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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: March 13, 2013
Last verified: March 2013
History of Changes
  Purpose

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
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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 3000
Study Start Date: June 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
No treatment

  Eligibility

Ages Eligible for Study:   12 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01430494

  Show 233 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

No publications provided

Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT01430494     History of Changes
Other Study ID Numbers: 156-10-291
Study First Received: July 29, 2011
Last Updated: March 13, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Kidney Diseases
Polycystic Kidney Diseases
Polycystic Kidney, Autosomal Dominant
Disease Progression
 Urologic Diseases
Kidney Diseases, Cystic
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013