Noninvasive Evaluation of Renal Allograft Fibrosis by MRI | NCT04899167

Studies
Noninvasive Evaluation of Renal Allograft Fibrosis by MRI

NCT04899167

Sponsor

Mayo Clinic

Status

Completed

Last Update Posted

Oct 5, 2023Actual

Enrollment

22Actual

Phase

Not Applicable

Conditions

Kidney Transplantation

Interventions

MRI 1.5T and 3.0T

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R21AG062104	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Oct 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2021Actual

Primary Completion Date

Aug 30, 2023Actual

Completion Date

Aug 30, 2023Actual

First Submitted Date

May 19, 2021

First Submission Date that Met QC Criteria

May 19, 2021

First Posted Date

May 24, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 3, 2023

Last Update Posted Date

Oct 5, 2023Actual

Name	Class
National Institute on Aging (NIA)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

22Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
4 years after kidney transplantation	Experimental	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.	Other: MRI 1.5T and 3.0T
7 years after kidney transplantation	Experimental	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.	Other: MRI 1.5T and 3.0T

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MRI 1.5T and 3.0T	Other	Magnetic Resonance Imaging for Renal Fibrosis	4 years after kidney transplantation 7 years after kidney transplantation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The values and correlation of f with IF	Correlation of qMT with tissue fibrosis (trichrome)	2 years

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lilach Lerman, MD, PhD	Mayo Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic in Rochester		Rochester	Minnesota	55905	United States