UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023336 |
|---|---|
| Receipt number | R000026821 |
| Scientific Title | The relationship among plasma ghrelin level and H. pylori infection and eradication therapy in patients with chronic kidney disease |
| Date of disclosure of the study information | 2016/07/26 |
| Last modified on | 2017/07/29 12:11:52 |
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Basic information
Public title
The relationship among plasma ghrelin level and H. pylori infection and eradication therapy in patients with chronic kidney disease
Acronym
Ghrelin and H. pylori in chronic kidney disease patients
Scientific Title
The relationship among plasma ghrelin level and H. pylori infection and eradication therapy in patients with chronic kidney disease
Scientific Title:Acronym
Ghrelin and H. pylori in chronic kidney disease patients
Region
| Japan |
Condition
Condition
Hemodialysis patients and non-dialysis patients with chronic kidney disease
Classification by specialty
| Medicine in general | Gastroenterology | Nephrology |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the associations between plasma ghrelin level and clinical parameters (e.g., nutrition and H. pylori infection, severity of gastric mucosal atrophy) in hemodialysis patients and non-dialysis patients with chronic kidney disease and to clarify improvenemnt of above parameters by H. pylori eradication therapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Association with plasme ghrelin levels and gastric mucosal atrophy in hemodialysis patients
Key secondary outcomes
1)Association with plasme ghrelin levels and H. pylori infection in hemodialysis patients
2)H. pyloti infection rate in CKD patients
3)Association with plasme ghrelin levels and mutrition markers in CKD patients
4)Prevalence of the upper gastrointestinal disease in CKD patients
5)Eradication rate of H. pylori in CKD patients
6)Change of plasma ghlerin levels after eradicaion therapy
7)Change of nutrition markers after eradicaion therapy
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
H. pylori eradication therapy
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
(1)With chronic renal dysfunction including hemodialysis
(2)Receiving gastroduodenal endoscopy
Key exclusion criteria
(1)Having a H. pylori eradication history
(2)With history of gastrectomy
(3)With significant clinical illness (e.g., cancer)
(4)Lack of informed consent
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hitomi Ichikawa |
Organization
Hamamatsu University School of Medicine
Division name
First Department of Mediine
Zip code
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka, Japan
TEL
053-435-2261
hito0215@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hitomi Ichikawa |
Organization
Hamamatsu University School of Medicine
Division name
First Department of Mediine
Zip code
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka, Japan
TEL
053-435-2261
Homepage URL
hito0215@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japanese Assosiation of Dialysis Physicians
Organization
Division
Category of Funding Organization
Other
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
| 2016 | Year | 07 | Month | 26 | 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
Completed
Date of protocol fixation
| 2012 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 05 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 07 | Month | 26 | Day |
Last modified on
| 2017 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026821
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
