Non-contrast MRI tracking of kidney transplant function using donor baselines

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

This study will test whether non-contrast MRI scans can track kidney transplant health over time by using donor scans as personalized baselines and by applying the technique to recipients without donor data, for adults who have had or will receive a kidney transplant.

Quick facts

• Study type: Observational
• Enrollment: 1000 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Tongji Hospital (other)
• Locations: 3 sites (Shiyan, Hubei and 2 other locations)
• Trial ID: NCT07333495 on ClinicalTrials.gov

What this trial studies

This prospective, multicenter hybrid cohort study uses a standardized non-contrast functional MRI protocol (including DWI, ASL, BOLD, and MT sequences) to quantify renal perfusion, oxygenation, diffusion, and microstructure. The study enrolls paired donor-recipient sets where donors undergo pre-transplant MRI to create individualized baselines, plus an independent recipient cohort (primarily deceased-donor transplants) to validate MRI metrics without donor baselines. MRI measures will be integrated with body composition, metabolic profiles, and routine clinical and laboratory data to build models for early detection, treatment monitoring, and prognosis of graft function. Imaging and clinical data will be collected across multiple centers in China and analyzed for reproducibility and diagnostic performance.

Who should consider this trial

Good fit: Adults (≥18) who are living kidney donors and their matched recipients, or transplant recipients (especially from deceased donors) able to undergo MRI and provide informed consent are ideal candidates.

Not a fit: Patients with MRI contraindications (e.g., incompatible implants, severe claustrophobia), those unable to perform required breath-holds, pregnant people, or those with clinical conditions that preclude reliable participation are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this approach could enable earlier, non-invasive detection of graft dysfunction and reduce reliance on invasive biopsies.

How similar studies have performed: Pilot and single-center studies using ASL, BOLD, and DWI for renal grafts have shown promising signals, but large multicenter validation of a combined non-contrast protocol remains limited.

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).

Where this trial is running

Shiyan, Hubei and 2 other locations

• Sinopharm Dongfeng General Hospital, Dongfeng Motor Corporation and Hubei University of Medicine. — Shiyan, Hubei, China (NOT_YET_RECRUITING)
• Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (RECRUITING)
• Shanxi Bethune Hospital, Shanxi Academy of Medical Sciences, Shanxi Medical University — Taiyuan, Shanxi, China (NOT_YET_RECRUITING)

Study contacts

• Study coordinator: Zhen Professor Li, PHD,MD

Conditions: Kidney Transplant, Renal Allograft Recipients, Renal Allograft, renal allograft, MRI