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Autosomal Dominant Polycystic Kidney Disease (ADPKD)OVERTURENCT01430494

Observational Study in Patients With Autosomal Dominant Polycystic Kidney Disease

An observational study of Autosomal Dominant Polycystic Kidney Disease (ADPKD), run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 266 sites in 20 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 12 to 70 years
How many people
3,409 participants
Where
266 sitesin 20 countries
Study dates
1 Jun 2011to 1 Oct 2014
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 70 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Who may be able to join

  • existing diagnosis of ADPKD by modified-Ravine criteria
  • Total kidney volume >= 300 cc/m height by ultrasound or >= 250 cc/m height by MRI

Who cannot join

  • Current or expected (within the next six months) interventions for the treatment of ADPKD affecting kidney volume

Trial locations and contacts

266 sites in 20 countries.

266 sites in 20 countries

United States102 sites

  • Otsuka Investigational Site

    Aiken, South Carolina, 29801

  • Otsuka Investigational Site

    Albany, New York, 12208

  • Otsuka Investigational Site

    Albuquerque, New Mexico, 87109

  • Otsuka Investigational Site

    Altoona, Pennsylvania, 16601

  • Otsuka Investigational Site

    Anderson, South Carolina, 29621

  • Otsuka Investigational Site

    Arlington, Texas, 76015

  • Otsuka Investigational Site

    Arvada, Colorado, 80002

  • Otsuka Investigational Site

    Atlanta, Georgia, 30322

  • Otsuka Investigational Site

    Augusta, Georgia, 30901

  • Otsuka Investigational Site

    Aurora, Colorado, 80045

  • Otsuka Investigational Site

    Azusa, California, 91702

  • Otsuka Investigational Site

    Bakersfield, California, 93308

  • Otsuka Investigational Site

    Baltimore, Maryland, 21201

  • Otsuka Investigational Site

    Baltimore, Maryland, 21224

  • Otsuka Investigational Site

    Bethesda, Maryland, 20814

  • Otsuka Investigational Site

    Bethlehem, Pennsylvania, 18017

  • Otsuka Investigational Site

    Bluefield, West Virginia, 24701

  • Otsuka Investigational Site

    Boston, Massachusetts, 02111

  • Otsuka Investigational Site

    Boston, Massachusetts, 02215

  • Otsuka Investigational Site

    Brooklyn, New York, 11215

  • Otsuka Investigational Site

    Brooklyn Center, Minnesota, 55430

  • Otsuka Investigational Site

    Buffalo, New York, 14215

  • Otsuka Investigational Site

    Burlington, Vermont, 05401

  • Otsuka Investigational Site

    Chapel Hill, North Carolina, 27599

  • Otsuka Investigational Site

    Chicago, Illinois, 60637

  • Otsuka Investigational Site

    Cincinnati, Ohio, 45267

  • Otsuka Investigational Site

    Cleveland, Ohio, 44106

  • Otsuka Investigational Site

    Columbia, South Carolina, 29203

  • Otsuka Investigational Site

    Columbia, South Carolina, 29209

  • Otsuka Investigational Site

    Columbus, Ohio, 43210

  • Otsuka Investigational Site

    Coral Gables, Florida, 33146

  • Otsuka Investigational Site

    Denver, Colorado, 80210

  • Otsuka Investigational Site

    Detroit, Michigan, 48236

  • Otsuka Investigational Site

    Devils Lake, North Dakota, 58301

  • Otsuka Investigational Site

    Doylestown, Pennsylvania, 18901

  • Otsuka Investigational Site

    Durham, North Carolina, 27705

  • Otsuka Investigational Site

    Fairfax, Virginia, 22030

  • Otsuka Investigational Site

    Fargo, North Dakota, 58122

  • Otsuka Investigational Site

    Flushing, New York, 11355

  • Otsuka Investigational Site

    Forest Hills, New York, 11375

  • Otsuka Investigational Site

    Fort Worth, Texas, 76104

  • Otsuka Investigational Site

    Great Neck, New York, 11021

  • Otuska Investigational Site

    Holyoke, Massachusetts, 01040

  • Otsuka Investigational Site

    Houston, Texas, 77004

  • Otsuka Investigational Site

    Houston, Texas, 77030

  • Otsuka Investigational Site

    Hudson, Florida, 34667

  • Otsuka Investigational Site

    Jacksonville, Florida, 32216

