UMIN-CTR Clinical Trial

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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