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

NCT06445127 | Terminated

• 1 other identifier: IRB00354110
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

SLE (Systemic Lupus)

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Specialty clinic

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Johns Hopkins University: lead
• Janssen Scientific Affairs, LLC: collaborator

Study Sites (1)

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Homa Timlin, MD, MSc, MRCP, CCST

  Johns Hopkins School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2024
• First Posted: June 6, 2024
• Study Start: May 7, 2024
• Primary Completion: January 1, 2025
• Study Completion: April 8, 2025
• Last Updated: May 7, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)