UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032613 |
|---|---|
| Receipt number | 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 09:19:24 |
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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
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
mtashiro@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037184
