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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000047756
Receipt No. R000054216
Scientific Title Estimation of preference and monetary value of intravenous iron infusion for patients with iron deficiency anemia
Date of disclosure of the study information 2022/05/16
Last modified on 2022/05/23

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Basic information
Public title Estimation of preference and monetary value of intravenous iron infusion for patients with iron deficiency anemia
Acronym Estimation of preference and monetary value of intravenous iron infusion for patients with iron deficiency anemia
Scientific Title Estimation of preference and monetary value of intravenous iron infusion for patients with iron deficiency anemia
Scientific Title:Acronym Estimation of preference and monetary value of intravenous iron infusion for patients with iron deficiency anemia
Region
Japan

Condition
Condition iron deficiency anemia
Classification by specialty
Medicine in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To estimate preference and monetary cost for factors of convenience about intravenous (IV) iron infusion in patients with iron deficiency anemia
Basic objectives2 Others
Basic objectives -Others Preference
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Preference for factors about intravenous (IV) iron infusion: waiting time before receiving IV infusion, pain due to IV infusion, time required for the IV infusion (excluding follow-up time after the treatment), number of IV infusions required to achieve treatment effect, frequency of hypophosphatemia as a side effect after the IV infusion, frequency of deposition of the drug solution on the skin, and out-of-pocket cost for 1 IV infusion


Key secondary outcomes

Base
Study type Others,meta-analysis etc

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
20 years-old <=
Age-upper limit
79 years-old >=
Gender Male and Female
Key inclusion criteria 1. Patients with iron-deficiency anemia who have received IV iron treatment (1000 patients): Patients who have received IV iron treatment for iron-deficiency anemia in the past.
2. Patients with iron-deficiency anemia other than those in 1 (1000 patients): Patients who have been diagnosed as iron-deficiency anemia by doctors.
3. General population (20-69 years old, 1000 people): General people who are not included in 1 or 2. Note: iron-deficiency anemia patients will be included at the same rate as that of anemia patients in Japan. They will be collected according to the proportion of Japanese population by age group.
Key exclusion criteria Patients/people who stop responding to the survey (not considered as respondents).
Target sample size 3000

Research contact person
Name of lead principal investigator
1st name Tomomi
Middle name
Last name Takeshima
Organization Milliman Inc.
Division name Japan Healthcare Practice & Data Analytics
Zip code 102-0083
Address Kojimachi 1-chome Building 8F, 1-6-2 Kojimachi, Chiyoda-ku, Tokyo, Japan
TEL 03-5211-7031
Email tomomi.takeshima@mmilliman.com

Public contact
Name of contact person
1st name Midori
Middle name
Last name Tateyama
Organization Milliman Inc.
Division name Japan Healthcare Practice & Data Analytics
Zip code 102-0083
Address Kojimachi 1-chome Building 8F, 1-6-2 Kojimachi, Chiyoda-ku, Tokyo, Japan
TEL 03-5211-7031
Homepage URL
Email midori.tateyama@milliman.com

Sponsor
Institute Milliman Inc.
Institute
Department

Funding Source
Organization Nippon Shinyaku 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 RIHDS Ethical Review Board
Address 12th Floor, Suitomo Shiba Daimon Building, 2-5-5 Shiba Daimon, Minato-ku, Tokyo, Japan
Tel 03-5733-5010
Email rihds@jmdc.co.jp

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
2022 Year 05 Month 16 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 No longer recruiting
Date of protocol fixation
2022 Year 04 Month 28 Day
Date of IRB
2022 Year 05 Month 11 Day
Anticipated trial start date
2022 Year 05 Month 19 Day
Last follow-up date
2022 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information A questionnaire survey will be performed for the eligible people in research panel in a research company.
The results of survey will be analyzed by conjoint analysis.

Management information
Registered date
2022 Year 05 Month 14 Day
Last modified on
2022 Year 05 Month 23 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054216

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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