Lupus NephritisNCT06631404
Renal Arterial Resistive Index as a Noninvasive Biomarker of Disease Activity in Lupus Nephritis Patients
An observational study of Lupus Nephritis, run by Sohag University at 1 site in Egypt.
Trial summary
Systemic Lupus Erthymatosous (SLE) is achronic inflammatory multi system auto immue disease characterized by pathogenic auto anti bodies production against nuclear structures (Bolouri et al.,2022), SLE affecting mainly woemn of childbearing age and is chracterized by unpredictable flares and remissions , disease… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Lupus Nephritis
- What is being tested?
- renal doppler
- How many people
- 55 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2024to 30 Oct 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 to 50 years
- All sexes
- Adult
Study population: Aged ≥18 years. * SLE patients fulfilling the SLE International Collaborating Clinics (SLICC) classification criteria and matched controls. * Patients cooperative and can answer questions. * Patients who are able and willing to give written informed consent.
Who may be able to join
- Aged ≥18 years.
- SLE patients fulfilling the SLE International Collaborating Clinics (SLICC) classification criteria and matched controls.
- Patients cooperative and can answer questions.
- Patients who are able and willing to give written informed consent.
Who cannot join
- • Individuals with other autoimmune diseases.
- Diabetes.
- Hypertension.
- Heart failure.
- Hepatic diseases.
- Chronic renal failure.
Show all 13Show fewer
- Renal artery stenosis.
- Renal vein thrombosis.
- Intrarenal arteriovenous fistula.
- Obstructive nephropathy.
- Urinary tract obstruction that could affect RI of intra renal arteries.
- Un cooperative patients.
- Patients not able and willing to give written informed consent.
Trial locations and contacts
1 site in 1 country.
Esam M Abualfadl, professor contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag university Hospital
Sohag, Sohag
Magdy M Amin, professor
About this study
Systemic Lupus Erthymatosous (SLE) is achronic inflammatory multi system auto immue disease characterized by pathogenic auto anti bodies production against nuclear structures (Bolouri et al.,2022), SLE affecting mainly woemn of childbearing age and is chracterized by unpredictable flares and remissions , disease variety varied from mild episode disorder to arpidly progressive life -threatening illness..
LN is diagnosed by either the presence of proteinuria >0.5g/day. active urinary sediment , or an unexplained rise in serum creatinine there fore , identifying new invasive biomarkers of LN severity and outcome is mandatory, Renal Arterial resistive index ( RRI) is anon invasive biomarker that has been studied as apotential indicator of disease activity in LN patients.
- Conditions
- Lupus Nephritis
- Being tested
- renal doppler
- Medical subject headings
- Lupus Nephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
renal dopplerDiagnostic test
doppler srudy on renal arteries bilaterally , and detection of RI of renal artery
| Study group | Role | What they receive |
|---|---|---|
| group SLE | Patients with SLE Receives: Diagnostic Test: renal doppler | |
| group control | matched healthy subjects Receives: Diagnostic Test: renal doppler |
What is being measured
The primary outcome is the main question the study is designed to answer.
doppler for renal artery
resistive index of renal artery
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start1 Oct 2024
- Primary completion30 Oct 2025 (estimated)
- Study completion30 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Lupus NephritisStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doaa Rabea Abdelkarim, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06631404
- Sponsor's protocol ID
- Soh-Med-24-09-07MS
- Status last verified
- Oct 2024
- First submitted
- 7 Oct 2024
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Alforaih N, Whittall-Garcia L, Touma Z. A Review of Lupus Nephritis. J Appl Lab Med. 2022 Oct 29;7(6):1450-1467. doi: 10.1093/jalm/jfac036.
PubMed 35932197Ameer MA, Chaudhry H, Mushtaq J, Khan OS, Babar M, Hashim T, Zeb S, Tariq MA, Patlolla SR, Ali J, Hashim SN, Hashim S. An Overview of Systemic Lupus Erythematosus (SLE) Pathogenesis, Classification, and Management. Cureus. 2022 Oct 15;14(10):e30330. doi: 10.7759/cureus.30330. eCollection 2022 Oct.
