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

NCT07333495 | Recruiting DMC

• 1 other identifier: TJ-IRB202512022
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 3

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 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.

Conditions

Kidney Transplant; Renal Allograft Recipients; Renal Allograft

Keywords

renal allograft; MRI

Outcome Measures

Primary Outcomes (1)

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

  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.

  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

Secondary Outcomes (1)

• Correlation between Baseline Functional MRI Parameters and Long-Term Decline in Renal Allograft Function

  From the first functional MRI assessment post-transplant, with subsequent assessments of renal function at Years 1, 2, 3, 4, and 5.

Study Arms (2)

Paired Donor-Recipient Cohort

Kidney transplant recipients enrolled along with their corresponding donor (living or deceased). The donor undergoes a pre-transplant MRI to establish an individualized functional baseline for the graft. This cohort aims to achieve ultra-sensitive detection of post-transplant functional changes by comparing against the kidney's own baseline.

Independent Recipient Cohort

Kidney transplant recipients for whom donor baseline data is unavailable (primarily recipients of deceased donor kidneys). This cohort is used to validate the standalone capability of the non-contrast MRI protocol for monitoring graft function dynamics over time, addressing the common clinical scenario where donor information is absent.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will enroll adult (age ≥18 years) kidney transplant recipients and their corresponding donors from multiple participating transplant centers. This hybrid cohort comprises two distinct sub-populations: Paired Donor-Recipient Cohort: Includes both the transplant recipient and the living or deceased donor from whom the kidney originated. Independent Recipient Cohort: Includes transplant recipients (primarily from deceased donors) for whom paired donor baseline data is not available. All enrolled participants will undergo a standardized, non-contrast functional MRI assessment.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Tongji Hospital: lead
• National Natural Science Foundation of China: collaborator

Study Sites (3)

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

Central Study Contacts

Zhen Professor Li, PHD,MD

CONTACT

02783663543; zhenli@hust.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 12, 2025
• First Posted: January 12, 2026
• Study Start: December 4, 2025
• Primary Completion (Estimated): December 31, 2032
• Study Completion (Estimated): December 31, 2033
• Last Updated: January 12, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)