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

Lupus Nephritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06445127
• Other study ID #: IRB00354110
• Status: Recruiting
• Phase: N/A
• Start date: May 7, 2024
• Est. completion date: May 17, 2026

Study information

• Verified date: May 2024
• Source: Johns Hopkins University
• Contact: Rebecca Krimins, DVM, MS
• Phone: 410-955-9617
• Email: rkrimin1[@]jhmi.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is being done to find out if a non-invasive Magnetic Resonance Imaging (MRI) examination of the kidneys may be helpful for diagnosing lupus nephritis in patients with systemic lupus erythematosus (SLE). Participation involves having a kidney MRI that will take between 30 to 60 minutes. Participants may have 1-4 kidney MRIs over a 6-month time period.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: May 17, 2026
• Est. primary completion date: May 17, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

• The participant cannot take part in the study if they have any contraindications to MRI as specified by the current clinical MRI screening protocols including: metallic foreign objects within the body, programmable shunt/shunt, epidural or Swan Ganz catheter, ear or cochlear implant, eye implant, aneurysm clip, pacemaker/wires, internal defibrillator, tissue expander, recent stent placement, blood vessel coil, tracheostomy, stimulator/wires, infusion pump, penile prosthesis, intra-uterine device (IUD), surgical clips, bullets/pellets/bullet ball (BB), medication patch, tattoo, artificial limb, history of welding or metal fragments in eyes, pregnancy, claustrophobia, requirement of conscious sedation or anesthesia, colonoscopy procedure in the last 8 weeks.
• Any patient that is receiving renal dialysis.
• Any patient that has undergone a renal transplant.

Related Conditions & MeSH terms

• Glomerulonephritis
• Lupus
• Lupus Erythematosus, Systemic
• Lupus Nephritis
• Nephritis
• SLE
• SLE (Systemic Lupus)

Intervention

Device:
• MRI
A non-invasive, non-contrast, renal MRI will be performed.

Locations

Country	Name	City	State
United States	Johns Hopkins University School of Medicine	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	Janssen Scientific Affairs, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of inflammation	The presence of inflammation within both kidneys will be measured using MRI.	Six months
Primary	Presence of fibrosis	The presence of fibrosis within both kidneys will be measured using MRI.	Six months
Primary	Presence of atrophy	The presence of atrophy within both kidneys will be measured using MRI.	Six months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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