Kidney Fibrosis and MRI (ARCF)

Development of Novel MRI Methods for Detecting and Measuring Renal Injury/Fibrosis

The investigators plan a prospective cross-sectional study of pediatric and adult healthy volunteers and patients with chronic kidney disease that will correlate a variety of quantitative MRI biomarkers with severity of renal insufficiency and available histopathology. Over 3 years, the investigators will recruit approximately 20 healthy volunteers, 20 patients with chronic kidney disease (CKD) Stage 2-5, and 20 patients with renal transplant kidneys. The investigators also plan to assess the effect of inflammation on the quantitative MRI biomarkers by recruiting approximately 20 additional patients with active lupus nephritis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Cincinnati Children's Hospital Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 25 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Subjects who meet all of the following criteria will be eligible for the study:

  1. ≥ 10 and ≤ 25 years of age and;
  2. Kidney transplant patients, who have had a recent kidney biopsy (within 1 year) that shows interstitial fibrosis OR
  3. Patients with CKD Stage 2-5 who have previously had a biopsy (within 1 year) OR
  4. Lupus patients with active nephritis who will undergo biopsy evaluation before and after induction therapy OR
  5. Healthy Controls

Exclusion Criteria:

Subjects who meet any of the following criteria will be excluded from the study:

  1. Known contraindication to MR imaging (e.g., implanted non-MRI compatible device)
  2. Known or suspected pregnancy. Female subjects of child bearing potential will undergo a urine pregnancy test prior to imaging.
  3. Inability to undergo MRI without sedation/anesthesia.
  4. Non-English Speaking

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Healthy Volunteers
20 healthy volunteers will be recruited and will receive a kidney MRI and the same blood and urine labs that are collected for the other arms. Results will be compared to the disease groups.
An MRI examination will be completed per research MRI protocol.
Other: Kidney Transplant
20 subjects that have received a kidney transplant that have had a biopsy performed within the past 12 months will be enrolled. They will receive a kidney MRI and will have blood and urine collected.
An MRI examination will be completed per research MRI protocol.
Other: Stage 2-5 CKD
20 subjects that have been diagnosed with stage 2-5 CKD and have had a biopsy performed within the past 12 months will be enrolled. They will receive a kidney MRI and will have blood and urine collected.
An MRI examination will be completed per research MRI protocol.
Other: Lupus nephritis

20 subjects that have that have active lupus nephritis and have had a biopsy performed within the past 12 months will be enrolled. They will receive a kidney MRI and will have blood and urine collected.

Subjects that are post-lupus treatment will receive an additional MRI at the time of the next biopsy.

An MRI examination will be completed per research MRI protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Development of noninvasive MRI methods to measure kidney disease using MR elastography.
Time Frame: 3 years
3 years
Development of noninvasive MRI methods to measure kidney disease using quantitative T1 mapping.
Time Frame: 3 years
3 years
Development of noninvasive MRI methods to measure kidney disease using T1rho mapping.
Time Frame: 3 years
3 years
Development of noninvasive MRI methods to measure kidney disease using T2 mapping.
Time Frame: 3 years
3 years
Development of noninvasive MRI methods to measure kidney disease using magnetization transfer imaging.
Time Frame: 3 years
3 years
Development of noninvasive MRI methods to measure kidney disease using diffusion-weighted imaging.
Time Frame: 3 years
Intra-voxel incoherent motion and diffusion tensor imagining will be measured.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 6, 2018

Primary Completion (Actual)

June 18, 2021

Study Completion (Actual)

June 18, 2021

Study Registration Dates

First Submitted

May 20, 2019

First Submitted That Met QC Criteria

May 24, 2019

First Posted (Actual)

May 28, 2019

Study Record Updates

Last Update Posted (Actual)

September 9, 2021

Last Update Submitted That Met QC Criteria

September 8, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-4428

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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