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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000007623
Receipt No. R000006889
Scientific Title Quality of life (QOL) of patients with autosomal dominant polycystic kidney disease (ADPKD): Influence of renal TAE or hepatic TAE on QOL.
Date of disclosure of the study information 2012/03/30
Last modified on 2015/03/30

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Basic information
Public title Quality of life (QOL) of patients with autosomal dominant polycystic kidney disease (ADPKD): Influence of renal TAE or hepatic TAE on QOL.
Acronym Toranomon PKD QOL study
Scientific Title Quality of life (QOL) of patients with autosomal dominant polycystic kidney disease (ADPKD): Influence of renal TAE or hepatic TAE on QOL.
Scientific Title:Acronym Toranomon PKD QOL study
Region
Japan

Condition
Condition Autosomal dominant polycystic kidney disease (ADPKD)
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate how the QOL of patients with ADPKD is improved by renal or hepatic TAE.
Basic objectives2 Others
Basic objectives -Others To identify factors influencing the QOL of patients with ADPKD.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Physical component summary (PCS), mental component summary (MCS), and role/social component summary (RCS) of the Short Form-36 (SF-36) version 2.
Key secondary outcomes Ten questions about specific symptoms in patients with ADPKD, such as abdominal distension, poor appetite, and sleep disturbance.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria All patients with ADPKD referred to Toranomon Hospital from March 2010.
Key exclusion criteria Patients who received renal or hepatic TAE before March 2010 or patients who did not agree to participate in this research were excluded.
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tatsuya Suwabe
Organization Toranomon Hospital
Division name Department of Nephrology
Zip code
Address 1-3-1 Kajigaya, Takatsu-ku, Kawasaki-shi, Kanagawa-ken, 213-0015, Japan
TEL 044-877-5111
Email suwabe@toranomon.gr.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tatsuya Suwabe
Organization Toranomon Hospital
Division name Department of Nephrology
Zip code
Address 1-3-1 Kajigaya Takatsu-ku Kawasaki Kanagawa Japan
TEL 044-877-5111
Homepage URL
Email suwabe@toranomon.gr.jp

Sponsor
Institute Department of Nephrology, Toranomon Hospital
Institute
Department

Funding Source
Organization Toranomon Hospital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 虎の門病院腎センター Department Nephrology, Toranomon Hospital, Tokyo Japan

Other administrative information
Date of disclosure of the study information
2012 Year 03 Month 30 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2010 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We have performed renal cyst therapy by renal or hepatic transcatheter arterial embolization (TAE) in patients with enlarged kidney or liver since 1996. TAE is performed in patients with ADPKD who wish to undergo the procedure to alleviate compression symptoms related to their enlarged kidneys or liver, and who do not have any contraindications for TAE. We have previously reported on the effectiveness of such therapy for reducing the hepatic or renal volume. However, it has been unclear whether TAE actually improves the quality of life (QOL) of ADPKD patients. Therefore, we decided to perform a questionnaire survey to evaluate how TAE affects the QOL of patients by using the SF-36 and 10 other questions about specific symptoms of patients with ADPKD. This questionnaire survey will be performed before TAE, as well as 1 month, 3 months, 6 months, and 12 months after TAE. For comparison, a questionnaire survey will also be performed every year in patients with ADPKD who have not received TAE. Correlations between QOL and age, renal function, renal volume, and liver volume will be analyzed.

Management information
Registered date
2012 Year 03 Month 30 Day
Last modified on
2015 Year 03 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006889

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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