PubMed 36407159Anders HJ, Saxena R, Zhao MH, Parodis I, Salmon JE, Mohan C. Lupus nephritis. Nat Rev Dis Primers. 2020 Jan 23;6(1):7. doi: 10.1038/s41572-019-0141-9.
PubMed 31974366Anstee QM, Castera L, Loomba R. Impact of non-invasive biomarkers on hepatology practice: Past, present and future. J Hepatol. 2022 Jun;76(6):1362-1378. doi: 10.1016/j.jhep.2022.03.026.
PubMed 35589256
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renal Arterial Resistive Index as a Noninvasive Biomarker of Disease Activity in Lupus Nephritis Patients
- ClinicalTrials.gov ID
- NCT06631404
- Acronym / sponsor ID
- Soh-Med-24-09-07MS
- Conditions
- Lupus Nephritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 8 Oct 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.
Systemic Lupus Erthymatosous (SLE) is achronic inflammatory multi system auto immue disease characterized by pathogenic auto anti bodies production against nuclear structures (Bolouri et al.,2022), SLE affecting mainly woemn of childbearing age and is chracterized by unpredictable flares and remissions , disease variety varied from mild episode disorder to arpidly progressive life -threatening illness..
LN is diagnosed by either the presence of proteinuria >0.5g/day. active urinary sediment , or an unexplained rise in serum creatinine there fore , identifying new invasive biomarkers of LN severity and outcome is mandatory, Renal Arterial resistive index ( RRI) is anon invasive biomarker that has been studied as apotential indicator of disease activity in LN patients.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group SLE | – | Diagnostic Test: renal dopplerPatients with SLE |
| group control | – | Diagnostic Test: renal dopplermatched healthy subjects |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Age groups
- Adult
- Study population
- Aged ≥18 years. * SLE patients fulfilling the SLE International Collaborating Clinics (SLICC) classification criteria and matched controls. * Patients cooperative and can answer questions. * Patients who are able and willing to give written informed consent.
Key inclusion criteria (4 listed)
- Aged ≥18 years.
- SLE patients fulfilling the SLE International Collaborating Clinics (SLICC) classification criteria and matched controls.
- Patients cooperative and can answer questions.
- Patients who are able and willing to give written informed consent.
Key exclusion criteria (13 listed)
- • Individuals with other autoimmune diseases.
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 |
|---|---|---|
| renal dopplerdoppler srudy on renal arteries bilaterally , and detection of RI of renal artery | Diagnostic test | group SLE, group control |
Primary outcome
doppler for renal artery
Time frame: 1 year
resistive index of renal artery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Background: PubMed 35932197Alforaih N, Whittall-Garcia L, Touma Z. A Review of Lupus Nephritis. J Appl Lab Med. 2022 Oct 29;7(6):1450-1467. doi: 10.1093/jalm/jfac036.
- Background: PubMed 36407159Ameer MA, Chaudhry H, Mushtaq J, Khan OS, Babar M, Hashim T, Zeb S, Tariq MA, Patlolla SR, Ali J, Hashim SN, Hashim S. An Overview of Systemic Lupus Erythematosus (SLE) Pathogenesis, Classification, and Management. Cureus. 2022 Oct 15;14(10):e30330. doi: 10.7759/cureus.30330. eCollection 2022 Oct.
- Background: PubMed 31974366Anders HJ, Saxena R, Zhao MH, Parodis I, Salmon JE, Mohan C. Lupus nephritis. Nat Rev Dis Primers. 2020 Jan 23;6(1):7. doi: 10.1038/s41572-019-0141-9.
- Background: PubMed 35589256Anstee QM, Castera L, Loomba R. Impact of non-invasive biomarkers on hepatology practice: Past, present and future. J Hepatol. 2022 Jun;76(6):1362-1378. doi: 10.1016/j.jhep.2022.03.026.
- Individual participant dataSharing planned: Undecided
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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.
Esam M Abualfadl, professor contact
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 Lupus Nephritis, run by Sohag University 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 4 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 8 Oct 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Doaa R Abdelkarim, resident (01027673294, doaa_rabea_post@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
doppler for renal artery (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06631404, which also lists 4 linked publications.
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 8 Oct 2024.