UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033555 |
|---|---|
| Receipt number | R000038047 |
| Scientific Title | Estimation of dose determination method for erythropoiesis-stimulating agents |
| Date of disclosure of the study information | 2018/07/31 |
| Last modified on | 2020/07/31 12:42:49 |
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Basic information
Public title
Estimation of dose determination method for erythropoiesis-stimulating agents
Acronym
Estimation of dose determination method for erythropoiesis-stimulating agents
Scientific Title
Estimation of dose determination method for erythropoiesis-stimulating agents
Scientific Title:Acronym
Estimation of dose determination method for erythropoiesis-stimulating agents
Region
| Japan |
Condition
Condition
Renal anemia
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Estimation of dose determination method for erythropoiesis-stimulating agents
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Hemoglobin levels stability
Key secondary outcomes
Dose and efficiency of erythropoiesis-stimulating agents
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Renal anemia treatments continuously using dose determination method for erythropoiesis-stimulating agents.
Duration: Six months.
Interventions/Control_2
Usual renal anemia treatments not using dose determination method for erythropoiesis-stimulating agents.
Duration: Six months.
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
Hemodialysis duration: 3 months or more.
Erythropoiesis-stimulating agents treatments: 3 months or more.
Key exclusion criteria
Severe heart failure
Uncontrolled Hypertension
Non-renal anemia
Bleeding needing blood transfusion within 3 months.
Major surgery within 6 months.
CRP levels of 3 mg/L or more.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Tetsuya |
| Middle name | |
| Last name | Fujikawa |
Organization
Yokohama National University
Division name
Center for health service sciences
Zip code
240-8501
Address
Tokiwadai 79-8, Hodogaya-ku, Yokohama city.
TEL
0453393153
tftf@ynu.ac.jp
Public contact
Name of contact person
| 1st name | Tetsuya |
| Middle name | |
| Last name | Fujikawa |
Organization
Yokohama national university
Division name
Center for health service sciences
Zip code
240-8501
Address
Tokiwadai 79-8, Hodogaya-ku, Yokohama city.
TEL
0453393153
Homepage URL
tftf@ynu.ac.jp
Sponsor or person
Institute
Yokodai central clinic
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Yokohama National University
Address
Tokiwadai 79-5, Hodogaya-ku, Yokohama city.
Tel
0453393192
kenkyu.somu@ynu.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
| 2018 | Year | 07 | Month | 31 | 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 | 02 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 25 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 07 | Month | 30 | Day |
Last modified on
| 2020 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038047
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
