UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011547
Receipt number R000013507
Scientific Title Impact of Abdominal Artery Calcification for Gastrointestinal complication on Hemodialysis (Multi-institutional cross sectional study)
Date of disclosure of the study information 2013/09/01
Last modified on 2014/10/25 21:41:20

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Basic information

Public title

Impact of Abdominal Artery Calcification for Gastrointestinal complication on Hemodialysis
(Multi-institutional cross sectional study)

Acronym

Abdominal artery calcification in hemodialysis patients

Scientific Title

Impact of Abdominal Artery Calcification for Gastrointestinal complication on Hemodialysis
(Multi-institutional cross sectional study)

Scientific Title:Acronym

Abdominal artery calcification in hemodialysis patients

Region

Japan


Condition

Condition

Chronic renal failure

Classification by specialty

Gastroenterology Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Evaluation of the relationships among abdominal artery calcification , CKD-MBD factors and gastrointestinal complication (abdominal angina and chronic symptoms)

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

1. Acute abdominal symptoms: the frequency of abdominal angina while hemodialysis treating
2. Chronic abdominal symptoms: the degree of nausea, epigastralgia, fullness, constipation and diarrhea using Izumo Scale

Key secondary outcomes

The severity of abdominal artery calcification
(abdominal aorta,celiac artery,superior mesenteric artery,inferior mesenteric artery)


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

80 years-old >

Gender

Male and Female

Key inclusion criteria

Patients who fell all of the following categories are taken to the study. The patients:
1. a.) have been suffering from chronic renal failure with anuria or oligouria
b.) have treated hemodialysis three times a day over one year
c.) have urinary volume less than 200ml/day
2. are able to judge by themselves
3. are able to sign informed consent with free will upon a clear appreciation and understanding of the study
4. are able to continue to be treated at same hospital or clinic while the study is implemented

Key exclusion criteria

1.history of abdominal operation
2.undergoing severe gastrointestinal complication
3.women who are pregnant or have possibility of being pregnant
4.severe systemic disease
5.be judged unfit for this trial by doctors

Target sample size

500


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazuo Fukumoto

Organization

Hata Hospital

Division name

Medical director

Zip code


Address

10-12 Uyamatenjin-cho,Shimanto-city, Kochi prefecture

TEL

0880-34-6211

Email

simahata@mb.inforyoma.or.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kazuo Fukumoto

Organization

Hata Hospital

Division name

Medical director

Zip code


Address

10-12 Uyamatenjin-cho,Shimanto-city, Kochi prefecture

TEL

0880-34-6211

Homepage URL


Email

simahata@mb.inforyoma.or.jp


Sponsor or person

Institute

Hata Hospital

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

none


Other related organizations

Co-sponsor

Hata Hosp
Shigei Hosp
Maeda Clinic
Hojo Hosp
Matsuoka Naika Clinic
Aishin Memorial Hosp
Shimazu Hosp
Date Clinic
Takeshita Hosp
Kubokawa Hosp
Inan Hosp
Kochi Rehabilitation Hosp

Name of secondary funder(s)

none


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

医療法人島津会 幡多病院 (高知県) Hata Hospital
医療法人創和会 しげい病院 (岡山県) Shigei Hospital
医療法人社団兼愛会 前田医院 (長崎県) Maeda Clinic
医療法人社団樹人会 北条病院 (愛媛県) Hojo Hospital
医療法人社団大誠会 松岡内科クリニック (岐阜県) Matsuoka Naika Clinic
医療法人社団愛心館 愛心メモリアル病院 (北海道) Aishin Memorial Hospital
医療法人仁栄会 島津病院 (高知県) Shimazu Hospital
医療法人社団腎愛会 だてクリニック (北海道) Date Clinic
特定医療法人竹下会 竹下病院 (高知県) Takeshita Hospital
医療法人川村会 くぼかわ病院 (高知県) Kubokawa Hospital
医療法人聖真会 渭南病院(高知県) Inan Hospital
社団法人全国社会保険協会連合会 厚生年金高知リハビリテーション病院(高知県) Koseinenkin Kochi Rehabilitation Hospital


Other administrative information

Date of disclosure of the study information

2013 Year 09 Month 01 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

The association between abdominal artey calcification and abdominal pain or abdominal angina during hemodialysis treatment

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

Terminated

Date of protocol fixation

2013 Year 08 Month 02 Day

Date of IRB


Anticipated trial start date

2013 Year 09 Month 01 Day

Last follow-up date

2014 Year 08 Month 31 Day

Date of closure to data entry

2014 Year 08 Month 31 Day

Date trial data considered complete

2014 Year 08 Month 31 Day

Date analysis concluded

2014 Year 08 Month 31 Day


Other

Other related information

The association between chronic gastrointestinal symptoms and quality of life in hemodialysis patients


Management information

Registered date

2013 Year 08 Month 21 Day

Last modified on

2014 Year 10 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013507


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name