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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000032613
Receipt No. R000037184
Scientific Title Retrospective study to investigate background factors affecting occurrence of nephrotoxicity and recovery from the nephrotoxicity on L-AMB using Electric Medical Data
Date of disclosure of the study information 2018/06/01
Last modified on 2020/05/19

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Basic information
Public title Retrospective study to investigate background factors affecting occurrence of nephrotoxicity and recovery from the nephrotoxicity on L-AMB using Electric Medical Data
Acronym Retrospective study to investigate background factors affecting occurrence of nephrotoxicity and recovery from the nephrotoxicity on L-AMB using Electric Medical Data
Scientific Title Retrospective study to investigate background factors affecting occurrence of nephrotoxicity and recovery from the nephrotoxicity on L-AMB using Electric Medical Data
Scientific Title:Acronym Retrospective study to investigate background factors affecting occurrence of nephrotoxicity and recovery from the nephrotoxicity on L-AMB using Electric Medical Data
Region
Japan

Condition
Condition Nephrotoxicity
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The main objective of this study is to analyze data on L-AMB administration, occurrence of side effects and treatment effects and others, and to provide useful evidence when healthcare professionals administer L-AMB in clinical sites
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To investigate background factors affecting occurrence of nephrotoxicity and recovery from the nephrotoxicity on L-AMB.
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Over 18 years old at the initial L-AMB administration
Have received L-AMB administration at least once
Serum creatinine is measured at least twice as follows
once on the start date of L-AMB administration or within 7days before the initial L-AMB administration
once on the last date of L-AMB administration or within 7 days after last of L-AMB administration
Key exclusion criteria Total L-AMB dose administration of per day for per 1kg of body weight has ever exceeded 6mg (titer) during L-AM administration period
Target sample size 600

Research contact person
Name of lead principal investigator
1st name KOICHI
Middle name
Last name IZUMIKAWA
Organization Nagasaki University Graduate School of Biomedical Sciences
Division name Department of INFECTIOUS DISEASES
Zip code 852-8501
Address International Medical Center - Nagasaki University Hospital 852-8501 1-7-1 Sakamoto ,Nagasaki
TEL 095-819-7184
Email koizumik@nagasaki-u.ac.jp

Public contact
Name of contact person
1st name MASATO
Middle name
Last name TASHIRO
Organization Nagasaki University Graduate School of Biomedical Sciences
Division name Department of INFECTIOUS DISEASES
Zip code 852-8501
Address International Medical Center - Nagasaki University Hospital 852-8501 1-7-1 Sakamoto ,Nagasaki
TEL 095-819-7184
Homepage URL
Email mtashiro@nagasaki-u.ac.jp

Sponsor
Institute Nagasaki University
Institute
Department

Funding Source
Organization Sumitomo Dainippon Pharma Co., Ltd
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Deloitte Tohmatsu Consulting LLC
Name of secondary funder(s)

IRB Contact (For public release)
Organization Nagasaki University Graduate School of Biomedical Sciences
Address 1-12-4 Sakamoto Nagasaki 852-8523, JAPAN
Tel 095-819-7195
Email gakujutu_kikaku@ml.nagasaki-u.ac.jp

Secondary IDs
Secondary IDs YES
Study ID_1 18033038
Org. issuing International ID_1 Nagasaki University
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2018 Year 06 Month 01 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 Main results already published
Date of protocol fixation
2018 Year 03 Month 30 Day
Date of IRB
2018 Year 04 Month 18 Day
Anticipated trial start date
2018 Year 06 Month 01 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Exploratory evaluation is conducted with multiple regression analysis method to investigate factors affecting occurrence of nephropathy and recovery from nephrotoxicity. The items selected by clinicians from the following items are investigated for target Patients
1 Patient information
2 Hematological examination
3 Blood Biochemistry Examination
4 Serum diagnosis
5 L-AMB(Date of administration, dosage, and total L-AMB dose administration)
6 The status of intractable disease

Management information
Registered date
2018 Year 05 Month 16 Day
Last modified on
2020 Year 05 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037184

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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