UMIN-CTR Clinical Trial

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

Autosomal dominant polycystic kidney disease (ADPKD)

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Department of Nephrology, Toranomon Hospital

Institute

Department

Personal name

Organization

Toranomon Hospital

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

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

Date of disclosure of the study information

2012

Year

03

Month

30

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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.

Registered date

2012

Year

03

Month

30

Day

Last modified on

2015

Year

03

Month

30

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006889