UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010084 |
|---|---|
| Receipt number | R000011797 |
| Scientific Title | Effect of iron supplementation on erythropoiesis and iron-related parameters in hemodialysis patients receiving epoetin beta pegol: a randomized controlled study |
| Date of disclosure of the study information | 2013/02/20 |
| Last modified on | 2017/07/31 11:50:33 |
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Basic information
Public title
Effect of iron supplementation on erythropoiesis and iron-related parameters in hemodialysis patients receiving epoetin beta pegol: a randomized controlled study
Acronym
Erythropoiesis efficacy of epoetin beta pegol and timing of iron supplementation
Scientific Title
Effect of iron supplementation on erythropoiesis and iron-related parameters in hemodialysis patients receiving epoetin beta pegol: a randomized controlled study
Scientific Title:Acronym
Erythropoiesis efficacy of epoetin beta pegol and timing of iron supplementation
Region
| Japan |
Condition
Condition
Patients treated with maintenance hemodialysis
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effect of iron supplementation on epoetin beta pegol efficacy
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 epoetin beta pegol
(4)Hemodynamic parameters
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
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Iron supplementation within 2 weeks of epoetin beta pegol administration
Interventions/Control_2
Iron supplementation after 2 weeks of epoetin beta pegol administration
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
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tetsuya Fujikawa |
Organization
Yokohama City University Graduate School of Medicine
Division name
Department of Medical Science and Cardiorenal Medicine
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama city, Japan
TEL
045-787-2635
tftf@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tetsuya Fujikawa |
Organization
Yokohama City University Graduate School of Medicine
Division name
Department of Medical Science and Cardiorenal Medicine
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama city, Japan
TEL
045-787-2635
Homepage URL
tftf@yokohama-cu.ac.jp
Sponsor or person
Institute
Department of Medical Science and Cardiorenal Medicine, Yokohama City University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Medical Science and Cardiorenal Medicine, Yokohama City University Graduate School of Medicine
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
横浜市立大学附属病院(神奈川県)、朋進会透析クリニック(神奈川県)
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 02 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2012 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 02 | Month | 20 | 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
| 2013 | Year | 02 | Month | 20 | 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=R000011797
