UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012572 |
|---|---|
| Receipt number | R000014709 |
| Scientific Title | Iron status affect platelet counts in hemodialysis patients. |
| Date of disclosure of the study information | 2013/12/14 |
| Last modified on | 2015/06/14 12:20:59 |
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Basic information
Public title
Iron status affect platelet counts in hemodialysis patients.
Acronym
Iron status affect platelet counts in hemodialysis patients.
Scientific Title
Iron status affect platelet counts in hemodialysis patients.
Scientific Title:Acronym
Iron status affect platelet counts in hemodialysis patients.
Region
| Japan |
Condition
Condition
End stage renal failure on maintenance heamodialysis.
Classification by specialty
| Nephrology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigated the association between platelet counts and iron reactivity among HD patients.
Basic objectives2
Others
Basic objectives -Others
We examined whether iron depletion was associated with thrombocytosis. Does platelet counts correlate with iron indices? Does platelet counts trends and variability correlate with iron indices? We investigated whether ESAs doses was associated with iron reactivity.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
platelet counts, serum iron, ferritin, transferrin saturation
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
Cohort study of HD outpatients followed from 2002 to 2012.
Key exclusion criteria
Exclude hospital patients and data during hospitalization.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kiyomi Koike |
Organization
Kurume University School of Medicine
Division name
Division of Nephrology, Department of Medicine
Zip code
Address
67 Asahi-machi, Kurume 830-0011 Japan
TEL
0942-35-3311
koike_kiyomi@kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kiyomi Koike |
Organization
Kurume University School of Medicine
Division name
Division of Nephrology, Department of Medicine
Zip code
Address
67 Asahi-machi, Kurume 830-0011 Japan
TEL
0942-35-3311
Homepage URL
koike_kiyomi@kurume-u.ac.jp
Sponsor or person
Institute
Kurume University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kurume University School of Medicine
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
久留米大学病院
島松内科医院
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 12 | Month | 14 | 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
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
Main results already published
Date of protocol fixation
| 2009 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
| 2014 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
| 2014 | Year | 12 | Month | 31 | Day |
Other
Other related information
This study is retrospective cohort study.Therapy targets for renal anemia were Hb11.0 g/dL and ferritin 200 mg/dL with erythropoietin and protocol for i.v. iron supplementation. We investigate the association between iron indices and increase in platelet counts with mixed effect model with non-linear and linear analysis used regular checkup data.
Management information
Registered date
| 2013 | Year | 12 | Month | 13 | Day |
Last modified on
| 2015 | Year | 06 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014709
