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Noninvasive Evaluation of Renal Allograft Fibrosis by MRI

Primary Purpose

Kidney Transplantation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MRI 1.5T and 3.0T
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Kidney Transplantation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

4 years after kidney transplantation

7 years after kidney transplantation

Arm 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.

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.

Outcomes

Primary Outcome Measures

The values and correlation of f with IF
Correlation of qMT with tissue fibrosis (trichrome)

Secondary Outcome Measures

The correlation of f with renal function attributes and pro-fibrogenic activity
Correlation of qMT with renal oxygenation, GFR, levels of fibrogenic factors.

Full Information

First Posted
May 19, 2021
Last Updated
October 3, 2023
Sponsor
Mayo Clinic
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT04899167
Brief Title
Noninvasive Evaluation of Renal Allograft Fibrosis by MRI
Official Title
Noninvasive Evaluation of Renal Allograft Fibrosis by MRI
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
August 30, 2023 (Actual)
Study Completion Date
August 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Transplantation

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, unblinded, Parallel, imaging study
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
4 years after kidney transplantation
Arm Type
Experimental
Arm 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.
Arm Title
7 years after kidney transplantation
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
MRI 1.5T and 3.0T
Intervention Description
Magnetic Resonance Imaging for Renal Fibrosis
Primary Outcome Measure Information:
Title
The values and correlation of f with IF
Description
Correlation of qMT with tissue fibrosis (trichrome)
Time Frame
2 years
Secondary Outcome Measure Information:
Title
The correlation of f with renal function attributes and pro-fibrogenic activity
Description
Correlation of qMT with renal oxygenation, GFR, levels of fibrogenic factors.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lilach Lerman, MD, PhD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

Noninvasive Evaluation of Renal Allograft Fibrosis by MRI

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