Noninvasive Evaluation of Renal Allograft Fibrosis by MRI

Mayo Clinic

Status: Completed

Conditions: Kidney Transplantation

Treatments: Other: MRI 1.5T and 3.0T

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04899167

19-008333

R21AG062104 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The purpose of this study is to validate an MRI method to detect renal fibrosis in patients after kidney transplantation (KT).

Full description

The hypothesis underlying this proposal is that qMT reliably detects development of allograft fibrosis in human subjects after KT. To test this hypothesis, the qMT-derived bound pool fraction will be correlated with renal fibrosis as per biopsy in 20 patients 4 or 7 years after living donor KT. The bound pool fraction will also be compared to renal blood flow, oxygenation, and function, and the ability of qMT to provide consistent assessments of fibrosis tested at different magnetic field strengths. Two specific aims will test the hypotheses that: Specific Aim 1: qMT provides reliable and consequential assessment of fibrosis in human kidney allografts. Specific Aim 2: Renal fibrosis assessed by qMT in human kidney allografts is reproducible at 1.5 T and 3.0 T.

Enrollment: 22 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18-80 years
• Recipient of living donor kidney transplantation 4 or 7 years earlier
• Competent and able to provide written informed consent; Ability to comply with protocol

Exclusion criteria

• Patients have clinically significant medical conditions within the prior 6 months before: e.g. myocardial infarction, congestive heart failure, stroke, that would, in the opinion of the investigators, compromise the safety of the patient.
• Severe chronic liver, heart or lung disease
• Undergoing acute rejection
• Contra-indication to biopsy; bleeding disorders
• Chronic infection
• Any active malignancy and undergoing therapy
• Kidney or ureteric stone
• Unable to give valid informed consent
• Known pregnancy or intent to conceive during the study period
• Pacemaker, implantable defibrillator, magnetically active metal fragments, claustrophobia or other contraindication to MRI
• Federal medical center inmates.
• Latex allergy

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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22 participants in 2 patient groups

4 years after kidney transplantation

Experimental group

Description:

Patients 4 years after KT (N=10); 5 with estimated (e) glomerular filtration rate (GFR) ≤35 mL/min/1.73m2, and 5 with estimated (e) glomerular filtration rate (GFR)\>35 mL/min/1.73m2.

Treatment:

Other: MRI 1.5T and 3.0T

7 years after kidney transplantation

Experimental group

Description:

Patients 7 years after KT (N=10); 5 patients with eGFR ≤35 mL/min/1.73m2, and 5 with eGFR\>35 mL/min/1.73m2.

Treatment:

Other: MRI 1.5T and 3.0T