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

Condition(s) studied

Study 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.

Eligibility

Primary outcome measure(s)

• Diagnostic Accuracy of Functional MRI for pathology in Kidney Transplant Recipients (Including T-Cell Mediated and Antibody-Mediated Rejection) — 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
  At the time of each clinically indicated biopsy, the required data (e.g., for functional MRI) will be collected. The results will be compared against the reference standard of histopathological diagnosis from the concurrent transplant kidney biopsy, graded according to the updated Banff classification criteria. The primary analysis will be the diagnostic sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV), each presented with a 95% confidence interval. Secondary analysis will include the correlation between the functional MRI findings and the severity grade of Banff lesions.

Trial sites (3)

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