Kidney Fibrosis and MRI

Study Overview
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Brief Summary
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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.

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

Conditions
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Kidney Diseases

Intervention / Treatment
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* Diagnostic Test: Kidney MRI


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Healthy Volunteers<br>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<br>* An MRI examination will be completed per research MRI protocol.<br>|
| Other: Kidney Transplant<br>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<br>* An MRI examination will be completed per research MRI protocol.<br>|
| Other: Stage 2-5 CKD<br>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<br>* An MRI examination will be completed per research MRI protocol.<br>|
| Other: Lupus nephritis<br>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<br>* An MRI examination will be completed per research MRI protocol.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Intra-voxel incoherent motion and diffusion tensor imagining will be measured. | 3 years |