Trial document




This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00006495

Trial Description

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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

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Trial Acronym

OVERTURE

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URL of the Trial

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00006495
  •   2015/03/26
  •   2011/07/29
  •   no
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Secondary IDs

  •   NCT01430494  (ClinicalTrials.gov)
  •   156-10-291  (Otsuka Pharmaceutical Development & Commercialization, Inc.)
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Health Condition or Problem studied

  •   Autosomal Dominant Polycystic Kidney Disease (ADPKD)
  •   Q61.2 -  Polycystic kidney, autosomal dominant
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Interventions/Observational Groups

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Characteristics

  •   Non-interventional
  •   Observational study
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  •   N/A
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Primary Outcome

- Correlation of change in total kidney volume with ADPKD-related outcomes; time frame: 1 year

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Secondary Outcome

- 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

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Countries of Recruitment

  •   United States
  •   Argentina
  •   Australia
  •   Belgium
  •   Brazil
  •   Canada
  •   Czech Republic
  •   France
  •   Germany
  •   Italy
  •   Japan
  •   Netherlands
  •   Norway
  •   Poland
  •   Romania
  •   Spain
  •   Sweden
  •   Switzerland
  •   Turkey
  •   United Kingdom
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Locations of Recruitment

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Recruitment

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  •   2011/06/30
  •   3000
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   12   Years
  •   70   Years
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Additional 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

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Exclusion Criteria

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

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Addresses

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    • Otsuka Pharmaceutical Development & Commercialization, Inc.
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    • Otsuka Pharmaceutical Co., Ltd.
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    • Otsuka Pharmaceutical Development & Commercialization, Inc.
    • Frank Czerwiec, MD, PhD 
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    • Otsuka Pharmaceutical Development & Commercialization, Inc.
    • Frank Czerwiec, MD, PhD 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting complete, follow-up continuing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   2
  •   2014/07/16
* This entry means the parameter is not applicable or has not been set.