UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The relationship among plasma ghrelin level and H. pylori infection and eradication therapy in patients with chronic kidney disease
Title of the study (Brief title)	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	Hitomi Ichikawa
Organization	Hamamatsu University School of Medicine
Division name	First Department of Mediine
Address	1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka, Japan
TEL	053-435-2261
Email	hito0215@hama-med.ac.jp

Public contact
Name of contact person	Hitomi Ichikawa
Organization	Hamamatsu University School of Medicine
Division name	First Department of Mediine
Address	1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka, Japan
TEL	053-435-2261
Homepage URL
Email	hito0215@hama-med.ac.jp

Sponsor
Institute	Hamamatsu University School of Medicine
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 04 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026821