Kidney Fibrosis and MRI

Kidney Diseases Clinical Trial

— ARCF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03964948
• Other study ID #: 2018-4428
• Status: Completed
• Phase: N/A
• Start date: August 6, 2018
• Est. completion date: June 18, 2021

Study information

• Verified date: September 2021
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: June 18, 2021
• Est. primary completion date: June 18, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Kidney Diseases

Intervention

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

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Development of noninvasive MRI methods to measure kidney disease using MR elastography.		3 years
Primary	Development of noninvasive MRI methods to measure kidney disease using quantitative T1 mapping.		3 years
Primary	Development of noninvasive MRI methods to measure kidney disease using T1rho mapping.		3 years
Primary	Development of noninvasive MRI methods to measure kidney disease using T2 mapping.		3 years
Primary	Development of noninvasive MRI methods to measure kidney disease using magnetization transfer imaging.		3 years
Primary	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