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Completed

NCT Number: NCT03964948

Kidney Fibrosis and MRI

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.

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Key information

Conditions

Kidney Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

10 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

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

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

Exclusion criteria

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

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

Treatment and study plan

Kidney MRI

Diagnostic Test

An MRI examination will be completed per research MRI protocol.

Primary outcomes

  1. Development of noninvasive MRI methods to measure kidney disease using MR elastography.

    Time frame: 3 years

  2. Development of noninvasive MRI methods to measure kidney disease using quantitative T1 mapping.

    Time frame: 3 years

  3. Development of noninvasive MRI methods to measure kidney disease using T1rho mapping.

    Time frame: 3 years

  4. Development of noninvasive MRI methods to measure kidney disease using T2 mapping.

    Time frame: 3 years

  5. Development of noninvasive MRI methods to measure kidney disease using magnetization transfer imaging.

    Time frame: 3 years

  6. 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.

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Registry information

Official study title

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

Acronym: ARCF

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
May 28, 2019
Registry last updated
Sep 9, 2021

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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