UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026308 |
|---|---|
| Receipt number | R000030211 |
| Scientific Title | Effect of monthly administration of 40mg saccharated ferric oxide on hemoglobin variability and erythropoiesis resistance index in patients with hemodialysis |
| Date of disclosure of the study information | 2021/03/31 |
| Last modified on | 2024/03/09 12:57:22 |
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Basic information
Public title
Effect of monthly administration of 40mg saccharated ferric oxide on hemoglobin variability and erythropoiesis resistance index in patients with hemodialysis
Acronym
Hb variability and ERI by monthly administration of iron in HD patients
Scientific Title
Effect of monthly administration of 40mg saccharated ferric oxide on hemoglobin variability and erythropoiesis resistance index in patients with hemodialysis
Scientific Title:Acronym
Hb variability and ERI by monthly administration of iron in HD patients
Region
| Japan |
Condition
Condition
end stage renal disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Stabilization of iron status and erythropoietin resistance index by monthly administration of 40mg saccharated ferric oxide
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Hemoglobin variability
Key secondary outcomes
1)erythropoiesis resistance index
2)Iron deficiency
3)iron exccess
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
monthly iron administration
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Clinically stable HD patients with renal anemia more than 1 year
2.Written informed consent was obtained
Key exclusion criteria
1. Iron deficiency
2. Vitamin B12 and/or folate deficiency
3. Unstable iron metabolism
4. Drug allergy
5. Written informed consent was not obtained
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Tatsuo |
| Middle name | |
| Last name | Tsukamoto |
Organization
Kitano Hospital, The Tazuke Kofukai Medical Research Institute
Division name
Neohrology & Dialysis
Zip code
530-8480
Address
2-4-20 Ohgimachi, Kita-ku, Osaka
TEL
06-6312-8824
t-tsukamoto@kitano-hp.or.jp
Public contact
Name of contact person
| 1st name | Tatsuo |
| Middle name | |
| Last name | Tsukamoto |
Organization
Kitano Hospital, The Tazuke Kofukai Medical Research Institute
Division name
Neohrology & Dialysis
Zip code
530-8480
Address
2-4-20 Ohgimachi, Kita-ku, Osaka
TEL
06-6312-8824
Homepage URL
t-tsukamoto@kitano-hp.or.jp
Sponsor or person
Institute
Kitano Hospital, The Tazuke Kofukai Medical Research Institute
Institute
Department
Personal name
Funding Source
Organization
Kitano Hospital, The Tazuke Kofukai Medical Research Institute
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kitano Hospital, Tazuke Kofukai Medical Research Institute
Address
2-4-20 Ohgimachi, Kita-ku, Osaka
Tel
0663121221
rinshou@kitano-hp.or.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
| 2021 | Year | 03 | Month | 31 | 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
60
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
incomplete data management
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
| 2017 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 15 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 02 | Month | 25 | Day |
Last modified on
| 2024 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030211
| 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 |
