UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053794 |
|---|---|
| Receipt number | R000061397 |
| Scientific Title | The association of total iron binding capacity (TIBC) with prognosis in hemodialysis patients stratified by nutritional status or chronic inflammatory status |
| Date of disclosure of the study information | 2024/03/07 |
| Last modified on | 2025/09/08 11:44:16 |
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Basic information
Public title
The association of total iron binding capacity (TIBC) with prognosis in hemodialysis patients stratified by nutritional status or chronic inflammatory status
Acronym
TIBC and prognosis in HD patients stratified by nutritional and inflammatory status
Scientific Title
The association of total iron binding capacity (TIBC) with prognosis in hemodialysis patients stratified by nutritional status or chronic inflammatory status
Scientific Title:Acronym
TIBC and prognosis in HD patients stratified by nutritional and inflammatory status
Region
| Japan |
Condition
Condition
End-stage kidney disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the prognostic value of TIBC in chronic maintenance hemodialysis patients, stratified by the presence or absence of malnutrition and chronic inflammatory conditions.
Basic objectives2
Others
Basic objectives -Others
all-cause mortality, thrombotic complications or cardiovascular disease
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
all-cause mortality
Key secondary outcomes
Death or hospitalization for thrombotic complications or cardiovascular disease
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients undergoing outpatient dialysis at Japanese dialysis facilities included in Japan-Dialysis Outcomes and Practice Patterns Study (J-DOPPS) 4th to 7th term
Key exclusion criteria
Patients received blood purification therapy other than hemodialysis
Patients received home hemodialysis
Patients with acute kidney injury
Missing for TIBC at baseline
Target sample size
5000
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Eriguchi |
Organization
Nara Medical University
Division name
Department of Nephrology
Zip code
634-8521
Address
840 Shijocho, Kashihara, Nara
TEL
0744298865
meriguci@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Eriguchi |
Organization
Nara Medical University
Division name
Department of Nephrology
Zip code
634-8521
Address
840 Shijocho, Kashihara, Nara
TEL
0744298865
Homepage URL
meriguci@naramed-u.ac.jp
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
Masahiro Eriguchi
Funding Source
Organization
Nara Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Institute for Health Outcomes and Process Evaluation research
Name of secondary funder(s)
Astellas Pharma
IRB Contact (For public release)
Organization
Medical Research Ethics Committee in Nara Medical University
Address
840 Shijocho, Kashihara, Nara, 634-8521, Japan
Tel
0744223051
ino_rinri@naramed-u.ac.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
| 2024 | Year | 03 | Month | 07 | 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
5604
Results
In the crude model, mortality risk decreased progressively with higher TIBC quintiles in patients with hypoalbuminemia or elevated CRP (trend P = 0.003 and P < 0.0001), but not in those with preserved albumin or low CRP. However, spline analysis indicated increased mortality above 300 ug/dL of TIBC, with similar associations for cardiovascular and thrombotic events, but only in the presence of hypoalbuminemia or inflammation.
Results date posted
| 2025 | Year | 09 | Month | 08 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
For addittional analyses
Date of the first journal publication of results
Baseline Characteristics
A total of 8,552 patients participated in J-DOPPS phases 4-7. After excluding those who were missing TIBC at baseline and those with no effective follow-up observations, 5,604 patients were included in the statistical analyses.
Baseline characteristics of the subjects for analysis and those stratified by TIBC quintile subgroups are summarized in Table 1. When considering SMD > 0.2 as a guideline, the group with lower TIBC tended to have older age, lower BMI, more cardiovascular disease, lower hemoglobin, lower serum albumin, lower serum phosphorus, and higher CRP. Regarding markers related to iron metabolism, they had high transferrin saturation and high serum ferritin. Among anemia-related drug prescriptions, the proportion of ESA prescriptions was high.
Participant flow
The Japan Dialysis Outcomes and Practice Patterns Study (J-DOPPS) is a prospective cohort study conducted in Japan as part of the international Dialysis Outcomes and Practice Patterns Study (DOPPS). The study population consisted of adult hemodialysis outpatients randomly selected from representative samples drawn from hemodialysis facilities in Japan. For the present analysis, we used data from J-DOPPS Phases 4, 5, 6, and 7 databases (2009 to 2012, 2012 to 2015, 2015 to 2018, and 2018 to 2021, respectively).
Adverse events
N/A
Outcome measures
The primary outcome was all-cause mortality. The secondary outcomes were cardiovascular events and thrombotic events.
For secondary outcomes, a cardiovascular event was defined as the first occurrence after baseline of death or hospitalization due to cardiovascular disease (CVD). CVD as a cause of death or hospitalization included: acute myocardial infarction (AMI); pericarditis including cardiac tamponade; ischemic heart disease (excluding AMI); cardiomyopathy; arrhythmia; sudden cardiac arrest; valvular heart disease; pulmonary edema due to fluid retention; congestive heart failure; hemorrhagic stroke; ischemic stroke; transient ischemic attack; coronary angioplasty; and coronary artery bypass grafting (CABG).
A thrombotic event was defined as the first occurrence after baseline of death or hospitalization due to thrombotic disease. Thrombotic diseases included: AMI; ischemic heart disease (excluding AMI); pulmonary embolism; ischemic stroke; mesenteric infarction/intestinal ischemia; angina pectoris; transient ischemic attack; intermittent claudication/rest pain; limb ulcers; gangrene; deep vein thrombosis; coronary angioplasty; CABG; peripheral artery bypass surgery; limb amputation; and excision of gangrenous tissue.
Plan to share IPD
N/A
IPD sharing Plan description
N/A
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2024 | Year | 03 | Month | 07 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 05 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 07 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 07 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is an observational study that uses the dataset of an existing prospective observational study.
Management information
Registered date
| 2024 | Year | 03 | Month | 07 | Day |
Last modified on
| 2025 | Year | 09 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061397
