RecruitingNot Applicable

A Mixed Cohort, Multicentre Exploratory Study of Non-invasive Quantitative Assessment of Renal Graft Function With Non-contrast Functional Magnetic Resonance Imaging

China1,000 participantsStarted 2025-12-04

Plain-language 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 tests or invasive biopsies, which may not detect subtle early changes or account for each kidney's unique starting point. This research will use advanced, non-contrast Magnetic Resonance Imaging (MRI) scans to measure various aspects of kidney health, such as blood flow and oxygen levels. The study includes two main groups of participants: 1) kidney transplant donors and their matched recipients, and 2) transplant recipients whose donors are unavailable for study (e.g., deceased donors). For donor-recipient pairs, the goal is to create a personalized "baseline" for each transplanted kidney by scanning the donor before donation. This allows doctors to compare the kidney's function after transplant to its own unique starting point, potentially detecting problems much earlier. For recipients without donor data, the study will evaluate how well the MRI scans can track changes in kidney function over time on their own. Additionally, the study will analyze body composition (like fat and muscle distribution) and metabolic health to understand their relationship with transplant kidney function. We plan to enroll approximately 1000 participants across multiple hospitals. The ultimate goal is to develop a more accurate, individualized, and non-invasive tool for the early detection of transplant kidney problems, helping to improve long-term outcomes and quality of life for transplant patients.

Who can participate

Age range18 Years

SexALL

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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).

What they're measuring

Diagnostic Accuracy of Functional MRI for pathology in Kidney Transplant Recipients (Including T-Cell Mediated and Antibody-Mediated Rejection)

Timeframe: From the time of transplantation hospitalization until the end of the study follow-up period (up to 5 years). Assessments will be performed at each time point where a transplant kidney biopsy is deemed necessary by the clinician

Trial details

NCT IDNCT07333495

SponsorTongji Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2032-12-31

Contact for this trial

Zhen Professor Li, PHD,MD

02783663543 zhenli@hust.edu.cn

View on ClinicalTrials.gov More Kidney Transplant trials