UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Long-term usage of darbepoetin alpha in non-dialysis CKD patients
Title of the study (Brief title)	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	Tsuyoshi Nishitoba
Organization	Kyowa Hakko Kirin Co., Ltd.
Division name	Pharmacovigilance and Quality Assurance Division Pharmacovigilance Department
Address	1-6-1, Ohtemachi, Chiyoda-ku, Tokyo, Japan
TEL	03-3282-0063
Email	tsuyoshi.nishitoba@kyowa-kirin.co.jp

Public contact
Name of contact person	Satoru Itou
Organization	Kyowa Hakko Kirin Co., Ltd.
Division name	Pharmacovigilance and Quality Assurance Division Pharmacovigilance Department
Address	1-6-1, Ohtemachi, Chiyoda-ku, Tokyo, Japan
TEL	03-3282-0063
Homepage URL
Email	Satoru.itou@kyowa-kirin.co.jp

Sponsor
Institute	Kyowa Hakko Kirin Co., Ltd.
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 06 Month 15 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020023