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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009253
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Juntendo University School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010864

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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