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

May 2, 2025 updated by: Johns Hopkins University
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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Homa Timlin, MD, MSc, MRCP, CCST
  • Phone Number: 410-550-4579
  • Email: htimlin1@jhmi.edu

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Presence of inflammation
Time Frame: Six months
The presence of inflammation within both kidneys will be measured using MRI.
Six months
Presence of fibrosis
Time Frame: Six months
The presence of fibrosis within both kidneys will be measured using MRI.
Six months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Inflammation in the kidneys will be correlated to Urine Protein Creatinine Ratio (UPCR)
Time Frame: Six months
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)
Time Frame: Six months
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)
Time Frame: Six months
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
Time Frame: Six months

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
Time Frame: Six months

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
Time Frame: Six months

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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Johns Hopkins University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Janssen Scientific Affairs, LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Homa Timlin, MD, MSc, MRCP, CCST, Johns Hopkins School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 7, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 8, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 13, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 31, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 6, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 7, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 2, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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