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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000015041
Receipt No. R000017464
Scientific Title Examination about Hb cycling and the C.E.R.A. given dose in the C.E.R.A. 1-time medication per week in hemodialysis patients
Date of disclosure of the study information 2014/09/03
Last modified on 2017/09/05

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Basic information
Public title Examination about Hb cycling and the C.E.R.A. given dose in the C.E.R.A. 1-time medication per week in hemodialysis patients
Acronym Effect of weekly C.E.R.A.
Scientific Title Examination about Hb cycling and the C.E.R.A. given dose in the C.E.R.A. 1-time medication per week in hemodialysis patients
Scientific Title:Acronym Effect of weekly C.E.R.A.
Region
Japan

Condition
Condition chronic renak failure
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The decrease of the C.E.R.A. total given dose for four weeks by medication once per week
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Decrease of C.E.R.A. total given dose
Key secondary outcomes Decrease of blood Hepcidin concentration

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 Change to the 1-time C.E.R.A.medication per week
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
85 years-old >=
Gender Male and Female
Key inclusion criteria undergoing three times dialysis per week three months or more
Key exclusion criteria woman under pregnancy and breast-feeding, myocardial infarction, pulmonary infarction, and cerebral infarction
malignant tumor, serious illness infection, blood dyscrasia, hemolytic anemia, or gastrointestinal bleeding
beyond AST100 IU/L or beyond ALT100 U/L
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiyuki Oshiro
Organization Kawasaki Medical School
Division name Department of General Internal Medicine 1
Zip code
Address 2-1-80, Nakasange, Kita-ku Okayama, Japan
TEL 086-225-2111
Email y-oshiro@med.kawasaki-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshiyuki Oshiro
Organization Kawasaki Medical School
Division name Department of General Internal Medicine 1
Zip code
Address 2-6-1, Nakasange, Kita-ku Okayama, Japan
TEL 086-225-2111
Homepage URL
Email y-oshiro@med.kawasaki-m.ac.jp

Sponsor
Institute Department of General Internal Medicine 1 Kawasaki Medical School
Institute
Department

Funding Source
Organization Department of General Internal Medicine 1 Kawasaki Medical School
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Nozatomon Clinic
Name of secondary funder(s) non

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 野里門クリニック(兵庫県)

Other administrative information
Date of disclosure of the study information
2014 Year 09 Month 03 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 Enrolling by invitation
Date of protocol fixation
2015 Year 03 Month 27 Day
Date of IRB
Anticipated trial start date
2015 Year 08 Month 01 Day
Last follow-up date
2017 Year 03 Month 31 Day
Date of closure to data entry
2017 Year 06 Month 30 Day
Date trial data considered complete
2017 Year 07 Month 30 Day
Date analysis concluded
2017 Year 12 Month 30 Day

Other
Other related information

Management information
Registered date
2014 Year 09 Month 03 Day
Last modified on
2017 Year 09 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017464

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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