UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054530 |
|---|---|
| Receipt number | R000054951 |
| Scientific Title | Search for the erythropoiesis-stimulating agents (ESAs) responsiveness and prognostic biomarkers in patients on hemodialysis |
| Date of disclosure of the study information | 2024/05/31 |
| Last modified on | 2024/05/31 14:34:15 |
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Basic information
Public title
Search for the erythropoiesis-stimulating agents (ESAs) responsiveness and prognostic biomarkers in patients on hemodialysis
Acronym
Search for the erythropoiesis-stimulating agents (ESAs) responsiveness and prognostic biomarkers in patients on hemodialysis
Scientific Title
Search for the erythropoiesis-stimulating agents (ESAs) responsiveness and prognostic biomarkers in patients on hemodialysis
Scientific Title:Acronym
Search for the erythropoiesis-stimulating agents (ESAs) responsiveness and prognostic biomarkers in patients on hemodialysis
Region
| Japan |
Condition
Condition
Chronic kidney disease
End stage kidney disease (ESKD)
Classification by specialty
| Medicine in general | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify whether serum hepcidin and proteins involved in the progression of end-stage renal disease (ESKD-related proteins) can be predictive indicators of cardiovascular events in patients on hemodialysis. Also, We will clarify whether serum hepcidin and ESKD-related proteins can be used to evaluate ESA hyporesponsiveness.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
In patients on hemodialysis, hazard ratio and odds ratio of the baseline hepcidin and ESKD related protein concentration for the onset of future cardiovascular events.
Key secondary outcomes
Optimal cutoff value, sensitivity, specificity, positive predictive value, negative predictive value for cardiovascular events.
Optimal cutoff value for blood hepcidin and ESKD-related protein levels in ESA hyporesponsiveness.
Sensitivity, specificity, positive predictive value, negative predictive value in the diagnosis of ESA hyporesponsiveness.
Comparison of diagnostic ability of blood hepcidin concentration and erythropoietin resistance index (ERI).
Rate of change in hepcidin and ESKD-related proteins before and after administration of ESAs.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients on hemodialysis
Patients over 20 years old
Patients who agreed to participate in the study
Key exclusion criteria
Patients who refused to participate in this study. Patients judged by the principal investigator to be inappropriate as research subjects.
Target sample size
1200
Research contact person
Name of lead principal investigator
| 1st name | Masanori |
| Middle name | |
| Last name | Abe |
Organization
Nihon University Itabashi Hospital
Division name
Internal medicine, division of Nephrology, Hypertension and Endocrinology
Zip code
1738610
Address
30-1, Oyaguchikamicho, Itabashi-ku, Tokyo 173-8610
TEL
03-3972-8111
maruyama.takashi@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Maruyama |
Organization
Nihon University Itabashi Hospital
Division name
Internal medicine, division of Nephrology, Hypertension and Endocrinology
Zip code
173-8610
Address
30-1, Oyaguchikamicho, Itabashi-ku, Tokyo 173-8610
TEL
0339728111
Homepage URL
maruyama.takashi@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University Itabashi Hospital
Institute
Department
Personal name
Funding Source
Organization
FUJIFILM Wako Pure Chemical
Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Akabanechuo hospital fuzoku Clinic
Shikiekimae Clinic. Asakadaitoseki Clinic
Yujin Clinic. Yujinoizumigakuen Clinic. YujinKamishakujii Clinic. Toshima chou Hospital. Ishin Clinic.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nihon University Itabashi Hospital Institutional Review Board, Certified Clinical Research Review Board
Address
30-1, Oyaguchikamicho, Itabashi-ku, Tokyo 173-8610
Tel
0339728111
med.itabashi.clinicalresearch@nihon-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
日本大学医学部附属板橋病院
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 05 | 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
900
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 02 | Month | 02 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 30 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The study is ongoing. We are following the onset of events.
Management information
Registered date
| 2024 | Year | 05 | Month | 31 | Day |
Last modified on
| 2024 | 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=R000054951
