Evaluation of Patients With Lupus Nephritis Using Kidney MRI (Magnetic Resonance Imaging)

This study is being done to find out if a non-invasive Magnetic Resonance Imaging (MRI) examination of the kidneys may be helpful in patients with systemic lupus erythematosus (SLE).

Study Overview

• Status: Terminated
• Conditions: SLE (Systemic Lupus)
• Intervention / Treatment: Device: MRI

Detailed Description

The primary objective of this research is to evaluate the best techniques for magnetic resonance imaging (MRI) of the kidneys in patients with lupus nephritis. This research is being done to evaluate a minimally-invasive method for assessing kidney inflammation and kidney damage in patients with lupus nephritis. Both kidneys will be assessed.

• Study Type: Observational
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Specialty clinic

Description

Inclusion Criteria:

• Male and female adults over the age of 18 who have been diagnosed with SLE and are able to undergo a kidney MRI.

Exclusion Criteria:

• Any patient that has undergone a renal transplant.
• Any patient that is receiving renal dialysis

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Known Lupus Nephritis, with elevated UPCR result; Patients will have one scan at baseline, and one every 4 weeks thereafter for 3 visits. The final imaging session is after 6 months of routine therapy.
No known lupus nephritis; Patients will have one MRI
Known Lupus Nephritis, with normal Urine Protein Creatinine Ratio (UPCR) result; Patients will have one scan at baseline, and one every 4 weeks thereafter for 3 visits.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of inflammation	The presence of inflammation within both kidneys will be measured using MRI.	Six months
Presence of fibrosis	The presence of fibrosis within both kidneys will be measured using MRI.	Six months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inflammation in the kidneys will be correlated to Urine Protein Creatinine Ratio (UPCR)	MRI findings of inflammation will be correlated to UPCR above and below 0.5 grams.	Six months
Fibrosis in the kidneys will be correlated to UPCR (Urine Protein Creatinine Ratio)	MRI findings of fibrosis will be correlated to UPCR above and below 0.5 grams.	Six months
Atrophy in the kidneys will be correlated to UPCR (Urine Protein Creatinine Ratio)	MRI findings of atrophy will be correlated to UPCR above and below 0.5 grams.	Six months
Inflammation will be correlated with kidney biopsy classes	Detection of inflammation within both kidneys will be correlated to class I-VI lupus nephritis confirmed by the kidney biopsy. Class I: Minimal Mesangial Nephritis Class II: Mesangial Proliferative Nephritis Class III: Focal Nephritis Class IV: Diffuse Nephritis Class V: Membranous Nephritis Class VI: Advanced Sclerosing Nephritis	Six months
Atrophy will be correlated with kidney biopsy classes	Detection of atrophy within both kidneys will be correlated to class I-VI lupus nephritis confirmed by the kidney biopsy. Class I: Minimal Mesangial Nephritis Class II: Mesangial Proliferative Nephritis Class III: Focal Nephritis Class IV: Diffuse Nephritis Class V: Membranous Nephritis Class VI: Advanced Sclerosing Nephritis	Six months
Fibrosis will be correlated with kidney biopsy classes	Detection of fibrosis within both kidneys will be correlated to class I-VI lupus nephritis confirmed by the kidney biopsy. Class I: Minimal Mesangial Nephritis Class II: Mesangial Proliferative Nephritis Class III: Focal Nephritis Class IV: Diffuse Nephritis Class V: Membranous Nephritis Class VI: Advanced Sclerosing Nephritis	Six months

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: Janssen Scientific Affairs, LLC
• Investigators: Principal Investigator: Homa Timlin, MD, MSc, MRCP, CCST, Johns Hopkins School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2024
• Primary Completion (Actual): January 1, 2025
• Study Completion (Actual): April 8, 2025

Study Registration Dates

• First Submitted: May 13, 2024
• First Submitted That Met QC Criteria: May 31, 2024
• First Posted (Actual): June 6, 2024

Study Record Updates

• Last Update Posted (Actual): May 7, 2025
• Last Update Submitted That Met QC Criteria: May 2, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Lupus; Lupus nephritis; Lupus SLE; Kidney disease in lupus; Renal disease in lupus; Lupus and kidneys; Protein in urine; Inflammation in the kidney in patients with lupus; Lupus and kidney impairment
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Glomerulonephritis; Lupus Erythematosus, Systemic; Nephritis; Lupus Nephritis
• Other Study ID Numbers: IRB00354110

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No