UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026276 |
|---|---|
| Receipt number | R000030174 |
| Scientific Title | The relationship between variability of iron-related parameters under iron supplementation and prognosis in hemodialysis patients with renal anemia |
| Date of disclosure of the study information | 2017/02/23 |
| Last modified on | 2020/08/27 12:51:53 |
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Basic information
Public title
The relationship between variability of iron-related parameters under iron supplementation and prognosis in hemodialysis patients with renal anemia
Acronym
The relationship between variability of iron-related parameters under iron supplementation and prognosis in hemodialysis patients with renal anemia
Scientific Title
The relationship between variability of iron-related parameters under iron supplementation and prognosis in hemodialysis patients with renal anemia
Scientific Title:Acronym
The relationship between variability of iron-related parameters under iron supplementation and prognosis in hemodialysis patients with renal anemia
Region
| Japan |
Condition
Condition
end stage renal disease
Classification by specialty
| Cardiology | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will investigate that relationship between iron-related parameters and prognosis in hemodialysis patients.
Basic objectives2
Others
Basic objectives -Others
(1) Blood cell examination
(2) Blood chemical examination including iron-related, inflammation, nutrition indexes
(3) Hemodynamic parameters
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Death and its reason in five years.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Patients with maintenance hemodialysis
(2) Patients with renal anemia, who are treated with rHuEPO and iron
Key exclusion criteria
Severe congestive heart failure
Uncontrolled hypertension
Malignancy
Major surgery within the previous 6 months
Active bleeding, need for erythrocyte transfusion within 12 weeks before the study
Systemic inflammatory disease and/or C-reactive protein levels >3 mg/dL
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tetsuya Fujikawa |
Organization
Yokohama National University
Division name
Center for Health Service Sciences
Zip code
Address
79-8 Tokiwa-dai, Hodogaya-ku, Yokohama city, Japan.
TEL
045-339-3153
tftf@ynu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tetsuya Fujikawa |
Organization
Yokohama National University
Division name
Center for Health Service Sciences
Zip code
Address
79-8 Tokiwa-dai, Hodogaya-ku, Yokohama city, Jap
TEL
045-339-3153
Homepage URL
tftf@ynu.ac.jp
Sponsor or person
Institute
Yokodai Central Clinic
Institute
Department
Personal name
Funding Source
Organization
Yokodai Central Clinic
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2017 | Year | 02 | Month | 23 | 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
Completed
Date of protocol fixation
| 2016 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 09 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective cohort study
Management information
Registered date
| 2017 | Year | 02 | Month | 23 | Day |
Last modified on
| 2020 | Year | 08 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030174
