, United States, 48341
        • Otsuka Investigational Site
      • Royal Oak, Michigan, United States, 48073
        • Otsuka Investigational Site
    • Minnesota
      • Brooklyn Center, Minnesota, United States, 55430
        • Otsuka Investigational Site
      • Rochester, Minnesota, United States, 55905
        • Otsuka Investigational Site
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Otsuka Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • Otsuka Investigational Site
      • Las Vegas, Nevada, United States, 89115
        • Otsuka Investigational Site
      • Reno, Nevada, United States, 89511
        • Otsuka Investigational Site
    • New Jersey
      • Mount Laurel, New Jersey, United States, 08054
        • Otsuka Investigational Site
      • Princeton Junction, New Jersey, United States, 08550
        • Otsuka Investigational Site
      • Voorhees Township, New Jersey, United States, 08043
        • Otsuka Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • Otsuka Investigational Site
    • New York
      • Albany, New York, United States, 12208
        • Otsuka Investigational Site
      • Brooklyn, New York, United States, 11215
        • Otsuka Investigational Site
      • Buffalo, New York, United States, 14215
        • Otsuka Investigational Site
      • Flushing, New York, United States, 11355
        • Otsuka Investigational Site
      • Forest Hills, New York, United States, 11375
        • Otsuka Investigational Site
      • Great Neck, New York, United States, 11021
        • Otsuka Investigational Site
      • Mineola, New York, United States, 11501
        • Otsuka Investigational Site
      • New York, New York, United States, 10016
        • Otsuka Investigational Site
      • New York, New York, United States, 10021
        • Otsuka Investigational Site
      • New York, New York, United States, 10033
        • Otsuka Investigational Site
      • Port Washington, New York, United States, 11050
        • Otsuka Investigational Site
      • Rochester, New York, United States, 14642
        • Otsuka Investigational Site
      • Rosedale, New York, United States, 11422
        • Otsuka Investigational Site
      • The Bronx, New York, United States, 10467
        • Otsuka Investigational Site
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Otsuka Investigational Site
      • Durham, North Carolina, United States, 27705
        • Otsuka Investigational Site
      • Winston-Salem, North Carolina, United States, 27103
        • Otsuka Investigational Site
    • North Dakota
      • Devils Lake, North Dakota, United States, 58301
        • Otsuka Investigational Site
      • Fargo, North Dakota, United States, 58122
        • Otsuka Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • Otsuka Investigational Site
      • Cleveland, Ohio, United States, 44106
        • Otsuka Investigational Site
      • Columbus, Ohio, United States, 43210
        • Otsuka Investigational Site
    • Oregon
      • Portland, Oregon, United States, 97210
        • Otsuka Investigational Site
    • Pennsylvania
      • Altoona, Pennsylvania, United States, 16601
        • Otsuka Investigational Site
      • Bethlehem, Pennsylvania, United States, 18017
        • Otsuka Investigational Site
      • Doylestown, Pennsylvania, United States, 18901
        • Otsuka Investigational Site
      • Lancaster, Pennsylvania, United States, 17604
        • Otsuka Investigational Site
      • Philadelphia, Pennsylvania, United States, 19104
        • Otsuka Investigational Site
    • Rhode Island
      • Providence, Rhode Island, United States, 02904
        • Otsuka Investigational Site
    • South Carolina
      • Aiken, South Carolina, United States, 29801
        • Otsuka Investigational Site
      • Anderson, South Carolina, United States, 29621
        • Otsuka Investigational Site
      • Columbia, South Carolina, United States, 29203
        • Otsuka Investigational Site
      • Columbia, South Carolina, United States, 29209
        • Otsuka Investigational Site
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Otsuka Investigational Site
    • Tennessee
      • Knoxville, Tennessee, United States, 37923
        • Otsuka Investigational Site
    • Texas
      • Arlington, Texas, United States, 76015
        • Otsuka Investigational Site
      • Fort Worth, Texas, United States, 76104
        • Otsuka Investigational Site
      • Houston, Texas, United States, 77004
        • Otsuka Investigational Site
      • Houston, Texas, United States, 77030
        • Otsuka Investigational Site
      • Mission, Texas, United States, 78572
        • Otsuka Investigational Site
      • San Antonio, Texas, United States, 78215
        • Otsuka Investigational Site
    • Vermont
      • Burlington, Vermont, United States, 05401
        • Otsuka Investigational Site
    • Virginia
      • Fairfax, Virginia, United States, 22030
        • Otsuka Investigational Site
    • West Virginia
      • Bluefield, West Virginia, United States, 24701
        • Otsuka Investigational Site
      • Morgantown, West Virginia, United States, 26506
        • Otsuka Investigational Site
    • Wisconsin
      • Madison, Wisconsin, United States, 53713
        • Otsuka Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

12 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Subjects will be identified by participating clinics (primarily nephrology clinics) treating patients with ADPKD.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
No treatment

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Correlation of change in total kidney volume with ADPKD-related outcomes
Time Frame: 1 year
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Patient-reported pain
Time Frame: every 6 months
every 6 months
SF-12 Scores
Time Frame: every 6 months
every 6 months
ADPKD-Impact Scale Score
Time Frame: every 6 months
every 6 months
Cost of care
Time Frame: every 6 months
every 6 months
EQ-5D Scores
Time Frame: Every 6 months
Every 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Otsuka Pharmaceutical Development & Commercialization, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Otsuka Pharmaceutical Co., Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 29, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 6, 2011

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 8, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 28, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 156-10-291

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings