UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005068 |
|---|---|
| Receipt number | R000006025 |
| Scientific Title | The effect of Darbepoetin for renal anemia and iron kinetics in Chronic Kidney Disease(CKD) patients |
| Date of disclosure of the study information | 2011/02/10 |
| Last modified on | 2014/04/04 11:14:02 |
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Basic information
Public title
The effect of Darbepoetin for renal anemia and iron kinetics in Chronic Kidney Disease(CKD) patients
Acronym
The effect of Darbepoetin for renal anemia and iron kinetics in Chronic Kidney Disease(CKD) patients
Scientific Title
The effect of Darbepoetin for renal anemia and iron kinetics in Chronic Kidney Disease(CKD) patients
Scientific Title:Acronym
The effect of Darbepoetin for renal anemia and iron kinetics in Chronic Kidney Disease(CKD) patients
Region
| Japan |
Condition
Condition
Chronic kidney disease and renal anemia
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The effect of Darbepoetin for renal anemia in CKD patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The mean hemoglobin(Hb) change and the achievement rate of Hb target concentration
Key secondary outcomes
Iron kinetics
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Epoetin
Interventions/Control_2
Darbepoetin
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
The concentration of Hb is under 11.0mg/dl in CKD patients
Key exclusion criteria
severe heart failure
impossible control of hypertension and so on
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takayasu Ito |
Organization
Yamamoto General Hospital
Division name
Internal Medicine
Zip code
Address
3-11 Kotobuki-cho Kuwana city Mie prefecture
TEL
059221211
takayassu@msn.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takayasu Ito |
Organization
Yamamoto general hospital
Division name
Internal Medicine
Zip code
Address
3-11 Kotobuki-cho Kuwana city Mie prefecture
TEL
0594221211
Homepage URL
takayassu@msn.com
Sponsor or person
Institute
Yamamoto General Hospital
Institute
Department
Personal name
Funding Source
Organization
Yamamoto General Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 02 | Month | 10 | 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
Terminated
Date of protocol fixation
| 2010 | Year | 02 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2012 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2012 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 02 | Month | 10 | Day |
Last modified on
| 2014 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006025
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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