UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019305 |
|---|---|
| Receipt number | R000022326 |
| Scientific Title | Dynamics of iron status in chronic hemodialysis patients -measurement of iron loss and periodic supplementation- |
| Date of disclosure of the study information | 2015/10/09 |
| Last modified on | 2016/11/06 18:25:57 |
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Basic information
Public title
Dynamics of iron status in chronic hemodialysis patients
-measurement of iron loss and periodic supplementation-
Acronym
Dynamics of iron status in chronic hemodialysis patients
Scientific Title
Dynamics of iron status in chronic hemodialysis patients
-measurement of iron loss and periodic supplementation-
Scientific Title:Acronym
Dynamics of iron status in chronic hemodialysis patients
Region
| Japan |
Condition
Condition
chronic hemodialysis patients
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Safety and efficacy of iron supplementation equivalent to
iron loss by hemodialysis procedure
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
annual iron status
Key secondary outcomes
hemoglobin, serum iron, transferrin satulation rate, ferritin, dose of erythropoiesis stumulating agent
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
periodic iron supplementation for one year
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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
chronic hemodialysis patients
Key exclusion criteria
1) active malignancy, hematological disorder, iron looser by gastro-intestinal bleeding, etc.
2) allergy against ESA
3) pregnant or considering pregnanct woman, lactating woman
4) patients attending other clinical trials
5) improper patien
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tatsuo Tsukamoto |
Organization
Kyoto University Hospital
Division name
Department of nephrology
Zip code
Address
54 Shogoin-Kawahara-cho, Sakyo-ku, Kyoto
TEL
+81-75-751-3860
ttsukamo@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tatsuo Tsukamoto |
Organization
Kyoto University Hospital
Division name
Department of nephrology
Zip code
Address
54 Shogoin-Kawahara-cho, Sakyo-ku, Kyoto
TEL
+81-75-751-3860
Homepage URL
ttsukamo@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Deaprtment of nephrology, Kyoto University Hospital
Institute
Department
Personal name
Funding Source
Organization
Deaprtment of nephrology, Kyoto University 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
洛和会音羽記念病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 10 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Annual iron loss by hemodialysis is around 500mg in Japan. (Am J Nephrol. 2016;43(1):32-8)
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
| 2015 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2017 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2017 | Year | 05 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 10 | Month | 09 | Day |
Last modified on
| 2016 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022326
| 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 |
