UMIN-CTR Clinical Trial

Basic information
Public title	Investigation of the clinical significances and the pathological features of the lanthanum deposition at the gastric mucosa
Acronym	The pathological significance of gastric lanmthanum deposition
Scientific Title	Investigation of the clinical significances and the pathological features of the lanthanum deposition at the gastric mucosa
Scientific Title:Acronym	The pathological significance of gastric lanmthanum deposition
Region	Japan

Condition
Condition	patients on hemodialysis
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the lanthanum deposition at gastric mucosa
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Analysis of the clinical significances to compare the clinical feature of the LaC-users with and without La-deposition from endoscopic biopsy specimen from gastric mucosa
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	20 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	Patients on hemodialysis taking Lanthanum Carbonate
Key exclusion criteria	none
Target sample size	42

Research contact person
Name of lead principal investigator	1st name Toshihisa Middle name Last name Takeuchi
Organization	Osaka medical college hospital
Division name	Endoscopy Center
Zip code	569-8686
Address	2-7, Daigaku-machi, Takatsuki
TEL	072-683-1221
Email	in2097@osaka-med.ac.jp

Public contact
Name of contact person	1st name Kazuhiro Middle name Last name Ota
Organization	Osaka medical college
Division name	Second department of internal medicine
Zip code	569-8686
Address	2-7, Daigaku-machi, Takatsuki
TEL	072-683-1221
Homepage URL
Email	clash_kaz@yathoo.co.jp

Sponsor
Institute	Osaka medical college
Institute
Department

Funding Source
Organization	Osaka medical college
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	Moriguchi Keijinkai Hospital
Address	1-47-12, Yakumohigashi-cho, Moriguchi, Osaka
Tel	06-6906-9191
Email	shinya-nishida0608@live.jp

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	2019 Year 12 Month 20 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	42
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	2019 Year 04 Month 01 Day
Date of IRB	2019 Year 04 Month 05 Day
Anticipated trial start date	2019 Year 12 Month 19 Day
Last follow-up date	2019 Year 12 Month 19 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Original article was accepted.

Management information
Registered date	2019 Year 12 Month 19 Day
Last modified on	2020 Year 11 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044393