Systemic Lupus ErthematosusNCT06757725
Renal Resistive Index as an Indicator of Lupus Nephritis Severity and Systemic Lupus Activity
A study testing colour doppler of the renal artery and measurement of resistive index in people with Systemic Lupus Erthematosus and Lupus Glomerulonephritis, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
The study explores the role of the colour Doppler scanning of the renal arteries and its relation to the degree of disease affection in lupus nephritis Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Systemic Lupus Erthematosus, Lupus Glomerulonephritis, Lupus Flare
- What is being tested?
- colour doppler of the renal artery and measurement of resistive index
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Sep 2022to 15 Oct 2023
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. Systemic lupus erythematosus. 2. Lupus nephritis. 3. Adults >18 years old.
Who cannot join
- 1. End Stage Renal Disease. 2. Diabetes Mellitus. 3. Heart failure. 4. Hepatic diseases. 5. Obstructive nephropathy. 6. Renal artery stenosis or occlusion.
Trial locations and contacts
1 site in 1 country.
About this study
The study explores the role of the colour Doppler scanning of the renal arteries and its relation to the degree of disease affection in lupus nephritis
Read the detailed description
we have recruited patients into 3 groups The first group is patients with lupus nephritis The second groups is patients with systemic lupus erythromatosus without nephritis The third groups is normal healthy controls we explored the association of colour Doppler and the renal resistive index with the degree of the renal affection in lupus nephritis
- Being tested
- colour doppler of the renal artery and measurement of resistive index
- Keywords
- systimc lupus erythromatosus, lupus glomerulonephritis
- Medical subject headings
- Lupus Nephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
colour doppler of the renal artery and measurement of resistive indexDiagnostic test
using colour doppler to asses vascular resistance and resistive index
| Study group | Role | What they receive |
|---|---|---|
| Patients with lupus nephritis | Active comparator | Theses are 25 patients diagnosed with lupus nephritis Receives: Diagnostic Test: colour doppler of the renal artery and measurement of resistive index |
| Lupus without nephritis | Active comparator | Theses are 25 patients diagnosed with lupus without evidence of nephritis Receives: Diagnostic Test: colour doppler of the renal artery and measurement of resistive index |
| Healthy control | No intervention | Patients who are healthy volunteers with no evidence of nephritis or systemic lupus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resistive index
The resistive index of the renal arteries as measured by the colour Doppler
Measured: At the time of recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2025
- Study start3 Sep 2022
- Primary completion13 Oct 2023
- Study completion15 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErthematosusStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tarek Samy Abdelaziz, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06757725
- Sponsor's protocol ID
- MS-632-2022
- Other IDs
- MS-632-2022
- Status last verified
- Dec 2024
- First submitted
- 27 Dec 2024
- Last updated
- 3 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Can be shared upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renal Resistive Index as an Indicator of Lupus Nephritis Severity and Systemic Lupus Activity
- ClinicalTrials.gov ID
- NCT06757725
- Acronym / sponsor ID
- MS-632-2022
- Keywords
- systimc lupus erythromatosus, lupus glomerulonephritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 3 Sep 2022 (actual)
- Primary completion
- 13 Oct 2023 (actual)
- Study completion
- 15 Oct 2023 (actual)
- First posted
- 3 Jan 2025 (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.
The study explores the role of the colour Doppler scanning of the renal arteries and its relation to the degree of disease affection in lupus nephritis
Detailed description
we have recruited patients into 3 groups The first group is patients with lupus nephritis The second groups is patients with systemic lupus erythromatosus without nephritis The third groups is normal healthy controls we explored the association of colour Doppler and the renal resistive index with the degree of the renal affection in lupus nephritis
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with lupus nephritis | Active comparator | Diagnostic Test: colour doppler of the renal artery and measurement of resistive indexTheses are 25 patients diagnosed with lupus nephritis |
| Lupus without nephritis | Active comparator | Diagnostic Test: colour doppler of the renal artery and measurement of resistive indexTheses are 25 patients diagnosed with lupus without evidence of nephritis |
| Healthy control | No intervention | –Patients who are healthy volunteers with no evidence of nephritis or systemic lupus |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Systemic lupus erythematosus. 2. Lupus nephritis. 3. Adults >18 years old.
Key exclusion criteria (1 listed)
- 1. End Stage Renal Disease. 2. Diabetes Mellitus. 3. Heart failure. 4. Hepatic diseases. 5. Obstructive nephropathy. 6. Renal artery stenosis or occlusion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| colour doppler of the renal artery and measurement of resistive indexusing colour doppler to asses vascular resistance and resistive index | Diagnostic test | Lupus without nephritis, Patients with lupus nephritis |
Primary outcome
Resistive index
Time frame: At the time of recruitment
The resistive index of the renal arteries as measured by the colour Doppler
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2025.
- Individual participant dataSharing planned: Undecided. Can be shared upon reasonable request
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing colour doppler of the renal artery and measurement of resistive index in people with Systemic Lupus Erthematosus and Lupus Glomerulonephritis, run by Kasr El Aini Hospital at 1 site in Egypt.
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 1 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: finished, as of the sponsor's last update on 3 Jan 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 Egypt. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Resistive index (time frame: At the time of recruitment). 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 3 Jan 2025.