UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029817 |
|---|---|
| Receipt number | R000034065 |
| Scientific Title | Association between proton pump inhibitors and progression of abdominal aortic calcification in patients on maintenance hemodialysis |
| Date of disclosure of the study information | 2017/11/06 |
| Last modified on | 2018/12/29 09:21:39 |
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Basic information
Public title
Association between proton pump inhibitors and progression of abdominal aortic calcification in patients on maintenance hemodialysis
Acronym
Association between proton pump inhibitors and progression of abdominal aortic calcification in patients on maintenance hemodialysis
Scientific Title
Association between proton pump inhibitors and progression of abdominal aortic calcification in patients on maintenance hemodialysis
Scientific Title:Acronym
Association between proton pump inhibitors and progression of abdominal aortic calcification in patients on maintenance hemodialysis
Region
| Japan |
Condition
Condition
Chronic kidney disease with maintanace hemodialysis
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to investigate whether the long-term use of PPIs accelerates vascular calcification in patients on HD.
Basic objectives2
Others
Basic objectives -Others
factor
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To clarify the association between long-term PPIs use and progression of aortic calcification in patients with hemodialysis.
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
| 25 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Between April 2016 and September 2017,patients underwent maintenance HD or hemodiafiltration thrice a week at the Oyokyo Kidney Research Institute, Aomori, Japan.
Key exclusion criteria
Patients with severe aortic calcification, including calcification extending along the entire length and almost entire circumference of the abdominal aorta.
Patients who did not undergo abdominal CT Patients who had inappropriate intervals between subsequent CT scans.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shingo Hatakeyama |
Organization
Hirosaki University Graduate School of Medicine
Division name
Department of Urology
Zip code
Address
5 Zaifu-chou, Hirosaki 036-8562, Japan
TEL
0172-39-5091
shingoh@hirosaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Teppei Okamoto |
Organization
Oyokyo Kidney Research Institute Aomori Hospital
Division name
Department of Urology
Zip code
Address
101-1 Okabe, Ishie, Aomori 038-0003, Japan
TEL
0177819331
Homepage URL
tepperococcus@yahoo.co.jp
Sponsor or person
Institute
Oyokyo Kidney Research Institute
Institute
Department
Personal name
Funding Source
Organization
Hirosaki University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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 | 11 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1371/journal.pone.0199160
Number of participants that the trial has enrolled
Results
This study implied that PPIs was the one of independent factors associated with progression of aortic calcification among patients on maintainance HD.
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
Completed
Date of protocol fixation
| 2017 | Year | 08 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
| 2017 | Year | 10 | Month | 10 | Day |
Date trial data considered complete
| 2017 | Year | 10 | Month | 15 | Day |
Date analysis concluded
| 2017 | Year | 10 | Month | 31 | Day |
Other
Other related information
Study type:retrospective Observational Study
Object: hemodialysis Patients who received abdominal computed tomography in Oyokyo kidney research institute Aomori Hospital from April, 2016 to September, 2017.
Management information
Registered date
| 2017 | Year | 11 | Month | 03 | Day |
Last modified on
| 2018 | Year | 12 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034065
