UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046049 |
|---|---|
| Receipt number | R000052560 |
| Scientific Title | Efficacy and safety of Ferric carboxymaltose injection compared with oral iron for the treatment of postpartum anemia in Japan: a randomized controlled clinical trial |
| Date of disclosure of the study information | 2021/12/01 |
| Last modified on | 2023/05/14 16:05:08 |
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Basic information
Public title
Efficacy and safety of Ferric carboxymaltose injection compared with oral iron for the treatment of postpartum anemia in Japan: a randomized controlled clinical trial
Acronym
Efficacy and safety of Ferric carboxymaltose injection compared with oral iron for the treatment of postpartum anemia in Japan: a randomized controlled clinical trial
Scientific Title
Efficacy and safety of Ferric carboxymaltose injection compared with oral iron for the treatment of postpartum anemia in Japan: a randomized controlled clinical trial
Scientific Title:Acronym
Efficacy and safety of Ferric carboxymaltose injection compared with oral iron for the treatment of postpartum anemia in Japan: a randomized controlled clinical trial
Region
| Japan |
Condition
Condition
postpartum anemia
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the efficacy and safety of Ferric carboxymaltose injection compared with oral iron for the treatment of postpartum anemia.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in Hb level after 2 weeks of treatment
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Ferric carboxymaltose injection 500mg twice every two weeks.
Interventions/Control_2
Dried Ferrous Sulfate 210mg per day for 4 weeks
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
| Not applicable |
Gender
Female
Key inclusion criteria
Patients with Hb less than 10g/dL and ferritin less than 500 ng/mL after vaginal delivery or cesarean section. Patients weighing 35 kg or more
Key exclusion criteria
1) Patients whose CRP level measured exceeds 20 mg/L
(2) Patients with hematological diseases
(3) Patients with serious hepatic disorder, renal disorder, or cardiovascular disease
4) Persons who have received a blood transfusion within 1 week
(5) Patients with malignant tumors
(6) Patients with a history of serious drug allergy such as anaphylactic shock or a history of serious adverse drug reactions.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Nagao |
Organization
Jikei university school of medicine
Division name
Division of obstetrics and gynecology
Zip code
105-8471
Address
3-19-18, Nishishinbashi, Minatoku, Tokyo
TEL
03-3433-1111
takeshi.n.900113@gmail.com
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Nagao |
Organization
Jikei university school of medicine
Division name
Division of obstetrics and gynecology
Zip code
105-8471
Address
3-19-18, Nishishinbashi, Minatoku, Tokyo
TEL
03-3433-1111
Homepage URL
takeshi.n.900113@gmail.com
Sponsor or person
Institute
Jikei university school of medicine
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Jikei university school of medicine Institutional Review Board
Address
3-19-18, Nishishinbashi, Minatoku, Tokyo
Tel
03-3433-1111
takeshi.n.900113@gmail.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
| 2021 | Year | 12 | Month | 01 | 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
Completed
Date of protocol fixation
| 2021 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 24 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 11 | Month | 11 | Day |
Last modified on
| 2023 | Year | 05 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052560
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
