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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Page 1 of 1 (3 locations)

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