Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Text Size

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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Otsuka Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier:
NCT01430494
First received: July 29, 2011
Last updated: February 6, 2014
Last verified: February 2014
History of Changes

July 29, 2011
February 6, 2014
June 2011
September 2014   (final data collection date for primary outcome measure)
Correlation of change in total kidney volume with ADPKD-related outcomes [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01430494 on ClinicalTrials.gov Archive Site
  • Patient-reported pain [ Time Frame: every 6 months ] [ Designated as safety issue: No ]
  • SF-12 Scores [ Time Frame: every 6 months ] [ Designated as safety issue: No ]
  • ADPKD-Impact Scale Score [ Time Frame: every 6 months ] [ Designated as safety issue: No ]
  • Cost of care [ Time Frame: every 6 months ] [ Designated as safety issue: No ]
  • EQ-5D Scores [ Time Frame: Every 6 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Observational Study in Patients With Autosomal Dominant Polycystic Kidney Disease
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Subjects will be identified by participating clinics (primarily nephrology clinics) treating patients with ADPKD.
Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Not Provided
No treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
3000
September 2014
September 2014   (final data collection date for primary outcome measure)

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
Both
12 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Belgium,   Brazil,   Canada,   Czech Republic,   France,   Germany,   Italy,   Japan,   Netherlands,   Norway,   Poland,   Romania,   Spain,   Sweden,   Switzerland,   Turkey,   United Kingdom
 
NCT01430494
156-10-291
No
Otsuka Pharmaceutical Development & Commercialization, Inc.
Otsuka Pharmaceutical Development & Commercialization, Inc.
Otsuka Pharmaceutical Co., Ltd.
Study Director: Frank Czerwiec, MD, PhD Otsuka Pharmaceutical Development & Commercialization, Inc.
Otsuka Pharmaceutical Development & Commercialization, Inc.
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP