UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of the diagnosis accuracy and eradication protocol of Helicobacter pylori gastritis in CKD 5 hemodialysis patients
Acronym	The diagnosis and eradication of Helicobacter pylori in CKD
Scientific Title	Evaluation of the diagnosis accuracy and eradication protocol of Helicobacter pylori gastritis in CKD 5 hemodialysis patients
Scientific Title:Acronym	The diagnosis and eradication of Helicobacter pylori in CKD
Region	Japan

Condition
Condition	Hemodialysis patients with Helicobacter pylori gastritis
Classification by specialty	Gastroenterology Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In dialysis patients with a Helicobacter pylori gastritis, to evaluate the efficacy and accuracy of different diagnosis methods for Helicobacter pylori gastritis and the possibility of dose reduction on eradication therapy of the disease.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase IV

Assessment
Primary outcomes	Eradication rate for Helicobacter pyroli
Key secondary outcomes	Sensitivity and specificity of anti-Helicobacter pylori Antibody-IgG, Dry weight during dialysis, blood pressure, body weight, chest X-ray CTR, hemoglobin, dose of ESA, serum iron, UIBC (not to TIBC), ferritin, CRP.

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	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patients of CKD stage G4 ~ 5 (eGFR <= 30, including hemodialysis patients 2) Patients were revealed as chronic gastritis by upper gastrointestinal fiberscopy 2) Outpatients with relatively stable renal function. 3) Patients who can take medication orally. 4) Patients who can receive blood tests. 5) Patients that agreed to diagnosis and treatment of H.pyroli. 6) Men and women aged over 20 years old
Key exclusion criteria	1) Patients with a history of hypersensitivity for amoxicillin, clarithromycin, proton pump inhibitors, or metronidazole. 2) Of the patients with CKD, the patient being predicted for initiating dialysis within six months. 3) Patients complicated with acute inflammatory disease or active infection. 4) Patients with active malignant tumor. 5) Patients who suspected of being pregnant or pregnancy. 6) Patients did not make a consent for test and/or treatment of H. pyroli gastritis. 7) Patients was determined to be difficult to continue the eradication therapy by serious adverse events. 8) Patients offer discontinuation of the study. 9) Attending physician deems the patients as unsuitable of the study.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Middle name Last name Ichiei NARITA
Organization	Niigata University Graduate School of Medical & Dental Sciences
Division name	Division of Clinical Nephrology & Rheumatology
Zip code
Address	1-757 Asahimachi-Dori, Chuo-Ku, Niigata, 951-8510 Japan
TEL	+81-25-227-2200
Email	naritai@med.niigata-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Yuichi SAKAMAKI
Organization	Niigata University Graduate School of Medical & Dental Sciences
Division name	Division of Clinical Nephrology & Rheumatology
Zip code
Address	1-757 Asahimachi-Dori, Chuo-Ku, Niigata, 951-8510 Japan
TEL	+81-25-227-2200
Homepage URL
Email	ysakamaki-dm@umin.net

Sponsor
Institute	Division of Clinical Nephrology & Rheumatology, Niigata University Graduate School of Medical & Dental Sciences
Institute
Department

Funding Source
Organization	none
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
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	新潟大学医歯学総合病院(新潟県) 財団法人　小千谷総合病院(新潟県)

Other administrative information
Date of disclosure of the study information	2014 Year 04 Month 08 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	2014 Year 01 Month 01 Day
Date of IRB	2014 Year 04 Month 01 Day
Anticipated trial start date	2014 Year 04 Month 08 Day
Last follow-up date	2014 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Relevance of eradication rate and dose reduction of antibacterial drugs in Helocobacter pylori eradication therapy. Retrospective study.

Management information
Registered date	2014 Year 04 Month 07 Day
Last modified on	2020 Year 04 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015862