  • Otsuka Investigational Site

    Kalamazoo, Michigan, 49007

  • Otsuka Investigational Site

    Kansas City, Kansas, 66106

  • Otsuka Investigational Site

    Knoxville, Tennessee, 37923

  • Otsuka Investigational Site

    Lancaster, Pennsylvania, 17604

  • Otsuka Investigational Site

    Las Vegas, Nevada, 89106

  • Otsuka Investigational Site

    Las Vegas, Nevada, 89115

  • Otsuka Investigational Site

    Lexington, Kentucky, 40513

  • Otsuka Investigational Site

    Los Angeles, California, 90022

  • Otsuka Investigational Site

    Los Angeles, California, 90025

  • Otsuka Investigational Site

    Madison, Wisconsin, 53713

  • Otsuka Investigational Site

    Melbourne, Florida, 32935

  • Otsuka Investigational Site

    Meridian, Idaho, 83642

  • Otsuka Investigational Site

    Mineola, New York, 11501

  • Otsuka Investigational Site

    Mishawaka, Indiana, 46545

  • Otsuka Investigational Site

    Mission, Texas, 78572

  • Otsuka Investigational Site

    Morgantown, West Virginia, 26506

  • Otsuka Investigational Site

    Mount Laurel, New Jersey, 08054

  • Otsuka Investigational Site

    New Haven, Connecticut, 06510

  • Otsuka Investigational Site

    New Orleans, Louisiana, 70121

  • Otsuka Investigational Site

    New York, New York, 10016

  • Otsuka Investigational Site

    New York, New York, 10021

  • Otsuka Investigational Site

    New York, New York, 10033

  • Otsuka Investigational Site

    Ontario, California, 91762

  • Otsuka Investigational Site

    Paducah, Kentucky, 42003

  • Otsuka Investigational Site 1

    Peoria, Arizona, 85381

  • Otsuka Investigational Site 2

    Peoria, Arizona, 85381

  • Otsuka Investigational Site

    Peoria, Illinois, 61602

  • Otsuka Investigational Site

    Philadelphia, Pennsylvania, 19104

  • Otsuka Investigational Site

    Plymouth, Massachusetts, 02360

  • Otsuka Investigational Site

    Pontiac, Michigan, 48341

  • Otsuka Investigational Site

    Port Charlotte, Florida, 33952

  • Otsuka Investigational Site

    Port Washington, New York, 11050

  • Otsuka Investigational Site

    Portland, Oregon, 97210

  • Otsuka Investigational Site

    Princeton Junction, New Jersey, 08550

  • Otsuka Investigational Site

    Providence, Rhode Island, 02904

  • Otsuka Investigational Site

    Rapid City, South Dakota, 57701

  • Otsuka Investigational Site

    Reno, Nevada, 89511

  • Otsuka Investigational Site

    Rochester, Minnesota, 55905

  • Otsuka Investigational Site

    Rochester, New York, 14642

  • Otsuka Investigational Site

    Rockville, Maryland, 20850

  • Otsuka Investigational Site

    Rockville, Maryland, 20852

  • Otsuka Investigational Site

    Rosedale, New York, 11422

  • Otsuka Investigational Site

    Royal Oak, Michigan, 48073

  • Otsuka Investigational Site

    San Antonio, Texas, 78215

  • Otsuka Investigational Site

    San Diego, California, 92108

  • Otsuka Investigational Site

    Springfield, Massachusetts, 01107

  • Otsuka Investigational Site

    St Louis, Missouri, 63110

  • Otsuka Investigational Site

    Tampa, Florida, 33614

  • Otsuka Investigational Site

    Tempe, Arizona, 85284

  • Otsuka Investigational Site

    The Bronx, New York, 10467

  • Otsuka Investigational Site

    Voorhees Township, New Jersey, 08043

  • Otsuka Investigational Site

    Washington D.C., District of Columbia, 20037

  • Otsuka Investigational Site

    Wheaton, Maryland, 20906

  • Otsuka Investigational Site

    Wichita, Kansas, 67214

  • Otsuka Investigational Site

    Winston-Salem, North Carolina, 27103

Other trials in United States

United Kingdom33 sites

  • Otsuka Investigational Site

    Belfast, BT9 7AB

  • Otsuka Investigational Site

    Birmingham, West Midlands, B4 6NH

  • Otsuka Investigational Site

    Bradford, BD5 0NA

  • Otsuka Investigational Site

    Bristol, BS2 8BJ

  • Otsuka Investigational Site

    Cambridge, CB2 0QQ

  • Otsuka Investigational Site

    Carshalton, Surrey, SM5 1AA

  • Otsuka Investigational Site

    Chelmsford, CM1 7ET

