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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01430494
Recruitment Status : Completed
First Posted : September 8, 2011
Last Update Posted : April 23, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Study Design

Study Type : Observational
Actual Enrollment : 3409 participants
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
Study Start Date : June 2011
Primary Completion Date : October 2014
Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
No treatment


Outcome Measures

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

Secondary Outcome Measures :
  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 ]

Eligibility Criteria

Information from the National Library of Medicine

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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.
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01430494


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

Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT01430494     History of Changes
Other Study ID Numbers: 156-10-291
First Posted: September 8, 2011    Key Record Dates
Last Update Posted: April 23, 2015
Last Verified: April 2015

Additional relevant MeSH terms:
Kidney Diseases
Polycystic Kidney Diseases
Polycystic Kidney, Autosomal Dominant
Urologic Diseases
Kidney Diseases, Cystic
Abnormalities, Multiple
Congenital Abnormalities
Genetic Diseases, Inborn