UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047756 |
|---|---|
| Receipt number | 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 | 2023/06/21 14:50:37 |
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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
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
midori.tateyama@milliman.com
Sponsor or person
Institute
Milliman Inc.
Institute
Department
Personal name
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
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
N/A
Publication of results
Published
Result
URL related to results and publications
https://www.tandfonline.com/doi/full/10.1080/13696998.2022.2158661
Number of participants that the trial has enrolled
3127
Results
The utilities decreased with higher pain (-0.189 for pain level of 3.05), longer time for the IV infusion (-0.145 or -0.212 for 5 or 15 min), greater number of required IV infusions (-0.773 or -1.899 for 3 or 25 times), and higher frequency of adverse events (-0.373 or -0.385 for 13.0% or 14.2% of hypophosphatemia incidences; -0.502 for 2.3% of skin discoloration per one infusion).
Results date posted
| 2023 | Year | 06 | Month | 21 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
1. Patients with iron-deficiency anemia who have received IV iron treatment: 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: Patients who have been diagnosed as iron-deficiency anemia by doctors.
3. General population (20-69 years old): 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.
Participant flow
Randomly selected via an online panel managed by INTAGE Inc.
Adverse events
N/A
Outcome measures
Preference for factors about intravenous (IV) iron infusion: waiting time before receiving IV infusion, pain due to IV infusion, time equired 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
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2023 | Year | 06 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054216