  • Otsuka Investigational Site

    Coventry, CV2 2DX

  • Otsuka Investigational Site

    Dorchester, DT1 2JY

  • Otsuka Investigational Site

    Edinburgh, EH16 4SA

  • Otsuka Investigational Site

    Exeter, Devon, EX2 5DW

  • Otsuka Investigational Site

    Hull, HU3 2JZ

  • Otsuka Investigational Site

    Inverness, IV2 3UJ

  • Otsuka Investigational Site

    Kirkcaldy, KY2 5AH

  • Otsuka Investigational Site

    Leicester, LE5 4PW

  • Otsuka Investigational Site

    Liverpool, L7 8XP

  • Otsuka Investigational Site

    London, NW3 2QG

  • Otsuka Investigational Site

    London, SW17 0QT

  • Otsuka Investigational Site

    London, WC1N 3JH

  • Otsuka Investigational Site

    Manchester, M13 9WL

  • Otsuka Investigational Site

    Middlesbrough, TS4 3BW

  • Otsuka Investigational Site

    Newcastle upon Tyne, NE7 7DN

  • Otsuka Investigational Site

    Oxford, OX3 7LJ

  • Otsuka Investigational Site

    Portsmouth, PO6 3LY

  • Otsuka Investigational Site

    Preston, PR2 9HT

  • Otsuka Investigational Site

    Salford, M6 8HD

  • Otsuka Investigational Site

    Sheffield, S5 7AU

  • Otsuka Investigational Site

    Southampton, SO16 6YD

  • Otsuka Investigational Site

    Stevenage, SG1 4AB

  • Otsuka Investigational Site

    Stoke-on-Trent, Staffordshire, ST4 6QG

  • Otsuka Investigational Site

    Westcliff-on-Sea, SS0 0RY

  • Otsuka Investigational Site

    Wolverhampton, WV10 0QP

  • Otsuka Investigational Site

    York, North Yorkshire, YO31 8HE

Other trials in United Kingdom

Canada15 sites

  • Otsuka Investigational Site

    Brampton, Ontario, L6Z 4N5

  • Otsuka Investigational Site

    Edmonton, Ontario, T6G2B7

  • Otsuka Investigational Site

    Greenfield Park, Quebec, J4V 2H1

  • Otsuka Investigational Site

    Halifax, Nova Scotia, B3H 1V7

  • Otsuka Investigational Site

    Montreal, Quebec, H3A 1A1

  • Otsuka Investigational Site

    Montreal, Quebec, H3G 1A4

  • Otsuka Investigational Site

    Montreal, Quebec, H4J 1C5

  • Otsuka Investigational Site

    Oakville, Ontario, L6J 3M5

  • Otsuka Investigational Site

    Scarborough Village, Ontario, M1H 3G4

  • Otsuka Investigational Site

    St. John's, Newfoundland and Labrador, A1B 3V6

  • Otsuka Investigational Site

    Toronto, Ontario, M4C 5T2

  • Otsuka Investigational Site

    Toronto, Ontario, M5B 1W8

  • Otsuka Investigational Site

    Toronto, Ontario, M5G 2N2

  • Otsuka Investigational Site

    Vancouver, British Columbia, V5Z 1M9

  • Otsuka Investigational Site

    Vancouver, British Columbia, V6Z 1Y2

Other trials in Canada

Australia14 sites

  • Otsuka Investigational Site

    Adelaide, South Australia, 5000

  • Otsuka Investigational Site

    Clayton, Victoria, 3168

  • Otsuka Investigational Site

    Launceston, Tasmania, 7250

  • Otsuka Investigational Site

    Liverpool, New South Wales, 2170

  • Otsuka Investigational Site

    Melbourne, Victoria, 3073

  • Otsuka Investigational Site

    Newcastle, New South Wales, 2305

  • Otsuka Investigational Site

    Parkville, Victoria, 3050

  • Otsuka Investigational Site

    Perth, Western Australia, 6000

  • Otsuka Investigational Site

    Richmond, Victoria, 3121

  • Otsuka Investigational Site

    Sydney, New South Wales, 2031

  • Otsuka Investigational Site

    Sydney, New South Wales, 2050

  • Otsuka Investigational Site

    Sydney, New South Wales, 2065

  • Otsuka Investigational Site

    Sydney, New South Wales, 2139

  • Otsuka Investigational Site

    Westmead, New South Wales, 2145

Other trials in Australia

Japan14 sites

  • Otsuka Investigational Site

    Chiba, 260-8712

  • Otsuka Investigational Site

    Fukuoka, 812-8582

  • Otsuka Investigational Site

    Hokkaido, 060-8638

  • Otsuka Investigational Site

    Kurashiki, Okayama-ken, 701-0192

  • Otsuka Investigational Site

    Niigata, 951-8520

  • Otsuka Investigational Site

    Osaka, 545-8586

  • Otsuka Investigational Site

    Osaka, 565-0871

  • Otsuka Investigational Site

    Sagamihara-shi, Kanagawa, 252-0375

