UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017252 |
|---|---|
| Receipt number | R000020023 |
| Scientific Title | Long-term usage of darbepoetin alpha in non-dialysis CKD patients |
| Date of disclosure of the study information | 2015/04/23 |
| Last modified on | 2016/08/10 16:18:52 |
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Basic information
Public title
Long-term usage of darbepoetin alpha in non-dialysis CKD patients
Acronym
DREAM-J
Scientific Title
Long-term usage of darbepoetin alpha in non-dialysis CKD patients
Scientific Title:Acronym
DREAM-J
Region
| Japan |
Condition
Condition
Non-dialysis CKD
Classification by specialty
| Nephrology | Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Confirmation of Efficacy and safety for darbepoetin alpha as follow;
(1)Detection of the unexpected Adverse drug reaction (ADR)s
(2)Confirmation of ADR status / incidence
(3)Identification and confirmation of factors which affect safety and efficacy
(4)Special surveillance items
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
ADR status / incidence
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Non-dialysis CKD patients who have the first time using darbepoetin alpha for renal anemia
Key exclusion criteria
Patients who are supposed to have dialysis or kidney transplant within 6-month
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tsuyoshi Nishitoba |
Organization
Kyowa Hakko Kirin Co., Ltd.
Division name
Pharmacovigilance and Quality Assurance Division Pharmacovigilance Department
Zip code
Address
1-6-1, Ohtemachi, Chiyoda-ku, Tokyo, Japan
TEL
03-3282-0063
tsuyoshi.nishitoba@kyowa-kirin.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoru Itou |
Organization
Kyowa Hakko Kirin Co., Ltd.
Division name
Pharmacovigilance and Quality Assurance Division Pharmacovigilance Department
Zip code
Address
1-6-1, Ohtemachi, Chiyoda-ku, Tokyo, Japan
TEL
03-3282-0063
Homepage URL
Satoru.itou@kyowa-kirin.co.jp
Sponsor or person
Institute
Kyowa Hakko Kirin Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Kyowa Hakko Kirin Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
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
| 2015 | Year | 04 | Month | 23 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2010 | Year | 06 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 08 | Month | 26 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 16 | Day |
Date of closure to data entry
| 2016 | Year | 04 | Month | 25 | Day |
Date trial data considered complete
| 2016 | Year | 04 | Month | 25 | Day |
Date analysis concluded
| 2016 | Year | 06 | Month | 20 | Day |
Other
Other related information
prospective surveillance
Management information
Registered date
| 2015 | Year | 04 | Month | 23 | Day |
Last modified on
| 2016 | Year | 08 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020023
| 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 |
