UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061178 |
|---|---|
| Receipt number | R000069832 |
| Scientific Title | Elucidation of the Molecular Basis of Life-to-Death Transition: A Prospective Observational Study to Identify Biological Responses of Life Maintenance and Revitalization |
| Date of disclosure of the study information | 2026/04/07 |
| Last modified on | 2026/04/07 09:59:10 |
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Basic information
Public title
Elucidation of the Molecular Basis of Life-to-Death Transition: A Prospective Observational Study to Identify Biological Responses of Life Maintenance and Revitalization
Acronym
X-Life Study
Scientific Title
Elucidation of the Molecular Basis of Life-to-Death Transition: A Prospective Observational Study to Identify Biological Responses of Life Maintenance and Revitalization
Scientific Title:Acronym
X-Life Study
Region
| Japan |
Condition
Condition
Heart disease, Kidney disease, Malignant neoplasm, and Infectious disease
Classification by specialty
| Cardiology | Nephrology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the molecular basis of the "Life Extension System," which encompasses biological responses involved in the recovery, resuscitation, and maintenance of life.
Basic objectives2
Others
Basic objectives -Others
Exploratory research
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
All-cause mortality
Key secondary outcomes
Cause of mortality (e.g., cardiovascular death, renal death, infectious death, cancer-related death, and others)
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 currently hospitalized at the Department of Cardiology/Nephrology, Nara Medical University Hospital, Nanwa Hospital, or Nishinokyo Hospital who have a medical history of any of the following conditions.
Acute death model: Patients with severe acute heart failure, cardiogenic shock, fatal arrhythmia requiring mechanical circulatory support, or those in the terminal stage due to the progression of irreversible and fatal diseases.
Slow death model: High-risk patients undergoing maintenance dialysis, patients requiring emergency initiation of dialysis, patients with chronic kidney disease complicated by severe infection, or patients with end-stage kidney disease who have opted for conservative kidney management.
Key exclusion criteria
Patients judged by the investigator to be unsuitable as subjects.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiko |
| Middle name | |
| Last name | Tsuruya |
Organization
Nara medical university hospital
Division name
Department of nephrology
Zip code
634-8522
Address
840 Shijocho, Kashihara, Nara, Japan
TEL
0744-22-3051
tsuruya@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Eriguchi |
Organization
Nara medical university hospital
Division name
Department of nephrology
Zip code
634-8522
Address
840 Shijocho, Kashihara, Nara, Japan
TEL
0744-22-3051
Homepage URL
meriguci@naramed-u.ac.jp
Sponsor or person
Institute
Nara medical university hospital
Institute
Department
Personal name
Funding Source
Organization
Acquisition, Technology, and Logistics Agency (ATLA) Type S.
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nara Medical University Ethics Committee
Address
840 Shijocho, Kashihara, Nara, Japan
Tel
0744-22-3051
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
奈良県立医科大学附属病院（奈良県）、Karydo TherapeutiX株式会社（京都府）、医療法人弘仁会南和病院（奈良県）、医療法人康人会西の京病院（奈良県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | Month | 07 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 17 | Day |
Last follow-up date
| 2031 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
prospective cohort study
Management information
Registered date
| 2026 | Year | 04 | Month | 07 | Day |
Last modified on
| 2026 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069832
