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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000029682
Receipt No. R000033921
Scientific Title Association between copper-containing enzyme, ceruloplasmin, and anemia in chronic kidney disease, erythropoietin low responsiveness of the hemodialysis patient
Date of disclosure of the study information 2017/10/24
Last modified on 2019/05/13

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Basic information
Public title Association between copper-containing enzyme, ceruloplasmin, and anemia in chronic kidney disease, erythropoietin low responsiveness of the hemodialysis patient
Acronym Association between ceruloplasmin and erythropoietin low responsiveness
Scientific Title Association between copper-containing enzyme, ceruloplasmin, and anemia in chronic kidney disease, erythropoietin low responsiveness of the hemodialysis patient
Scientific Title:Acronym Association between ceruloplasmin and erythropoietin low responsiveness
Region
Japan

Condition
Condition Anemia in chronic kidney disease
Classification by specialty
Medicine in general Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To analyze the association between serum Ceruloplasmin and ESA low responsiveness transversely
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Hb concentrations and this change.
Key secondary outcomes ESA dose and this change.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
100 years-old >=
Gender Male and Female
Key inclusion criteria After maintenance haemodialysis induction, continuing ESA, agreement by the free will from the person obtained about participation in this study
Key exclusion criteria (1) It is the patient with the plan of the renal transplant within 24 weeks after registration
(2) At registration, it is the patient with a malignant tumor, blood disorder or the clear hemorrhagic lesion
(3) A pregnant woman, nursing mother, the patients who may be pregnant or the patients who hope for pregnancy in a research organization
(4) The patients who participate in a trial
(5) In addition, the patients who judged that a study responsibility physician or the study medical attendant was inappropriate
Target sample size 150

Research contact person
Name of lead principal investigator
1st name Ichiei
Middle name
Last name Narita
Organization Niigata University Graduate School of Medical and Dental Sciences
Division name Division of Clinical Nephrology and Rheumatology
Zip code 9518510
Address 1-757, Asahimachi-dori, Niigata
TEL 0252272200
Email naritai@med.niigata-u.ac.jp

Public contact
Name of contact person
1st name Yuichi
Middle name
Last name Sakamaki
Organization Tachikawa Genaral Hospital
Division name Nephlorogy
Zip code 9408621
Address 561-1, Kamijomachi-Taniuchi, Nagaoka, Niigata
TEL 0258-33-3111
Homepage URL
Email sakamaki@med.niigata-u.ac.jp

Sponsor
Institute Tachikawa Hospital
Institute
Department

Funding Source
Organization Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Tachikawa Sogo Hospital
Address Nagaoka, Niigata, Japan
Tel 0258333111
Email ysakamaki-dm@umin.net

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
2017 Year 10 Month 24 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
2017 Year 09 Month 18 Day
Date of IRB
Anticipated trial start date
2017 Year 10 Month 23 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Crossing study using 3-month data

Management information
Registered date
2017 Year 10 Month 24 Day
Last modified on
2019 Year 05 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033921

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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