CClinicalTrials.gg
CompletedNCT01430494OVERTUREUpdated Apr 28, 2026

Observational Study in Patients With Autosomal Dominant Polycystic Kidney Disease

An observational study in Autosomal Dominant Polycystic Kidney Disease (ADPKD), sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc.. Completed at 266 sites in 20 countries. Open to participants aged 12 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-04-28.

Sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc. · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
3,409
Ages
12 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Autosomal Dominant Polycystic Kidney Disease (ADPKD)
03

In context

Polycystic Kidney, Autosomal Dominant

173 studies on the registry are indexed under Polycystic Kidney, Autosomal Dominant; 37 are open to participants now.

This study's enrollment of 3,409 is above the median of 150 across 43 observational studies indexed under Polycystic Kidney, Autosomal Dominant.

Browse Polycystic Kidney, Autosomal Dominant studies →

Lead sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc. is the lead sponsor of 289 studies on the registry; 18 are open to participants now.

Of its 104 completed or terminated interventional studies of FDA-regulated products, 69 (66%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 70 Years
Sexes eligible
All
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.

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

Exclusion Criteria:

  • Current or expected (within the next six months) interventions for the treatment of ADPKD affecting kidney volume
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
3,409 participants (actual)
Patient registry
No

Groups and cohorts

  • No treatment
06

What researchers measure

Primary outcomes

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

    Time frame: 1 year

Secondary outcomes

  1. Patient-reported pain

    Time frame: every 6 months

  2. SF-12 Scores

    Time frame: every 6 months

  3. ADPKD-Impact Scale Score

    Time frame: every 6 months

  4. Cost of care

    Time frame: every 6 months

  5. EQ-5D Scores

    Time frame: Every 6 months

07

Study locations

266 sites
  • 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
  • Otsuka Investigational Site
    Kansas City, Kansas 66106, United States
  • Otsuka Investigational Site
    Wichita, Kansas 67214, United States
  • Otsuka Investigational Site
    Lexington, Kentucky 40513, United States
  • Otsuka Investigational Site
    Paducah, Kentucky 42003, United States
  • Otsuka Investigational Site
    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
  • Otsuka Investigational Site
    Rockville, Maryland 20850, United States
  • Otsuka Investigational Site
    Rockville, Maryland 20852, United States
  • Otsuka Investigational Site
    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
  • Otsuka Investigational Site
    Pontiac, Michigan 48341, United States
  • Otsuka Investigational Site
    Royal Oak, Michigan 48073, United States
  • Otsuka Investigational Site
    Brooklyn Center, Minnesota 55430, United States
  • Otsuka Investigational Site
    Rochester, Minnesota 55905, United States
  • Otsuka Investigational Site
    St Louis, Missouri 63110, United States
  • Otsuka Investigational Site
    Las Vegas, Nevada 89106, United States
  • Otsuka Investigational Site
    Las Vegas, Nevada 89115, United States
  • Otsuka Investigational Site
    Reno, Nevada 89511, United States
  • Otsuka Investigational Site
    Mount Laurel, New Jersey 08054, United States
  • Otsuka Investigational Site
    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
  • Otsuka Investigational Site
    Buffalo, New York 14215, United States
  • Otsuka Investigational Site
    Flushing, New York 11355, United States
  • Otsuka Investigational Site
    Forest Hills, New York 11375, United States
  • Otsuka Investigational Site
    Great Neck, New York 11021, United States
  • Otsuka Investigational Site
    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
  • Otsuka Investigational Site
    The Bronx, New York 10467, United States
  • Otsuka Investigational Site
    Chapel Hill, North Carolina 27599, United States
  • Otsuka Investigational Site
    Durham, North Carolina 27705, United States
  • Otsuka Investigational Site
    Winston-Salem, North Carolina 27103, United States
  • Otsuka Investigational Site
    Devils Lake, North Dakota 58301, United States
  • Otsuka Investigational Site
    Fargo, North Dakota 58122, United States
  • Otsuka Investigational Site
    Cincinnati, Ohio 45267, United States
  • Otsuka Investigational Site
    Cleveland, Ohio 44106, United States
  • Otsuka Investigational Site
    Columbus, Ohio 43210, United States
  • Otsuka Investigational Site
    Portland, Oregon 97210, United States
  • Otsuka Investigational Site
    Altoona, Pennsylvania 16601, United States
  • Otsuka Investigational Site
    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
  • Otsuka Investigational Site
    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

Showing the first 100 of 266 sites across 20 countries.

08

References and documents

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 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01430494
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators
Otsuka Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Sep 8, 2011
Start date
Jun 1, 2011
Primary completion
Oct 1, 2014
Completion
Oct 1, 2014
Last update
Apr 28, 2026

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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