UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017366 |
|---|---|
| Receipt number | R000020152 |
| Scientific Title | Comparison of iron supplementation methods for hemodialysis patients |
| Date of disclosure of the study information | 2015/05/01 |
| Last modified on | 2018/05/31 12:26:25 |
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Basic information
Public title
Comparison of iron supplementation methods for hemodialysis patients
Acronym
Comparison of iron supplementation methods for hemodialysis patients
Scientific Title
Comparison of iron supplementation methods for hemodialysis patients
Scientific Title:Acronym
Comparison of iron supplementation methods for hemodialysis patients
Region
| Japan |
Condition
Condition
end-stage kidney disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the efficacy and safety of intravenous and oral iron supplementation in hemodialysis patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in hemoglobin values of before and after the iron supplementation and the frequency of side effect by iron supplementation
Key secondary outcomes
Changes in values of serum iron, transferrin saturation, ferritin, and the amount of administered erythropoiesis-stimulating agents
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Intravenous administration of 40mg of saccharated ferric oxide once a week after hemodialysis
Interventions/Control_2
Oral administration of 50-100mg of sodium ferrous citrate per day
Interventions/Control_3
Ferric citrate hydrate group: oral administration of 500-2250mg of ferric citrate hydrate per day irrespective of iron deficiency [In this group, only patients with hyperphosphatemia (serum phosphate >6.0mg/dL) are registered.]
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
Hemodialysis patients complicated with iron deficiency (transferrin saturation < 20% and ferritin < 100 ng/mL) or hyperphosphatemia
Key exclusion criteria
Patients complicated with potential diseases causing anemia such as hemorrhagic disease, hematological disease, or carcinoma
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Michio Kuwahara |
Organization
Shuuwa General Hospital
Division name
Department of Nephrology
Zip code
Address
1200 Yahara-Shinden, Kasukabe, Saitama 344-0035, Japan
TEL
048-737-2121
kuwaharam@shuuwa-gh.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Michio Kuwahara |
Organization
Shuuwa General Hospital
Division name
Department of Nephrology
Zip code
Address
1200 Yahara-Shinden, Kasukabe, Saitama 344-0035, Japan
TEL
048-737-2121
Homepage URL
kuwaharam@shuuwa-gh.or.jp
Sponsor or person
Institute
Shuuwa General Hospital
Institute
Department
Personal name
Funding Source
Organization
Shuuwa General Hospital
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
Address
Tel
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
| 2015 | Year | 05 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 10 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 11 | Month | 04 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This research had been planned and promoted by Michio Kuwahara (MK). However, MK was transferred to work in April 2017, and MK currently work for another hospital.
MK wss unable to find a researcher who will take over this research. Therefore, MK had to abandon the continuation of this research.
Management information
Registered date
| 2015 | Year | 05 | Month | 01 | Day |
Last modified on
| 2018 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020152
| 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 |