  • Otsuka Investigational Site

    Tochigi, 329-0498

  • Otsuka Investigational Site

    Tokyo, 113-8510

  • Otsuka Investigational Site

    Tokyo, 113-8603

  • Otsuka Investigational Site

    Tokyo, 162-8666

  • Otsuka Investigational Site

    Tokyo, 173-8606

  • Otsuka Investigational Site

    Tokyo, 181-8611

Other trials in Japan

Argentina13 sites

  • Otsuka Investigational Site

    Avellaneda, Buenos Aires, 1872

  • Otsuka Investigational Site

    Buenos Aires, C.a.b.a., C1429BWN

  • Otsuka Investigational Site

    Buenos Aires, C1181ACH

  • Otsuka Investigational Site

    Buenos Aires, C1425APQ

  • Otsuka Investigational Site

    Ciudad de Buenos Aires, C1155AHD

  • Otsuka Investigational Site

    Ciudad de Buenos Aires, C1431FWO

  • Otsuka Investigational Site

    Córdoba, X5002HWE

  • Otsuka Investigational Site

    Córdoba, X5016KEH

  • Otsuka Investigational Site

    Junín, Buenos Aires, 6000

  • Otsuka Investigational Site

    La Plata, Buenos Aires, B1902AWL

  • Otsuka Investigational Sites

    Pergamino, Buenos Aires, 2700

  • Otsuka Investigational Site

    Pilar, Buenos Aires, B16260DT

  • Otsuka Investigational Site

    Sante Fe, 3000

Other trials in Argentina

Brazil11 sites

  • Otsuka Investigational Site

    Belo Horizonte, Minas Gerais, 30180-060

  • Otsuka Investigational Site

    Curitiba, Paraná, 80440-020

  • Otsuka Investigational Site

    Joinville, Santa Catarina, 89227-680

  • Otsuka Investigational Site

    Juiz de Fora, Minas Gerais, 36036-330

  • Otsuka Investigational Site

    Porto Alegre, Rio Grande do Sul, 90020-090

  • Otsuka Investigational Site

    Porto Alegre, Rio Grande do Sul, 90035-003

  • Otsuka Investigational Site

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Otsuka Investigational Site

    São José do Rio Preto, São Paulo, 15015-200

  • Otsuka Investigational Site

    São Paulo, São Paulo, 01246-903

  • Otsuka Investigational Site

    São Paulo, São Paulo, 01323-001

  • Otsuka Investigational Site

    São Paulo, 04038-002

Other trials in Brazil

Poland10 sites

  • Otsuka Investigational Site

    Ciechanów, 06-400

  • Otsuka Investigational Site

    Golub-Dobrzyń, 87-400

  • Otsuka Investigational Site

    Krakow, 30-663

  • Otsuka Investigational Site

    Lodz, 93-338

  • Otsuka Investigational Site

    Radom, 26-610

  • Otsuka Investigational Site

    Rzeszów, 35-055

  • Otsuka Investigational Site

    Szczecin, 70-111

  • Otsuka Investigational Site

    Warsaw, 04-730

  • Otsuka Investigational Site

    Warsaw, 04-749

  • Otsuka Investigational Site

    Wroclaw, 50-556

Other trials in Poland

Germany8 sites

  • Otsuka Investigational Site

    Berlin, 10117

  • Otsuka Investigational Site

    Dresden, 01307

  • Otsuka Investigational Site

    Düsseldorf, 40210

  • Otsuka Investigational Site

    Erlangen, 91054

  • Otsuka Investigational Site

    Hanover, 30625

  • Otsuka Investigational Site

    Heidelberg, 69120

  • Otsuka Investigational Site

    Munich, 81675

  • Otsuka Investigational Site

    Wiesbaden, 65191

Other trials in Germany

France7 sites

  • Otsuka Investigational Site

    Caen, 14033

  • Otsuka Investigational Site

    Grenoble, 38043

  • Otuska Investigational Site

    Lyon, 69437

  • Otsuka Investigational Site

    Lyon, 69473

  • Otsuka Investigational Site

    Montpellier, 34295

  • Otsuka Investigational Site

    Pierre-Bénite, 69495

  • Otsuka Investigational Site

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Italy7 sites

  • Otsuka Investigational Site

    Bologna, 40138

  • Otsuka Investigational Site

    Lecco, 23900

  • Otsuka Investigational Site

    Modena, 41100

  • Otsuka Investigational Site

    Montichiari, 25018

  • Otsuka Investigational Site

    Naples, 80131

  • Otsuka Investigational Site

    Pavia, 27100

  • Otsuka Investigational Site

    Rozzano, Milano, 20089

Other trials in Italy

Turkey (Türkiye)6 sites

  • Otsuka Investigational Site

    Balcali-Adana, 1330

  • Otsuka Investigational Site

    Bornova-Izmir, 35100

