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NCT04899167 Clinical Trial

Noninvasive Evaluation of Renal Allograft Fibrosis by MRI

Kidney Transplantation Clinical Trial

Official title:
Noninvasive Evaluation of Renal Allograft Fibrosis by MRI

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04899167
Other study ID # 19-008333
Secondary ID R21AG062104
Status Completed
Phase N/A
First received
Last updated
Start date August 1, 2021
Est. completion date August 30, 2023

Study information
Verified date October 2023
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 22
Est. completion date August 30, 2023
Est. primary completion date August 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• MRI 1.5T and 3.0T
Magnetic Resonance Imaging for Renal Fibrosis

Locations
Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (2)
Lead Sponsor Collaborator
Mayo Clinic National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary The values and correlation of f with IF Correlation of qMT with tissue fibrosis (trichrome) 2 years
Secondary 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
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