Unique ID issued by UMIN | UMIN000017252 |
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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 |
Long-term usage of darbepoetin alpha in non-dialysis CKD patients
DREAM-J
Long-term usage of darbepoetin alpha in non-dialysis CKD patients
DREAM-J
Japan |
Non-dialysis CKD
Nephrology | Urology |
Others
NO
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
Safety
ADR status / incidence
Observational
Not applicable |
Not applicable |
Male and Female
Non-dialysis CKD patients who have the first time using darbepoetin alpha for renal anemia
Patients who are supposed to have dialysis or kidney transplant within 6-month
3000
1st name | |
Middle name | |
Last name | Tsuyoshi Nishitoba |
Kyowa Hakko Kirin Co., Ltd.
Pharmacovigilance and Quality Assurance Division Pharmacovigilance Department
1-6-1, Ohtemachi, Chiyoda-ku, Tokyo, Japan
03-3282-0063
tsuyoshi.nishitoba@kyowa-kirin.co.jp
1st name | |
Middle name | |
Last name | Satoru Itou |
Kyowa Hakko Kirin Co., Ltd.
Pharmacovigilance and Quality Assurance Division Pharmacovigilance Department
1-6-1, Ohtemachi, Chiyoda-ku, Tokyo, Japan
03-3282-0063
Satoru.itou@kyowa-kirin.co.jp
Kyowa Hakko Kirin Co., Ltd.
Kyowa Hakko Kirin Co., Ltd.
Profit organization
NO
2015 | Year | 04 | Month | 23 | Day |
Partially published
Completed
2010 | Year | 06 | Month | 15 | Day |
2010 | Year | 08 | Month | 26 | Day |
2014 | Year | 12 | Month | 16 | Day |
2016 | Year | 04 | Month | 25 | Day |
2016 | Year | 04 | Month | 25 | Day |
2016 | Year | 06 | Month | 20 | Day |
prospective surveillance
2015 | Year | 04 | Month | 23 | Day |
2016 | Year | 08 | Month | 10 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020023
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