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

This study has been completed.
Otsuka Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc. Identifier:
First received: July 29, 2011
Last updated: April 22, 2015
Last verified: April 2015
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.

Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:

Further study details as provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:

Primary Outcome Measures:
  • Correlation of change in total kidney volume with ADPKD-related outcomes [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • Patient-reported pain [ Time Frame: every 6 months ]
  • SF-12 Scores [ Time Frame: every 6 months ]
  • ADPKD-Impact Scale Score [ Time Frame: every 6 months ]
  • Cost of care [ Time Frame: every 6 months ]
  • EQ-5D Scores [ Time Frame: Every 6 months ]

Enrollment: 3409
Study Start Date: June 2011
Study Completion Date: October 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
No treatment


Ages Eligible for Study:   12 Years to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   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:

  • Current or expected (within the next six months) interventions for the treatment of ADPKD affecting kidney volume
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01430494

  Show 266 Study Locations
Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
Otsuka Pharmaceutical Co., Ltd.
Study Director: Frank Czerwiec, MD, PhD Otsuka Pharmaceutical Development & Commercialization, Inc.
  More Information

Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc. Identifier: NCT01430494     History of Changes
Other Study ID Numbers: 156-10-291
Study First Received: July 29, 2011
Last Updated: April 22, 2015

Additional relevant MeSH terms:
Kidney Diseases
Polycystic Kidney Diseases
Polycystic Kidney, Autosomal Dominant
Urologic Diseases
Kidney Diseases, Cystic processed this record on May 25, 2017