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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000046049
Receipt No. 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 2021/11/11

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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
Obsterics 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
Email 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
Email takeshi.n.900113@gmail.com

Sponsor
Institute Jikei university school of medicine
Institute
Department

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
Email 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 Preinitiation
Date of protocol fixation
2021 Year 11 Month 01 Day
Date of IRB
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
2021 Year 11 Month 11 Day


Link to view the page
URL(English) 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
Registered date File name

Research case data
Registered date File name


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