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OpenTrials
Completed

NCT Number: NCT04899167

Noninvasive Evaluation of Renal Allograft Fibrosis by MRI

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

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MRI 1.5T and 3.0T

Other

Magnetic Resonance Imaging for Renal Fibrosis

Primary outcomes

  1. The values and correlation of f with IF

    Time frame: 2 years

    Correlation of qMT with tissue fibrosis (trichrome)

Secondary outcomes

  1. The correlation of f with renal function attributes and pro-fibrogenic activity

    Time frame: 2 years

    Correlation of qMT with renal oxygenation, GFR, levels of fibrogenic factors.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
May 24, 2021
Registry last updated
Oct 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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