UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012910 |
|---|---|
| Receipt number | R000015093 |
| Scientific Title | A study to evalute iron metabolism by hepcidin-25 in patients on hemodialysis treated with epoetin beta pegol once-monthly or twice--monthly |
| Date of disclosure of the study information | 2014/01/21 |
| Last modified on | 2014/01/21 15:31:04 |
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Basic information
Public title
A study to evalute iron metabolism by hepcidin-25 in patients on hemodialysis treated with epoetin beta pegol once-monthly or twice--monthly
Acronym
A study to evalute iron metabolism by hepcidin-25 in patients on hemodialysis treated with epoetin beta pegol once-monthly or twice--monthly
Scientific Title
A study to evalute iron metabolism by hepcidin-25 in patients on hemodialysis treated with epoetin beta pegol once-monthly or twice--monthly
Scientific Title:Acronym
A study to evalute iron metabolism by hepcidin-25 in patients on hemodialysis treated with epoetin beta pegol once-monthly or twice--monthly
Region
| Japan |
Condition
Condition
Renal anemia on hemodialysis patients
Classification by specialty
| Medicine in general | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
evaluate iron metabolism by hepcidin-25 in patients on hemodialysis treated with epoetin beta pegol once-monthly or twice-monthly injection
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
(1) biological parameters of iron metabolism(including Hep-25)
(2) ERI(ESA Resistance Index) at endpoint
(3) pecentage of maintaing the target Hb level for one year
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
treated epoetin beta pegol once-monthly for one year
Interventions/Control_2
treated epoetin beta pegol twice-monthly for one year
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 who receive three times a week of hemodialysis more than three months
2.patients treated with 50-200 CERA per month
3.patients who hemoglobin density of 3 months undergoes a change of at 10-12 g/dL in the past
4.patients that clear iron lack is not accepted in the past three months
(Ferritin over 50 ng/mL)
5.20 years old or older
6.patients who acccept this study
Key exclusion criteria
1.patients who do not accept this study
2.patients who have allergy for ESA
3.patients who have uncontrollable high blood pressure
4.patients with factors that could have a clear impact on hemoglobin
concentration, such as infectious
diseases, malignant tumors, bleeding of moderate or more
5.women who are pregnant,breastfeeding,possibly pregnant,or not willing to use birth control in the period leading up to the end of the study at the time of obtaining informed consent
6.patients who received red bllod cell transfusion within 3 months before enrollment
7.patients who are judged ineligible by the physician in charge
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | naohisa tomosugi |
Organization
kanazawa medical university medical research institute
Division name
Division of Aging Research
Zip code
Address
daigaku1-1 uchinadamachi kahokugun Ishikawa,Japan
TEL
076-286-2211
shogo-k@kanazawa-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shogo Kimura |
Organization
Chuno Kosei Hospital
Division name
Division of Nephrology
Zip code
Address
5-1Wakakusadoori,Seki-city,Gifu
TEL
0575-22-2211
Homepage URL
shogo-k@kanazawa-med.ac.jp
Sponsor or person
Institute
kanazawa medical university medical research institute,Division of Aging Research
Institute
Department
Personal name
Funding Source
Organization
kanazawa medical university medical research institute,Division of Aging Research
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Chuno Kosei Hospital Division of Nephrology
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
| 2014 | Year | 01 | Month | 21 | 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
No longer recruiting
Date of protocol fixation
| 2013 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | Month | 01 | 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
| 2014 | Year | 01 | Month | 21 | Day |
Last modified on
| 2014 | Year | 01 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015093
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
