Noninvasive Evaluation of Renal Allograft Fibrosis by MRI
2 other identifiers
interventional
22
1 country
1
Brief Summary
The purpose of this study is to validate an MRI method to detect renal fibrosis in patients after kidney transplantation (KT).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 19, 2021
CompletedFirst Posted
Study publicly available on registry
May 24, 2021
CompletedStudy Start
First participant enrolled
August 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2023
CompletedOctober 5, 2023
October 1, 2023
2.1 years
May 19, 2021
October 3, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
The values and correlation of f with IF
Correlation of qMT with tissue fibrosis (trichrome)
2 years
Secondary Outcomes (1)
The correlation of f with renal function attributes and pro-fibrogenic activity
2 years
Study Arms (2)
4 years after kidney transplantation
EXPERIMENTALPatients 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
EXPERIMENTALPatients 7 years after KT (N=10); 5 patients with eGFR ≤35 mL/min/1.73m2, and 5 with eGFR\>35 mL/min/1.73m2.
Interventions
Magnetic Resonance Imaging for Renal Fibrosis
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
- National Institute on Aging (NIA)collaborator
Study Sites (1)
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Related Links
Study Officials
- PRINCIPAL INVESTIGATOR
Lilach Lerman, MD, PhD
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 19, 2021
First Posted
May 24, 2021
Study Start
August 1, 2021
Primary Completion
August 30, 2023
Study Completion
August 30, 2023
Last Updated
October 5, 2023
Record last verified: 2023-10