Status:
RECRUITING
A Mixed Cohort, Multicentre Exploratory Study of Non-invasive Quantitative Assessment of Renal Graft Function With Non-contrast Functional Magnetic Resonance Imaging
Lead Sponsor:
Tongji Hospital
Collaborating Sponsors:
National Natural Science Foundation of China
Conditions:
Kidney Transplant
Renal Allograft Recipients
Eligibility:
All Genders
18+ years
Brief Summary
This clinical study aims to investigate a new, non-invasive method for monitoring kidney function after transplantation. Currently, assessing the health of a transplanted kidney often relies on blood ...
Detailed Description
This is a prospective, multicenter, hybrid cohort study designed to validate a non-contrast functional MRI protocol for the non-invasive, quantitative assessment of graft function in kidney transplant...
Eligibility Criteria
Inclusion Criteria:
Adult participants (age ≥ 18 years).
For the Paired Donor-Recipient Cohort:
Donor: Scheduled for living kidney donation, OR is a deceased organ donor who can undergo a pre-transplant MRI.
Recipient: Recipient of a kidney transplant or simultaneous pancreas-kidney transplant from the paired donor.
For the Independent Recipient Cohort:
Recipient: Recipient of a kidney transplant from a deceased donor for whom donor baseline data is unavailable.
Able to provide informed consent.
Exclusion Criteria:
Any contraindication to MRI (e.g., cardiac pacemaker, non-MRI compatible metallic implants, neurostimulators, severe claustrophobia).
Inability to tolerate the breath-holding required for MRI acquisition.
Pregnancy.
Any clinical condition that, in the investigator's judgment, would severely compromise study participation or data integrity (e.g., uncontrolled severe infection, active major psychiatric illness).
Key Trial Info
Start Date :
December 4 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2033
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT07333495
Start Date
December 4 2025
End Date
December 31 2033
Last Update
January 12 2026
Active Locations (3)
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1
Sinopharm Dongfeng General Hospital, Dongfeng Motor Corporation and Hubei University of Medicine.
Shiyan, Hubei, China
2
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
3
Shanxi Bethune Hospital, Shanxi Academy of Medical Sciences, Shanxi Medical University
Taiyuan, Shanxi, China