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Noninvasive Evaluation of Renal Allograft Fibrosis by MRI

Noninvasive Evaluation of Renal Allograft Fibrosis by MRI

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04899167
Enrollment
22
Registered
2021-05-24
Start date
2021-08-01
Completion date
2023-08-30
Last updated
2023-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Transplantation

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.

Interventions

OTHERMRI 1.5T and 3.0T

Magnetic Resonance Imaging for Renal Fibrosis

Sponsors

National Institute on Aging (NIA)
CollaboratorNIH
Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Intervention model description

Prospective, unblinded, Parallel, imaging study

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The values and correlation of f with IF2 yearsCorrelation of qMT with tissue fibrosis (trichrome)

Secondary

MeasureTime frameDescription
The correlation of f with renal function attributes and pro-fibrogenic activity2 yearsCorrelation of qMT with renal oxygenation, GFR, levels of fibrogenic factors.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026