UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Changes in QOL of patients with end stage renal failure and their families after initiation of peritoneal dialysis
Title of the study (Brief title)	PDQOL study
Region	Japan

Condition
Condition	end stage renal failure
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate changes in QOL of patients and their families before initiation of peritoneal dialysis to one year after
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Comparison of QOL of patients with end stage renal failure and their families before and after initiation of peritoneal dialysis
Key secondary outcomes	Factors related to QOL of peritoneal dialysis patients and their families

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	65 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	End stage renal failure patients, going to introduce peritoneal dialysis at St. Marianna Hospital or other institution at 65 years old or older, and their families
Key exclusion criteria	The patients scheduled foe kidney transplantation by one year. The patients judged inappropriate by a doctor.
Target sample size	50

Research contact person
Name of lead principal investigator	Tsutomu Sakurada
Organization	St. Marianna University
Division name	Division of Nephrology and Hypertension
Address	2-16-1 Sugao, Miyamae-ku, Kawasaki-city, Kanagawa, Japan
TEL	044-977-8111
Email	sakurda@marianna-u.ac.jp

Public contact
Name of contact person	Tsutomu Sakurada
Organization	St. Marianna University
Division name	Division of Nephrology and Hypertension
Address	2-16-1 Sugao, Miyamae-ku, Kawasaki-city, Kanagawa, Japan
TEL	044-977-8111
Homepage URL
Email	sakurada@marianna-u.ac.jp

Sponsor
Institute	St. Marianna University
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

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

Other administrative information
Date of disclosure of the study information	2017 Year 08 Month 16 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2015 Year 04 Month 14 Day
Anticipated trial start date	2016 Year 02 Month 04 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	This study is Multicenter Collaborative Prospective Registration Research. We studied end stage renal failure patients, going to initiate peritoneal dialysis at 65 years old or older, and their families. We register them from 4 Feb. 2016 to 31 Mar. 2019.

Management information
Registered date	2017 Year 08 Month 15 Day
Last modified on	2017 Year 08 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032813