Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
District of Columbia
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Idaho
Country [9] 0 0
United States of America
State/province [9] 0 0
Illinois
Country [10] 0 0
United States of America
State/province [10] 0 0
Indiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Kansas
Country [12] 0 0
United States of America
State/province [12] 0 0
Kentucky
Country [13] 0 0
United States of America
State/province [13] 0 0
Louisiana
Country [14] 0 0
United States of America
State/province [14] 0 0
Maryland
Country [15] 0 0
United States of America
State/province [15] 0 0
Massachusetts
Country [16] 0 0
United States of America
State/province [16] 0 0
Michigan
Country [17] 0 0
United States of America
State/province [17] 0 0
Minnesota
Country [18] 0 0
United States of America
State/province [18] 0 0
Missouri
Country [19] 0 0
United States of America
State/province [19] 0 0
Nevada
Country [20] 0 0
United States of America
State/province [20] 0 0
New Jersey
Country [21] 0 0
United States of America
State/province [21] 0 0
New Mexico
Country [22] 0 0
United States of America
State/province [22] 0 0
New York
Country [23] 0 0
United States of America
State/province [23] 0 0
North Carolina
Country [24] 0 0
United States of America
State/province [24] 0 0
North Dakota
Country [25] 0 0
United States of America
State/province [25] 0 0
Ohio
Country [26] 0 0
United States of America
State/province [26] 0 0
Oregon
Country [27] 0 0
United States of America
State/province [27] 0 0
Pennsylvania
Country [28] 0 0
United States of America
State/province [28] 0 0
Rhode Island
Country [29] 0 0
United States of America
State/province [29] 0 0
South Carolina
Country [30] 0 0
United States of America
State/province [30] 0 0
South Dakota
Country [31] 0 0
United States of America
State/province [31] 0 0
Tennessee
Country [32] 0 0
United States of America
State/province [32] 0 0
Texas
Country [33] 0 0
United States of America
State/province [33] 0 0
Vermont
Country [34] 0 0
United States of America
State/province [34] 0 0
Virginia
Country [35] 0 0
United States of America
State/province [35] 0 0
West Virginia
Country [36] 0 0
United States of America
State/province [36] 0 0
Wisconsin
Country [37] 0 0
Argentina
State/province [37] 0 0
Buenos Aires
Country [38] 0 0
Argentina
State/province [38] 0 0
C.a.b.a.
Country [39] 0 0
Argentina
State/province [39] 0 0
Ciudad Autonoma de Buenos Aires
Country [40] 0 0
Argentina
State/province [40] 0 0
Ciudad de Buenos Aires
Country [41] 0 0
Argentina
State/province [41] 0 0
Cordoba
Country [42] 0 0
Argentina
State/province [42] 0 0
Sante Fe
Country [43] 0 0
Belgium
State/province [43] 0 0
Brussels
Country [44] 0 0
Belgium
State/province [44] 0 0
Gent
Country [45] 0 0
Belgium
State/province [45] 0 0
Leuven
Country [46] 0 0
Brazil
State/province [46] 0 0
MG
Country [47] 0 0
Brazil
State/province [47] 0 0
PR
Country [48] 0 0
Brazil
State/province [48] 0 0
RS
Country [49] 0 0
Brazil
State/province [49] 0 0
SC
Country [50] 0 0
Brazil
State/province [50] 0 0
SP
Country [51] 0 0
Brazil
State/province [51] 0 0
São Paulo
Country [52] 0 0
Canada
State/province [52] 0 0
British Columbia
Country [53] 0 0
Canada
State/province [53] 0 0
