Noninvasive Evaluation of Renal Allograft Fibrosis by MRI

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-01

Study Completion Date

2023-08-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Kidney Transplantation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Prospective, unblinded, Parallel, imaging study

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

MRI 1.5T and 3.0T

Intervention Type OTHER

Magnetic Resonance Imaging for Renal Fibrosis

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.

Group Type EXPERIMENTAL

MRI 1.5T and 3.0T

Intervention Type OTHER

Magnetic Resonance Imaging for Renal Fibrosis

Interventions

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MRI 1.5T and 3.0T

Magnetic Resonance Imaging for Renal Fibrosis

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No