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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
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
Secondary ID [1] 0 0
156-10-291
Universal Trial Number (UTN)
Trial acronym
OVERTURE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autosomal Dominant Polycystic Kidney Disease (ADPKD) 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Renal and Urogenital 0 0 0 0
Kidney disease
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
No treatment -

Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Correlation of change in total kidney volume with ADPKD-related outcomes
Timepoint [1] 0 0
1 year
Secondary outcome [1] 0 0
Patient-reported pain
Timepoint [1] 0 0
every 6 months
Secondary outcome [2] 0 0
SF-12 Scores
Timepoint [2] 0 0
every 6 months
Secondary outcome [3] 0 0
ADPKD-Impact Scale Score
Timepoint [3] 0 0
every 6 months
Secondary outcome [4] 0 0
Cost of care
Timepoint [4] 0 0
every 6 months
Secondary outcome [5] 0 0
EQ-5D Scores
Timepoint [5] 0 0
Every 6 months

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
Minimum age
12 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Current or expected (within the next six months) interventions for the treatment of ADPKD affecting kidney volume

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2014
Sample size
Target
Accrual to date
Final
3409
Recruitment in Australia
Recruitment state(s)
NSW,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Otsuka Investigational Site - Liverpool
Recruitment hospital [2] 0 0
Otsuka Investigational Site - Newcastle
Recruitment hospital [3] 0 0
Otsuka Investigational Site - Sydney
Recruitment hospital [4] 0 0
Otsuka Investigational Site - Westmead
Recruitment hospital [5] 0 0
Otsuka Investigational Site - Adelaide
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Otsuka Investigational Site - Launceston
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Otsuka Investigational Site - Clayton
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Otsuka Investigational Site - Melbourne
Recruitment hospital [9] 0 0
Otsuka Investigational Site - Parkville
Recruitment hospital [10] 0 0
Otsuka Investigational Site - Richmond
Recruitment hospital [11] 0 0
Otsuka Investigational Site - Perth
Recruitment postcode(s) [1] 0 0
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
Recruitment postcode(s) [6] 0 0
2139 - Sydney
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2145 - Westmead
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5000 - Adelaide
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7250 - Launceston
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3168 - Clayton
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3073 - Melbourne
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3050 - Parkville
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3121 - Richmond
Recruitment postcode(s) [14] 0 0
6000 - Perth
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Otsuka Pharmaceutical Development & Commercialization, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Otsuka Pharmaceutical Co., Ltd.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT01430494
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Frank Czerwiec, MD, PhD
Address 0 0
Otsuka Pharmaceutical Development & Commercialization, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01430494