Newfoundland and Labrador
Country [54] 0 0
Canada
State/province [54] 0 0
Nova Scotia
Country [55] 0 0
Canada
State/province [55] 0 0
Ontario
Country [56] 0 0
Canada
State/province [56] 0 0
Quebec
Country [57] 0 0
Czech Republic
State/province [57] 0 0
Ceske Budejovice
Country [58] 0 0
Czech Republic
State/province [58] 0 0
Hradec Kralove
Country [59] 0 0
Czech Republic
State/province [59] 0 0
Jihlava
Country [60] 0 0
Czech Republic
State/province [60] 0 0
Liberec
Country [61] 0 0
Czech Republic
State/province [61] 0 0
Praha 2
Country [62] 0 0
France
State/province [62] 0 0
Caen cedex 9
Country [63] 0 0
France
State/province [63] 0 0
Grenoble cedex
Country [64] 0 0
France
State/province [64] 0 0
Lyon cedex 03
Country [65] 0 0
France
State/province [65] 0 0
Lyon cedex 3
Country [66] 0 0
France
State/province [66] 0 0
Montpellier cedex
Country [67] 0 0
France
State/province [67] 0 0
Pierre-Bénite cedex
Country [68] 0 0
France
State/province [68] 0 0
Vandoeuvre-lès-Nancy cedex
Country [69] 0 0
Germany
State/province [69] 0 0
Berlin
Country [70] 0 0
Germany
State/province [70] 0 0
Dresden
Country [71] 0 0
Germany
State/province [71] 0 0
Düsseldorf
Country [72] 0 0
Germany
State/province [72] 0 0
Erlangen
Country [73] 0 0
Germany
State/province [73] 0 0
Hannover
Country [74] 0 0
Germany
State/province [74] 0 0
Heidelburg
Country [75] 0 0
Germany
State/province [75] 0 0
Munich
Country [76] 0 0
Germany
State/province [76] 0 0
Wiesbaden
Country [77] 0 0
Italy
State/province [77] 0 0
Milano
Country [78] 0 0
Italy
State/province [78] 0 0
Bologna
Country [79] 0 0
Italy
State/province [79] 0 0
Lecco
Country [80] 0 0
Italy
State/province [80] 0 0
Modena
Country [81] 0 0
Italy
State/province [81] 0 0
Montichiari, (Brescia)
Country [82] 0 0
Italy
State/province [82] 0 0
Napoli
Country [83] 0 0
Italy
State/province [83] 0 0
Pavia
Country [84] 0 0
Japan
State/province [84] 0 0
Kanagawa
Country [85] 0 0
Japan
State/province [85] 0 0
Okayama
Country [86] 0 0
Japan
State/province [86] 0 0
Chiba
Country [87] 0 0
Japan
State/province [87] 0 0
Fukuoka
Country [88] 0 0
Japan
State/province [88] 0 0
Hokkaido
Country [89] 0 0
Japan
State/province [89] 0 0
Niigata
Country [90] 0 0
Japan
State/province [90] 0 0
Osaka
Country [91] 0 0
Japan
State/province [91] 0 0
Tochigi
Country [92] 0 0
Japan
State/province [92] 0 0
Tokyo
Country [93] 0 0
Netherlands
State/province [93] 0 0
Groningen
Country [94] 0 0
Netherlands
State/province [94] 0 0
Leiden
Country [95] 0 0
Netherlands
State/province [95] 0 0
Nijmegen
Country [96] 0 0
Netherlands
State/province [96] 0 0
Rotterdam
Country [97] 0 0
Norway
State/province [97] 0 0
Drammen
Country [98] 0 0
Norway
State/province [98] 0 0
Lillehammer
Country [99] 0 0
Poland
State/province [99] 0 0
Ciechanow
Country [100] 0 0
Poland
State/province [100] 0 0
Golub-Dobrzyn
Country [101] 0 0
Poland
State/province [101] 0 0
Krakow
Country [102] 0 0
Poland
State/province [102] 0 0
Lodz
Country [103] 0 0
Poland
State/province [103] 0 0
Radom
Country [104] 0 0
Poland
State/province [104] 0 0
Rzeszów
Country [105] 0 0
Poland
State/province [105] 0 0
Szczecin
Country [106] 0 0
Poland
State/province [106] 0 0
Warsaw
Country [107] 0 0
Poland
State/province [107] 0 0
Warszawa
Country [108] 0 0
