UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003427 |
|---|---|
| Receipt number | R000004150 |
| Scientific Title | Clinical assessment of serum hepcidin isoforms associated with iron homeostasis and erythropoiesis-stimulating agent response in CKD patients |
| Date of disclosure of the study information | 2010/04/01 |
| Last modified on | 2019/11/22 08:47:10 |
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Basic information
Public title
Clinical assessment of serum hepcidin isoforms associated with iron homeostasis and erythropoiesis-stimulating agent response in CKD patients
Acronym
Clinical assessment of serum hepcidin isoforms associated with iron homeostasis and erythropoiesis-stimulating agent response in CKD patients
Scientific Title
Clinical assessment of serum hepcidin isoforms associated with iron homeostasis and erythropoiesis-stimulating agent response in CKD patients
Scientific Title:Acronym
Clinical assessment of serum hepcidin isoforms associated with iron homeostasis and erythropoiesis-stimulating agent response in CKD patients
Region
| Japan |
Condition
Condition
CKD
Classification by specialty
| Hematology and clinical oncology | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the association of serum hepcidin, iron-related biomarker, erythropoitic activity and cytokine, and to asses erythropoiesis-stimulating agent response in CKD patients
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The relationship between the change of serum hepcidin and the responsiveness to erythropoiesis-stimulating agent
Key secondary outcomes
To evaluate the association of serum hepcidin, iron-related biomarker, erythropoitic activity and serum cytokine
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The enrolled patients who have been diagnosed as CKD.
Key exclusion criteria
These patients were excluded with severe inflammatory disease, infection, cancer, hematological disorders or blood transfusion within 4 weeks.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhito Takeda |
Organization
Iizuka Hospital
Division name
The department of nephrology
Zip code
Address
Yoshiomachi 3-83,Iizuka,Fukuoka,Japan
TEL
0948-22-3800
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Kimura |
Organization
Iizuka Hospital
Division name
The department of nephrology
Zip code
Address
Yoshiomachi 3-83,Iizuka,Fukuoka,Japan
TEL
0948-22-3800
Homepage URL
hkimurah2@aih-net.com
Sponsor or person
Institute
iizuka Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
1) Kamakura Research Laboratory of Chugai Pharmaceutical CO., LTD.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
飯塚病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 04 | Month | 01 | 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
| 2008 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2008 | Year | 07 | Month | 21 | Day |
Anticipated trial start date
| 2008 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2014 | Year | 06 | Month | 01 | Day |
Other
Other related information
Blood samples for whole blood and serum parameters were obtained at the start of the study and would be obtained in the next 3, 6, 12, 24 months time.
Management information
Registered date
| 2010 | Year | 04 | Month | 01 | Day |
Last modified on
| 2019 | Year | 11 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004150
