UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020700 |
|---|---|
| Receipt number | R000023886 |
| Scientific Title | Quantitative evaluation for effect of iron supplementation therapy on erythropoiesis efficiency in hemodialysis patients treated with rHuEPO |
| Date of disclosure of the study information | 2016/01/22 |
| Last modified on | 2017/07/31 11:52:46 |
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Basic information
Public title
Quantitative evaluation for effect of iron supplementation therapy on erythropoiesis efficiency in hemodialysis patients treated with rHuEPO
Acronym
Low dose iron supplementation therapy and rHuEPO erythropoiesis efficiency
Scientific Title
Quantitative evaluation for effect of iron supplementation therapy on erythropoiesis efficiency in hemodialysis patients treated with rHuEPO
Scientific Title:Acronym
Low dose iron supplementation therapy and rHuEPO erythropoiesis efficiency
Region
| Japan |
Condition
Condition
Maintenance hemodialysis/ Renal anemia
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effect of low dose iron supplementation on rHuEPO efficiency
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
(1) Hemoglobin and erythropoiesis-related indexes
(2)Blood chemical examination including iron-related, inflammation, nutrition indexes
(3)Required dose of rHuEPO
(4)Hemodynamic parameters
(1)-(4): Two-month after the start of iron administration.
Key secondary outcomes
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
Low dose iron supplementation
(Fesin 20mg/week for 2 months)
Interventions/Control_2
Standard iron supplementation
(Fesin 40mg/week for 2 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
(1) Patients with maintenance hemodialysis
(2) Patients with renal anemia, who are treated with rHuEPO or iron
Key exclusion criteria
(1) Patients with chronic inflammation, malignant disorder, severe congestive heart failure, respiratory organs, and liver disorder
(2) Patients who are receiving dialysis modalities other than hemodialysis
Target sample size
100
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 Tokiwadai, 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 Tokiwadai, Hodogaya-ku, Yokohama city, Japan.
TEL
045-339-3153
Homepage URL
tftf@ynu.ac.jp
Sponsor or person
Institute
Yokohama National University
Institute
Department
Personal name
Funding Source
Organization
The Kidney Foundation, Japan (JKFB15-17)
Organization
Division
Category of Funding Organization
Non profit foundation
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
| 2016 | Year | 01 | Month | 22 | 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
| 2014 | Year | 12 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | Month | 22 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 01 | Month | 22 | Day |
Last modified on
| 2017 | 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=R000023886
