UMIN-CTR Clinical Trial

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
Last 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
1st 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/icdr_e/ctr_view.cgi?recptno=R000033921