ARCF: Kidney Fibrosis and MRI

Sponsor
Children's Hospital Medical Center, Cincinnati (Other)
Overall Status
Completed
CT.gov ID
NCT03964948
Collaborator
(none)
37
1
4
34.4
1.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Kidney MRI
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
37 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Development of Novel MRI Methods for Detecting and Measuring Renal Injury/Fibrosis
Actual Study Start Date :
Aug 6, 2018
Actual Primary Completion Date :
Jun 18, 2021
Actual Study Completion Date :
Jun 18, 2021

Arms and Interventions

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.

Diagnostic Test: Kidney MRI
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.

Diagnostic Test: Kidney MRI
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.

Diagnostic Test: Kidney MRI
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.

Diagnostic Test: Kidney MRI
An MRI examination will be completed per research MRI protocol.

Outcome Measures

Primary Outcome Measures

  1. Development of noninvasive MRI methods to measure kidney disease using MR elastography. [3 years]

  2. Development of noninvasive MRI methods to measure kidney disease using quantitative T1 mapping. [3 years]

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

  4. Development of noninvasive MRI methods to measure kidney disease using T2 mapping. [3 years]

  5. Development of noninvasive MRI methods to measure kidney disease using magnetization transfer imaging. [3 years]

  6. Development of noninvasive MRI methods to measure kidney disease using diffusion-weighted imaging. [3 years]

    Intra-voxel incoherent motion and diffusion tensor imagining will be measured.

Eligibility Criteria

Criteria

Ages Eligible for Study:
10 Years to 25 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cincinnati Children's Hospital Medical Center Cincinnati Ohio United States 45229

Sponsors and Collaborators

  • Children's Hospital Medical Center, Cincinnati

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT03964948
Other Study ID Numbers:
  • 2018-4428
First Posted:
May 28, 2019
Last Update Posted:
Sep 9, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 9, 2021