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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
Recruitment hospital [6] 0 0
Otsuka Investigational Site - Launceston
Recruitment hospital [7] 0 0
Otsuka Investigational Site - Clayton
Recruitment hospital [8] 0 0
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
Recruitment postcode(s) [2] 0 0
2305 - Newcastle
Recruitment postcode(s) [3] 0 0
2031 - Sydney
Recruitment postcode(s) [4] 0 0
2050 - Sydney
Recruitment postcode(s) [5] 0 0
2065 - Sydney
Recruitment postcode(s) [6] 0 0
2139 - Sydney
Recruitment postcode(s) [7] 0 0
2145 - Westmead
Recruitment postcode(s) [8] 0 0
5000 - Adelaide
Recruitment postcode(s) [9] 0 0
7250 - Launceston
Recruitment postcode(s) [10] 0 0
3168 - Clayton
Recruitment postcode(s) [11] 0 0
3073 - Melbourne
Recruitment postcode(s) [12] 0 0
3050 - Parkville
Recruitment postcode(s) [13] 0 0
3121 - Richmond
Recruitment postcode(s) [14] 0 0
6000 - Perth
Recruitment outside Australia
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Arizona
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Edinburgh
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Kirkcaldy
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Westcliff-on-Sea
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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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01430494