UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009449 |
|---|---|
| Receipt number | R000011080 |
| Scientific Title | Effect of epoetin beta pegol treatment on renal anemia and blood pressure control in non-dialytic CKD patients |
| Date of disclosure of the study information | 2013/01/01 |
| Last modified on | 2018/09/05 11:29:04 |
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Basic information
Public title
Effect of epoetin beta pegol treatment on renal anemia and blood pressure control in non-dialytic CKD patients
Acronym
Effect of epoetin beta pegol on renal anemia and blood pressure in non-dialytic CKD patients
Scientific Title
Effect of epoetin beta pegol treatment on renal anemia and blood pressure control in non-dialytic CKD patients
Scientific Title:Acronym
Effect of epoetin beta pegol on renal anemia and blood pressure in non-dialytic CKD patients
Region
| Japan |
Condition
Condition
non-dyalitic chronic kidney disease (CKD)
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify effect of epoetin beta pegol injection on blood Hb level and mean blood pressure as well as its fluctuation during outpatient clinic in non-dialytic patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Blood Hb level before and after epoetin beta pegol treatment and mean blood pressure as well as its fluctuation during outpatient clinic.
Key secondary outcomes
Correlation between blood pressure fluctuation and incidence of cardiovascular events before and after epoetin beta pegol treatment.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Epoetin beta pegol injection to treat renal anemia
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
1. Chronic kidney disease stage 4 and 5, non-dialytic
2. Hb level lower than 11g/dl
3. Longer than 6 months of therapeutic period estimated until initiation of dialysis
4. Volantary consent obtained after adequate explanation on the study
Key exclusion criteria
1. Allergic to erythropoiesis stimulating agents (ESA)
2. Either malignant diseases, severe infectious diseases, or significant adverse conditions complicated
3. Other inadequate occasions assessed by the attending physician
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenichiro Asano |
Organization
Kurashiki Central Hospital
Division name
Nephrology
Zip code
Address
1-1-1 Miwa Kurashiki-city Okayama 710-8602 Japan
TEL
086-422-0210
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenichiro Asano |
Organization
Kurashiki Central Hospital
Division name
Nephrology
Zip code
Address
1-1-1 Miwa Kurashiki-city Okayama 710-8602 Japan
TEL
086-422-0210
Homepage URL
http://kchsps1/SiteDirectory/d3750/SitePages/Home.aspx
ka11734@kchnet.or.jp
Sponsor or person
Institute
Kurashiki Central Hospital
Institute
Department
Personal name
Funding Source
Organization
Kurashiki Central 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
倉敷中央病院 Kurashiki Central Hospital
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 01 | 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
| 2013 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 01 | Month | 11 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 12 | Month | 01 | Day |
Last modified on
| 2018 | Year | 09 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011080
| 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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| Registered date | File name |