Poland
State/province [108] 0 0
Wroclaw
Country [109] 0 0
Romania
State/province [109] 0 0
Bihor
Country [110] 0 0
Romania
State/province [110] 0 0
Timis
Country [111] 0 0
Romania
State/province [111] 0 0
Bucuresti
Country [112] 0 0
Spain
State/province [112] 0 0
Alicante
Country [113] 0 0
Spain
State/province [113] 0 0
Barcelona
Country [114] 0 0
Spain
State/province [114] 0 0
Ciudad Real
Country [115] 0 0
Spain
State/province [115] 0 0
Hospitalet de Ilobre
Country [116] 0 0
Spain
State/province [116] 0 0
Madrid
Country [117] 0 0
Sweden
State/province [117] 0 0
Malmö
Country [118] 0 0
Sweden
State/province [118] 0 0
Stockholm
Country [119] 0 0
Switzerland
State/province [119] 0 0
Zürich
Country [120] 0 0
Turkey
State/province [120] 0 0
Capa
Country [121] 0 0
Turkey
State/province [121] 0 0
Izmir
Country [122] 0 0
Turkey
State/province [122] 0 0
Balcali-Adana
Country [123] 0 0
Turkey
State/province [123] 0 0
Bornova-Izmir
Country [124] 0 0
Turkey
State/province [124] 0 0
Sihhiye-Ankara
Country [125] 0 0
United Kingdom
State/province [125] 0 0
Devon
Country [126] 0 0
United Kingdom
State/province [126] 0 0
North Yorkshire
Country [127] 0 0
United Kingdom
State/province [127] 0 0
Staffordshire
Country [128] 0 0
United Kingdom
State/province [128] 0 0
Surrey
Country [129] 0 0
United Kingdom
State/province [129] 0 0
West Midlands
Country [130] 0 0
United Kingdom
State/province [130] 0 0
Belfast
Country [131] 0 0
United Kingdom
State/province [131] 0 0
Bradford
Country [132] 0 0
United Kingdom
State/province [132] 0 0
Bristol
Country [133] 0 0
United Kingdom
State/province [133] 0 0
Cambridge
Country [134] 0 0
United Kingdom
State/province [134] 0 0
Chelmsford
Country [135] 0 0
United Kingdom
State/province [135] 0 0
Coventry
Country [136] 0 0
United Kingdom
State/province [136] 0 0
Dorchester
Country [137] 0 0
United Kingdom
State/province [137] 0 0
Edinburgh
Country [138] 0 0
United Kingdom
State/province [138] 0 0
Hull
Country [139] 0 0
United Kingdom
State/province [139] 0 0
Inverness
Country [140] 0 0
United Kingdom
State/province [140] 0 0
Kirkcaldy
Country [141] 0 0
United Kingdom
State/province [141] 0 0
Leicester
Country [142] 0 0
United Kingdom
State/province [142] 0 0
Liverpool
Country [143] 0 0
United Kingdom
State/province [143] 0 0
London
Country [144] 0 0
United Kingdom
State/province [144] 0 0
Manchester
Country [145] 0 0
United Kingdom
State/province [145] 0 0
Middlesbrough
Country [146] 0 0
United Kingdom
State/province [146] 0 0
Newcastle Upon Tyne
Country [147] 0 0
United Kingdom
State/province [147] 0 0
Oxford
Country [148] 0 0
United Kingdom
State/province [148] 0 0
Portsmouth
Country [149] 0 0
United Kingdom
State/province [149] 0 0
Preston
Country [150] 0 0
United Kingdom
State/province [150] 0 0
Salford
Country [151] 0 0
United Kingdom
State/province [151] 0 0
Sheffield
Country [152] 0 0
United Kingdom
State/province [152] 0 0
Southampton
Country [153] 0 0
United Kingdom
State/province [153] 0 0
Stevenage
Country [154] 0 0
United Kingdom
State/province [154] 0 0
Westcliff-on-Sea
Country [155] 0 0
United Kingdom
State/province [155] 0 0
Wolverhampton

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/ct2/show/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