UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056049 |
|---|---|
| Receipt number | R000064049 |
| Scientific Title | The specified drug use result surveillance of darbepoetin alfa, study on anemia associated with myelodysplastic syndromes |
| Date of disclosure of the study information | 2024/11/05 |
| Last modified on | 2024/11/05 13:27:42 |
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Basic information
Public title
The specified drug use result surveillance of darbepoetin alfa, study on anemia associated with myelodysplastic syndromes
Acronym
The specified drug use result surveillance of darbepoetin alfa
Scientific Title
The specified drug use result surveillance of darbepoetin alfa, study on anemia associated with myelodysplastic syndromes
Scientific Title:Acronym
The specified drug use result surveillance of darbepoetin alfa
Region
| Japan |
Condition
Condition
Anemia associated with myelodysplastic syndromes
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of darbepoetin alfa in long-term daily practice.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Safety
(1) Occurrence of ADRs and infection
(2) Evaluation on factors likely to affect safety
(3) Occurrence of unknown ADRs
(4) Occurrence of serious AEs
(5) Occurrence of priority survey items (effect on transition to AML and life prognosis)
2. Efficacy
(1) Overall improvement level (by attending physicians)
(2) Changes in Hb level
(3) Evaluation on factors likely to affect efficacy
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
Patients who have anemia associated with myelodysplastic syndromes and were treated with darbepoetin alfa.
Key exclusion criteria
None
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Kuwazawa |
Organization
Kyowa Kirin Co.,Ltd.
Division name
Pharmacovigilance division
Zip code
100-0004
Address
1-9-2 Ohtemachi, Chiyoda-ku, Tokyo
TEL
03-5205-7200
hiroshi.kuwazawa.wd@kyowakirin.com
Public contact
Name of contact person
| 1st name | Yukie |
| Middle name | |
| Last name | Tsuji |
Organization
Kyowa Kirin Co.,Ltd.
Division name
Pharmacovigilance division
Zip code
100-0004
Address
1-9-2 Ohtemachi, Chiyoda-ku, Tokyo
TEL
03-5205-7200
Homepage URL
yukie.tsuji.dq@kyowakirin.com
Sponsor or person
Institute
Kyowa Kirin Co.,Ltd.
Institute
Department
Personal name
Funding Source
Organization
Kyowa Kirin Co.,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethical Review Committee of Kyowa Kirin Co., Ltd
Address
1-9-2, Otemachi, Chiyoda-ku, Tokyo
Tel
03-5205-7200
researchethics.fj@kyowakirin.com
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
| 2024 | Year | 11 | Month | 05 | 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
2091
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
| 2014 | Year | 12 | Month | 24 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 30 | Day |
Anticipated trial start date
| 2015 | Year | 02 | Month | 09 | Day |
Last follow-up date
| 2024 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2024 | Year | 11 | Month | 05 | Day |
Last modified on
| 2024 | Year | 11 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064049
