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

Tracking Information
First Submitted Date	July 29, 2011
First Posted Date	September 8, 2011
Last Update Posted Date	April 23, 2015
Study Start Date	June 2011
Actual Primary Completion Date	October 2014 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures; (submitted: September 6, 2011)	Correlation of change in total kidney volume with ADPKD-related outcomes [ Time Frame: 1 year ]
Original Primary Outcome Measures	Same as current
Change History	Complete list of historical versions of study NCT01430494 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures; (submitted: September 6, 2011)	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 ]
Original Secondary Outcome Measures	Same as current
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	Observational Study in Patients With Autosomal Dominant Polycystic Kidney Disease
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
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.
Detailed Description	Not Provided
Study Type	Observational
Study Design	Observational Model: Cohort; Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	Subjects will be identified by participating clinics (primarily nephrology clinics) treating patients with ADPKD.
Condition	Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Intervention	Not Provided
Study Groups/Cohorts	No treatment
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Completed
Actual Enrollment; (submitted: April 22, 2015)	3409
Original Estimated Enrollment; (submitted: September 6, 2011)	3000
Actual Study Completion Date	October 2014
Actual Primary Completion Date	October 2014 (Final data collection date for primary outcome measure)
Eligibility Criteria	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
Sex/Gender	Sexes Eligible for Study: All
Ages	12 Years to 70 Years (Child, Adult, Senior)
Accepts Healthy Volunteers	No
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	Argentina, Australia, Belgium, Brazil, Canada, Czech Republic, France, Germany, Italy, Japan, Netherlands, Norway, Poland, Romania, Spain, Sweden, Switzerland, Turkey, United Kingdom, United States
Removed Location Countries
Administrative Information
NCT Number	NCT01430494
Other Study ID Numbers	156-10-291
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Sponsor	Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators	Otsuka Pharmaceutical Co., Ltd.
Investigators	Study Director: Frank Czerwiec, MD, PhD Otsuka Pharmaceutical Development & Commercialization, Inc.
PRS Account	Otsuka Pharmaceutical Development & Commercialization, Inc.
Verification Date	April 2015