UMIN-CTR Clinical Trial

Basic information
Public title	Investigation of the association between proton pump inhibitors and risk of adverse drug reactions using the Japanese medical database.
Acronym	Investigation of the association between proton pump inhibitors and risk of adverse drug reactions using the Japanese medical database.
Scientific Title	Investigation of the association between proton pump inhibitors and risk of adverse drug reactions using the Japanese medical database.
Scientific Title:Acronym	Investigation of the association between proton pump inhibitors and risk of adverse drug reactions using the Japanese medical database.
Region	Japan

Condition
Condition	drug-induced renal dysfunction
Classification by specialty	Medicine in general Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Using a Japanese population database, the purpose of this study is to examine whether the dose and duration of PPI use increases the risk of developing or progressing to renal dysfunction and other adverse effects compared to those not taking PPIs or those using other acid suppression treatments (H2 blockers).
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	chronic kidney disease
Key secondary outcomes	Adverse events such as acute interstitial nephritis (AIN), Clostridioides difficile enteritis Changes in the onset of adverse effects with the type and dose of PPIs and H2 blockers Changes in the incidence of adverse effects in each group by propensity score matching

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients started on regular prescriptions (more than 1 month) for PPIs or H2 blockers
Key exclusion criteria	Patients diagnosed with an adverse effect disease within 1 year prior to the index date when they started taking PPIs and H2 blockers
Target sample size	0

Research contact person
Name of lead principal investigator	1st name Tatsuya Middle name Last name Yagi
Organization	Hamamatsu University School of Medicine
Division name	Department of Hospital pharmacy
Zip code	431-3192
Address	1-20-1 Handayama, Hamamatsu, Shizuoka, Japan
TEL	053-435-2767
Email	yagi5922@hama-med.ac.jp

Public contact
Name of contact person	1st name Hironari Middle name Last name Tanaka
Organization	Hamamatsu University School of Medicine
Division name	Department of Hospital pharmacy
Zip code	431-3192
Address	1-20-1 Handayama, Hamamatsu, Shizuoka, Japan
TEL	053-435-2767
Homepage URL
Email	htanaka@hama-med.ac.jp

Sponsor
Institute	Department of Hospital pharmacy Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization	Department of Hospital pharmacy Hamamatsu University School of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	University of Shizuoka
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethics Committee of Clinical Research
Address	1-20-1 Handayama, Hamamatsu, Shizuoka, Japan
Tel	053-435-2680
Email	rinri@hama-med.ac.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	2022 Year 05 Month 17 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	Preinitiation
Date of protocol fixation	2021 Year 11 Month 15 Day
Date of IRB	2022 Year 01 Month 11 Day
Anticipated trial start date	2022 Year 01 Month 11 Day
Last follow-up date	2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	A cohort study using a Japanese database No formal sample size calculation was conducted for the present study due to the nature of database study.

Management information
Registered date	2022 Year 05 Month 16 Day
Last modified on	2022 Year 05 Month 16 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054453