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Kidney Fibrosis and MRI (ARCF)

Primary Purpose

Kidney Diseases

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Kidney MRI
Sponsored by
Children's Hospital Medical Center, Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Kidney Diseases

Eligibility Criteria

10 Years - 25 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Cincinnati Children's Hospital Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

Healthy Volunteers

Kidney Transplant

Stage 2-5 CKD

Lupus nephritis

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 20, 2019
Last Updated
September 8, 2021
Sponsor
Children's Hospital Medical Center, Cincinnati
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1. Study Identification

Unique Protocol Identification Number
NCT03964948
Brief Title
Kidney Fibrosis and MRI
Acronym
ARCF
Official Title
Development of Novel MRI Methods for Detecting and Measuring Renal Injury/Fibrosis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
August 6, 2018 (Actual)
Primary Completion Date
June 18, 2021 (Actual)
Study Completion Date
June 18, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Diseases

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy Volunteers
Arm Type
Other
Arm Description
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.
Arm Title
Kidney Transplant
Arm Type
Other
Arm Description
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.
Arm Title
Stage 2-5 CKD
Arm Type
Other
Arm Description
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.
Arm Title
Lupus nephritis
Arm Type
Other
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Kidney MRI
Intervention Description
An MRI examination will be completed per research MRI protocol.
Primary Outcome Measure Information:
Title
Development of noninvasive MRI methods to measure kidney disease using MR elastography.
Time Frame
3 years
Title
Development of noninvasive MRI methods to measure kidney disease using quantitative T1 mapping.
Time Frame
3 years
Title
Development of noninvasive MRI methods to measure kidney disease using T1rho mapping.
Time Frame
3 years
Title
Development of noninvasive MRI methods to measure kidney disease using T2 mapping.
Time Frame
3 years
Title
Development of noninvasive MRI methods to measure kidney disease using magnetization transfer imaging.
Time Frame
3 years
Title
Development of noninvasive MRI methods to measure kidney disease using diffusion-weighted imaging.
Description
Intra-voxel incoherent motion and diffusion tensor imagining will be measured.
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Kidney Fibrosis and MRI

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