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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06445127
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Johns Hopkins University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Rebecca Krimins, DVM, MSHoma Timlin, MD, MSc, MRCP, CCST
Principal Investigator Affiliation Johns Hopkins School of MedicineJohns Hopkins School of Medicine
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Lupus Nephritis, Lupus Erythematosus, Systemic, Lupus, SLE, SLE Nephritis, SLE; Glomerulonephritis (Etiology), SLE (Systemic Lupus)
Additional Details

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.

Arms & Interventions

Arms

Experimental: MRI

A participant will undergo a MRI (1-4).

Interventions

Device: - MRI

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Baltimore, Maryland

Status

Recruiting

Address

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21287

Site Contact

Rebecca Krimins, DVM, MS

[email protected]

410-955-9617