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
• 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
• 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

Related Conditions & MeSH terms

• Fibrosis
• Kidney Transplantation

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

External Links

•   Mayo Clinic Clinical Trials