UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029682 |
|---|---|
| Receipt number | 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 12:03:05 |
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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
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
sakamaki@med.niigata-u.ac.jp
Sponsor or person
Institute
Tachikawa Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033921
