![]() |
UMIN-CTR Clinical Trial |
|
![]() |
![]() |
![]() |
![]() |
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 |
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 |
|
Condition | ||
Condition | iron deficiency anemia | |
Classification by specialty |
|
|
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 |
|
|||
Age-upper limit |
|
|||
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 |
|
||||||
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 |
|
||||||
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 | |
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 |
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 |
|
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 |
|
||||||
Date of IRB |
|
||||||
Anticipated trial start date |
|
||||||
Last follow-up date |
|
||||||
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 |
|
||||||
Last modified on |
|
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 |