  • Otsuka Investigational Site

    Inciraltı, İzmir, 35340

  • Otsuka Investigational Site

    Istanbul, Capa, 34390

  • Otsuka Investigational Site

    Izmir, 35100

  • Otsuka Investigational Site

    Sihhiye-Ankara, 6100

Other trials in Turkey (Türkiye)

Czechia5 sites

  • Otsuka Investigational Site

    České Budějovice, 370 01

  • Otsuka Investigational Site

    Hradec Králové, 500 05

  • Otsuka Investigational Site

    Jihlava, 586 33

  • Otsuka Investigational Site

    Liberec, 460 63

  • Otsuka Investigational Site

    Prague, 128 08

Other trials in Czechia

Spain5 sites

  • Otsuka Investigational Site

    Alicante, 03010

  • Otsuka Investigational Site

    Barcelona, 08036

  • Otsuka Investigational Site

    Ciudad Real, 13005

  • Otsuka Investigational Site

    Hospitalet de Ilobre, 08907

  • Otsuka Investigational Site

    Madrid, 28046

Other trials in Spain

Netherlands4 sites

  • Otsuka Investigational Site

    Groningen, 9700RB

  • Otsuka Investigational Site

    Leiden, 2333 ZA

  • Otsuka Investigational Site

    Nijmegen, 6525 GA

  • Otsuka Investigational Site

    Rotterdam, 3015 CE

Other trials in Netherlands

Romania4 sites

  • Otsuka Investigational Site

    Bucharest, 010731

  • Otsuka Investigational Site

    Bucharest, 022328

  • Otsuka Investigational Site

    Oradea, Bihor County, 410469

  • Otsuka Investigational Site

    Timișoara, Timiș County, 300736

Other trials in Romania

Belgium3 sites

  • Otsuka Investigational Site

    Brussels, 1200

  • Otsuka Investigational Site

    Ghent, 9000

  • Otsuka Investigational Site

    Leuven, 3000

Other trials in Belgium

Norway2 sites

  • Otsuka Investigational Site

    Drammen, 3004

  • Otsuka Investigational Site

    Lillehammer, 2609

Other trials in Norway

Sweden2 sites

  • Otsuka Investigational Site

    Malmö, 20502

  • Otsuka Investigational Site

    Stockholm, 14186

Other trials in Sweden

Switzerland1 site

  • Otsuka Investigational Site

    Zurich, 8091

Other trials in Switzerland

About this study

Official 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.

Medical subject headings
Polycystic Kidney, Autosomal Dominant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01430494
Study groupRoleWhat they receive
No treatmentNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Correlation of change in total kidney volume with ADPKD-related outcomes

    Measured: 1 year

Secondary outcomes (5)

  1. Patient-reported pain

    Measured: every 6 months

  2. SF-12 Scores

    Measured: every 6 months

  3. ADPKD-Impact Scale Score

    Measured: every 6 months

  4. Cost of care

    Measured: every 6 months

  5. EQ-5D Scores

    Measured: Every 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Sep 2011 (estimated)
  2. Study start1 Jun 2011
  3. Primary completion1 Oct 2014
  4. Study completion1 Oct 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
3,409 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01430494
Sponsor's protocol ID
156-10-291
Acronym
OVERTURE
Status last verified
Apr 2026
First submitted
29 Jul 2011
Last updated
28 Apr 2026
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 39752236

  • 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.

    PubMed 37349694

  • 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.

    PubMed 37250503

  • 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.

    PubMed 37180499

Questions about this trial

What is this clinical trial studying?

An observational study of Autosomal Dominant Polycystic Kidney Disease (ADPKD), run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 266 sites in 20 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 266 sites in United States, United Kingdom, Canada, Australia, Japan and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Correlation of change in total kidney volume with ADPKD-related outcomes (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01430494, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.

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