Noninvasive Evaluation of Renal Allograft Fibrosis by MRI

Not Applicable

Completed

• Conditions: Kidney Transplantation
• Interventions: Other: MRI 1.5T and 3.0T

• Registration Number: NCT04899167
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study First Submitted: 2021-05-19
• Study First Submitted QC: 2021-05-19
• Study First Posted: 2021-05-24
• Study Start: 2021-08-01
• Primary Completion: 2023-08-30
• Study Completion: 2023-08-30
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-03
• Last Update Posted: 2023-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
4 years after kidney transplantation	MRI 1.5T and 3.0T	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.
7 years after kidney transplantation	MRI 1.5T and 3.0T	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.

Primary Outcome Measures

Name	Time	Method
The values and correlation of f with IF	2 years	Correlation of qMT with tissue fibrosis (trichrome)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States