UMIN-CTR Clinical Trial

Basic information
Public title	Multicenter study on the current status of constipation treatment and QOL of defecation in hemodialysis patients
Acronym	Multicenter study on the current status of constipation treatment and QOL of defecation in hemodialysis patients
Scientific Title	Multicenter study on the current status of constipation treatment and QOL of defecation in hemodialysis patients
Scientific Title:Acronym	Multicenter study on the current status of constipation treatment and QOL of defecation in hemodialysis patients
Region	Japan

Condition
Condition	Chronic kidney disease
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Although attention has been focused on QOL and extragastrointestinal complications in patients with chronic constipation, especially on the inhibitory effects of cardiovascular complications and CKD (Chronic Kidney Disease), it is important to evaluate and treat QOL and gastrointestinal complications in dialysis patients. Reports are scattered, but still few. To clarify the current status of constipation treatment and QOL for defecation in multicenter hemodialysis patients
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Current status of constipation treatment and QOL on defecation in hemodialysis patients
Key secondary outcomes

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	Hemodialysis patients taking constipation medication
Key exclusion criteria	Difficult to answer due to cognitive impairment and mental illness
Target sample size	700

Research contact person
Name of lead principal investigator	1st name Sakurada Middle name Last name Tsutomu
Organization	St. Marianna University School of Medicine
Division name	devision of nephrology and hypertension
Zip code	216-8511
Address	2-16-1 Sugo, Miyama-ku, Kawasaki-shi, Kanagawa , Japan
TEL	044-977-8111
Email	y2kita@marianna-u.ac.jp

Public contact
Name of contact person	1st name Yohei Middle name Last name Kita
Organization	St. Marianna University School of Medicine
Division name	devision of nephrology and hypertension
Zip code	216-8511
Address	2-16-1 Sugo, Miyama-ku, Kawasaki-shi, Kanagawa , Japan
TEL	044-977-8111
Homepage URL
Email	y2kita@marianna-u.ac.jp

Sponsor
Institute	St. Marianna University School of Medicine
Institute
Department

Funding Source
Organization	St. Marianna University School of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	St. Marianna University School of Medicine
Address	2-16-1 Sugo, Miyama-ku, Kawasaki-shi, Kanagawa , Japan
Tel	044-977-8111
Email	y2kita@marianna-u.ac.jp

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	2020 Year 03 Month 16 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	Preinitiation
Date of protocol fixation	2020 Year 03 Month 04 Day
Date of IRB
Anticipated trial start date	2020 Year 03 Month 20 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Conduct a questionnaire survey on hemodialysis patients during dialysis

Management information
Registered date	2020 Year 03 Month 16 Day
Last modified on	2020 Year 03 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045425