UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009253 |
|---|---|
| Receipt number | R000010864 |
| Scientific Title | Safety and efficacy of the epoetin kappa on anemia and inflammation in hemodialysis patients |
| Date of disclosure of the study information | 2012/11/15 |
| Last modified on | 2014/05/07 17:53:58 |
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Basic information
Public title
Safety and efficacy of the epoetin kappa on anemia and inflammation in hemodialysis patients
Acronym
EpoKappa study
Scientific Title
Safety and efficacy of the epoetin kappa on anemia and inflammation in hemodialysis patients
Scientific Title:Acronym
EpoKappa study
Region
| Japan |
Condition
Condition
Nephrogenic anemia patients undergoing hemodialysis
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Nephrogenic anemia patients on hemodialysis who had been taking epoetin alpha or epoetin beta were switched to Epoetin Kappa to confirm that the latter was safe and had an anemia-improving effect equivalent to the previous medication, as well as to investigate changes in blood erythropoietin concentration, iron metabolism, and inflammatory cytokines and their causal relationship to the study drug.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Hb concentration,serum erythropoietin level,iron-related indices:serum iron,serum ferritin concentration,IBC(iron binding capacity),TSAT(transferrin saturation),inflammatory markers:PTX3,CRP,TNFa,IL6
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Epoetin Kappa (Genetical Recombination)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Hemodialysis patients using epoetin alpha or epoetin beta
2. Patients who have given written informed consent to participate in this study (consent of patient himself)
Key exclusion criteria
1. Patients for whom Epoetin Kappa is contraindicated
2. Patient deemed by investigator to be unsuitable for participation in this study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuhiko Tomino |
Organization
Juntendo University School of Medicine
Division name
Department of Nephrology
Zip code
Address
Hongo2-1-1, Bunkyo-ku, Toky
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Chieko Hamada |
Organization
Juntendo University School of Medicine
Division name
Department of Nephrology
Zip code
Address
TEL
03-5802-1065
Homepage URL
Sponsor or person
Institute
Juntendo University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
no
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 11 | Month | 15 | 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
| 2012 | Year | 08 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 11 | Month | 02 | Day |
Last modified on
| 2014 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010864
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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