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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06445127
Other study ID # IRB00354110
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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