UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039638
Receipt number R000045204
Scientific Title Relationship between constipation and quality of life in prevalent peritoneal dialysis patients
Date of disclosure of the study information 2020/02/28
Last modified on 2020/02/28 19:54:01

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Basic information

Public title

Relationship between constipation and quality of life in prevalent peritoneal dialysis patients

Acronym

PD and constipation

Scientific Title

Relationship between constipation and quality of life in prevalent peritoneal dialysis patients

Scientific Title:Acronym

PD and constipation

Region

Japan


Condition

Condition

CKDG5D(peritoneal dialysis)

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the relationship between the prevalence of constipation and QOL

Basic objectives2

Others

Basic objectives -Others

QOL (japanese SF-36v2; Medical Outcome Trust, QualityMetric Inc., Fukuhara S)

Trial characteristics_1

Others

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

QOL score

Key secondary outcomes

morbidity of constipation, laxatives prescription ratio, peritonitis rate, technical survival of PD, survival, hospitalization ratio


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

100 years-old >=

Gender

Male and Female

Key inclusion criteria

outpatients on peritoneal dialysis

Key exclusion criteria

none

Target sample size

80


Research contact person

Name of lead principal investigator

1st name Nanae
Middle name
Last name Matsuo

Organization

The Jikei University School of Medicine

Division name

Nephrology and Hypertension

Zip code

105-8471

Address

3-25-8, Nishi-shimbashi, Minato-ku, Tokyo

TEL

0334331111

Email

nana77m@jikei.ac.jp


Public contact

Name of contact person

1st name Nanae
Middle name
Last name Matsuo

Organization

The Jikei University School of Medicine

Division name

Nephrology and Hypertension

Zip code

105-8471

Address

3-25-8, Nishi-shimbashi, Minato-ku, Tokyo

TEL

0334331111

Homepage URL


Email

nana77m@jikei.ac.jp


Sponsor or person

Institute

Division of Nephrology and Hypertension, Departmant of Internal Medicine, The Jikei University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

self funding

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

Clinical Research Support Center, The Jikei University School of Medicine

Address

3-25-8, Nishi-shimbashi, Minato-ku, Tokyo

Tel

0334331111

Email

clresuce@jikei.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

東京慈恵会医科大学附属病院


Other administrative information

Date of disclosure of the study information

2020 Year 02 Month 28 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

2019 Year 06 Month 03 Day

Date of IRB

2019 Year 06 Month 10 Day

Anticipated trial start date

2020 Year 03 Month 01 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

peritonitis, technical survival of PD, survival, hospitalization


Management information

Registered date

2020 Year 02 Month 28 Day

Last modified on

2020 Year 02 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045204


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name