UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016552 |
|---|---|
| Receipt number | R000018835 |
| Scientific Title | The influence of administration of epoetin beta pegol (CERA) and saccharated ferric oxide on erythroferron and hepcidin of hemodialyzed patients |
| Date of disclosure of the study information | 2015/02/25 |
| Last modified on | 2015/02/16 15:20:56 |
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Basic information
Public title
The influence of administration of epoetin beta pegol (CERA) and saccharated ferric oxide on erythroferron and hepcidin of hemodialyzed patients
Acronym
CERA and erythroferron, hepcidin
Scientific Title
The influence of administration of epoetin beta pegol (CERA) and saccharated ferric oxide on erythroferron and hepcidin of hemodialyzed patients
Scientific Title:Acronym
CERA and erythroferron, hepcidin
Region
| Japan |
Condition
Condition
Hemodialyzed patients with renal anemia
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the influence of renal anemia treatment on iron metabolism
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Erythropoiesis: Hb, reticulocytes, CHr
Iron metabolism: serum iron, UIBC, ferritin, erythroferron et al.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Intravenous administration of iron
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Maintenance hemodialyzed patients who are administrated erythropoiesis stimulating agents
Key exclusion criteria
Inflammation, iron excess, malignancy and gastro-intestinal, hepatic, and bone marrow diseases
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Nakanishi |
Organization
Hyogo College of Medicine
Division name
Dep Internal Medicine, Div Kidney and Dialysis
Zip code
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo
TEL
0798-45-6521
jin@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yukiko Hasuike |
Organization
Hyogo College of Medicine
Division name
Dep Internal Medicine, Div Kidney and Dialysis
Zip code
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo
TEL
0798456521
Homepage URL
jin@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo College of Medicine
Institute
Department
Personal name
Funding Source
Organization
No source
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
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
甲南病院（神戸市）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 02 | Month | 25 | 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
Preinitiation
Date of protocol fixation
| 2015 | Year | 01 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 02 | Month | 25 | 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
| 2015 | Year | 02 | Month | 16 | Day |
Last modified on
| 2015 | Year | 02 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018835
| 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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