Tokyo, Nov. 28 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059899) titled 'Research aimed at elucidating the pathophysiology of the cardiovascular-kidney-metabolic syndrome using single-cell and spatial transcriptomic analysis' on Nov. 27.
Study Type:
Observational
Primary Sponsor:
Institute - the University of Tokyo
Condition:
Condition - Chronic kidney disease and cardiovascular-kidney-metabolic syndrome
Classification by malignancy - Others
Genomic information - YES
Objective:
Narrative objectives1 - In this study, single-cell and spatial transcriptomic analyses of human kidney and vascular specimens collected at our institution, as well as proteomic analyses of chronic kidney disease (CKD), will be conducted. These data will then be integrated with information from the J-Kidney-Biobank, a biobank for CKD, to elucidate the pathophysiology of CKM syndrome, and to identify novel biomarkers and therapeutic targets.
Basic objectives2 - Others
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Participants in this study shall be individuals who meet all of the following criteria:
Aged 18 years or older
No restriction on sex
Meeting at least one of the following conditions:
Studies using kidney specimens:
Patients who, on or after January 1, 2020, required renal biopsy or living-donor kidney transplantation as part of routine clinical care, or who have already undergone renal biopsy or living-donor kidney transplantation. In cases of living-donor kidney transplantation, donors will also be included.
Studies using vascular specimens:
Patients who, on or after January 1, 2020, required arteriovenous fistula creation or synthetic vascular graft implantation as part of routine clinical care, or who have already undergone these procedures.
Studies using plasma specimens:
Patients who are enrolled in the J-Kidney-Biobank and whose plasma samples have been banked in the biobank.
Key exclusion criteria - Individuals meeting any of the following conditions will not be included in this study:
Cases in which the investigator determines that participation is undesirable, such as when there is a risk of compromising data reliability.
Cases involving kidney transplantation performed using deceased donors rather than living donors.
Individuals who have expressed refusal for their information to be used in this study.
Individuals who lack the capacity to provide informed consent.
Cases in which no specimens are available for analysis, for example, when no residual samples remain beyond those required for routine clinical care.
Target Size - 150
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 11 Month 26 Day
Date of IRB - 2025 Year 11 Month 26 Day
Anticipated trial start date - 2025 Year 11 Month 28 Day
Last follow-up date - 2029 Year 09 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068504
Disclaimer: Curated by HT Syndication.