Kidney Fibrosis and MRI
- Conditions
- Kidney Diseases
- Interventions
- Diagnostic Test: Kidney MRI
- Registration Number
- NCT03964948
- Lead Sponsor
- Children's Hospital Medical Center, Cincinnati
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 37
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
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Stage 2-5 CKD Kidney MRI 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. Healthy Volunteers Kidney MRI 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. Kidney Transplant Kidney MRI 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. Lupus nephritis Kidney MRI 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.
- Primary Outcome Measures
Name Time Method 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 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 diffusion-weighted imaging. 3 years Intra-voxel incoherent motion and diffusion tensor imagining will be measured.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States