Noninvasive Evaluation of Renal Allograft Fibrosis by MRI

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

Study Overview

• Status: Completed
• Conditions: Kidney Transplantation
• Intervention / Treatment: Other: MRI 1.5T and 3.0T

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 4 years after kidney transplantation; 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.	Other: MRI 1.5T and 3.0T; Magnetic Resonance Imaging for Renal Fibrosis
Experimental: 7 years after kidney transplantation; 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.	Other: MRI 1.5T and 3.0T; Magnetic Resonance Imaging for Renal Fibrosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The values and correlation of f with IF	Correlation of qMT with tissue fibrosis (trichrome)	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The correlation of f with renal function attributes and pro-fibrogenic activity	Correlation of qMT with renal oxygenation, GFR, levels of fibrogenic factors.	2 years

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Lilach Lerman, MD, PhD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Actual): August 30, 2023
• Study Completion (Actual): August 30, 2023

Study Registration Dates

• First Submitted: May 19, 2021
• First Submitted That Met QC Criteria: May 19, 2021
• First Posted (Actual): May 24, 2021

Study Record Updates

• Last Update Posted (Actual): October 5, 2023
• Last Update Submitted That Met QC Criteria: October 3, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis
• Other Study ID Numbers: 19-008333; R21AG062104 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No