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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01430494
Registration number
NCT01430494
Ethics application status
Date submitted
29/07/2011
Date registered
8/09/2011
Date last updated
23/04/2015
Titles & IDs
Public title
Observational Study in Patients With Autosomal Dominant Polycystic Kidney Disease
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Scientific 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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Secondary ID [1]
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156-10-291
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Universal Trial Number (UTN)
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Trial acronym
OVERTURE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Autosomal Dominant Polycystic Kidney Disease (ADPKD)
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Condition category
Condition code
Musculoskeletal
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0
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Other muscular and skeletal disorders
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Renal and Urogenital
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0
0
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Kidney disease
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Renal and Urogenital
0
0
0
0
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Other renal and urogenital disorders
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Human Genetics and Inherited Disorders
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0
0
0
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Other human genetics and inherited disorders
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
No treatment -
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Correlation of change in total kidney volume with ADPKD-related outcomes
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Assessment method [1]
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Timepoint [1]
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1 year
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Secondary outcome [1]
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Patient-reported pain
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Assessment method [1]
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Timepoint [1]
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every 6 months
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Secondary outcome [2]
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SF-12 Scores
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Assessment method [2]
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Timepoint [2]
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every 6 months
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Secondary outcome [3]
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ADPKD-Impact Scale Score
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Assessment method [3]
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Timepoint [3]
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every 6 months
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Secondary outcome [4]
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Cost of care
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Assessment method [4]
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Timepoint [4]
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every 6 months
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Secondary outcome [5]
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EQ-5D Scores
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Assessment method [5]
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Timepoint [5]
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Every 6 months
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Eligibility
Key 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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Minimum age
12
Years
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Maximum age
70
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Current or expected (within the next six months) interventions for the treatment of ADPKD affecting kidney volume
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/06/2011
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/10/2014
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Sample size
Target
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Accrual to date
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Final
3409
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Recruitment in Australia
Recruitment state(s)
NSW,SA,TAS,VIC,WA
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Recruitment hospital [1]
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Otsuka Investigational Site - Liverpool
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Otsuka Investigational Site - Newcastle
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Recruitment postcode(s) [1]
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2170 - Liverpool
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2305 - Newcastle
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2031 - Sydney
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2050 - Sydney
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2065 - Sydney
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Recruitment postcode(s) [6]
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2139 - Sydney
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Recruitment postcode(s) [7]
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2145 - Westmead
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Recruitment postcode(s) [8]
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5000 - Adelaide
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Recruitment postcode(s) [9]
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7250 - Launceston
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Recruitment postcode(s) [10]
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3168 - Clayton
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Recruitment postcode(s) [11]
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3073 - Melbourne
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Recruitment postcode(s) [12]
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3050 - Parkville
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Recruitment postcode(s) [13]
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3121 - Richmond
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Recruitment postcode(s) [14]
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6000 - Perth
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Recruitment outside Australia
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Oxford
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Southampton
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Wolverhampton
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Otsuka Pharmaceutical Development & Commercialization, Inc.
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Other collaborator category [1]
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Commercial sector/industry
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Otsuka Pharmaceutical Co., Ltd.
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT01430494
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Contacts
Principal investigator
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Frank Czerwiec, MD, PhD
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Otsuka Pharmaceutical Development & Commercialization, Inc.
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
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https://clinicaltrials.gov/study/NCT01430494
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