UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013660 |
|---|---|
| Receipt number | R000015862 |
| Scientific Title | Evaluation of the diagnosis accuracy and eradication protocol of Helicobacter pylori gastritis in CKD 5 hemodialysis patients |
| Date of disclosure of the study information | 2014/04/08 |
| Last modified on | 2020/04/29 12:21:16 |
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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
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
ysakamaki-dm@umin.net
Sponsor or person
Institute
Division of Clinical Nephrology & Rheumatology, Niigata University Graduate School of Medical & Dental Sciences
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015862
