SLE (Systemic Lupus)NCT06445127
Evaluation of Patients With Lupus Nephritis Using Kidney MRI (Magnetic Resonance Imaging)
An observational study of SLE (Systemic Lupus), run by Johns Hopkins University at 1 site in United States.
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 in patients with systemic lupus erythematosus (SLE). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SLE (Systemic Lupus)
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 7 May 2024to 8 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Specialty clinic
Who may be able to join
- Male and female adults over the age of 18 who have been diagnosed with SLE and are able to undergo a kidney MRI.
Who cannot join
- Any patient that has undergone a renal transplant.
- Any patient that is receiving renal dialysis
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21287
About this study
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)
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Presence of inflammation
The presence of inflammation within both kidneys will be measured using MRI.
Measured: Six months
Presence of fibrosis
The presence of fibrosis within both kidneys will be measured using MRI.
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2024
- Study start7 May 2024
- Primary completion1 Jan 2025
- Study completion8 Apr 2025
Why it stopped: Occurrence of unforeseen study issues and a presence of unanticipated risks that cannot be adequately quantified.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SLE (Systemic Lupus)Studies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen Scientific Affairs, LLC
- Responsible party
- Sponsor
- Investigators
- Homa Timlin, MD, MSc, MRCP, CCST, Principal investigator, Johns Hopkins School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06445127
- Sponsor's protocol ID
- IRB00354110
- Status last verified
- May 2025
- First submitted
- 13 May 2024
- Last updated
- 7 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Patients With Lupus Nephritis Using Kidney MRI (Magnetic Resonance Imaging)
- ClinicalTrials.gov ID
- NCT06445127
- Acronym / sponsor ID
- IRB00354110
- Conditions
- SLE (Systemic Lupus)
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Occurrence of unforeseen study issues and a presence of unanticipated risks that cannot be adequately quantified.
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Janssen Scientific Affairs, LLC
- Study start
- 7 May 2024 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 8 Apr 2025 (actual)
- First posted
- 6 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Specialty clinic
Key inclusion criteria (1 listed)
- Male and female adults over the age of 18 who have been diagnosed with SLE and are able to undergo a kidney MRI.
Key exclusion criteria (2 listed)
- Any patient that has undergone a renal transplant.
- Any patient that is receiving renal dialysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Presence of inflammation
Time frame: Six months
The presence of inflammation within both kidneys will be measured using MRI.
Presence of fibrosis
Time frame: Six months
The presence of fibrosis within both kidneys will be measured using MRI.
Results and safety
The study was stopped early (reason given: Occurrence of unforeseen study issues and a presence of unanticipated risks that cannot be adequately quantified.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2025.
- Individual participant dataSharing planned: No
Related trials for SLE (Systemic Lupus)
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Recruiting
Effect of Anti-inflammatory Diet in Systemic Lupus Erythematous
Systemic Lupus Erthematosus (SLE)
RecruitingObservational study
Electroencephalogram Recording in Patients With Systemic Lupus Erythematosus
Systemic Lupus Erythematosus
RecruitingObservational study
Deciphering the Genetic Architecture of Autoimmune Diseases
Autoimmune Diseases
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Homa Timlin, MD, MSc, MRCP, CCST principal investigator
Johns Hopkins School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SLE (Systemic Lupus), run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Occurrence of unforeseen study issues and a presence of unanticipated risks that cannot be adequately quantified.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of inflammation (time frame: Six months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2025.