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Kidney Fibrosis and MRI

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03964948
Acronym
ARCF
Enrollment
37
Registered
2019-05-28
Start date
2018-08-06
Completion date
2021-06-18
Last updated
2021-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Diseases

Brief summary

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.

Interventions

DIAGNOSTIC_TESTKidney MRI

An MRI examination will be completed per research MRI protocol.

Sponsors

Children's Hospital Medical Center, Cincinnati
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
10 Years to 25 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Development of noninvasive MRI methods to measure kidney disease using MR elastography.3 years
Development of noninvasive MRI methods to measure kidney disease using quantitative T1 mapping.3 years
Development of noninvasive MRI methods to measure kidney disease using T1rho mapping.3 years
Development of noninvasive MRI methods to measure kidney disease using T2 mapping.3 years
Development of noninvasive MRI methods to measure kidney disease using magnetization transfer imaging.3 years
Development of noninvasive MRI methods to measure kidney disease using diffusion-weighted imaging.3 yearsIntra-voxel incoherent motion and diffusion tensor imagining will be measured.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026