Lupus NephritisNCT06491602
A Study of Clinical Characteristics ,Risk Factors and Outcome of Lupus Nephritis Among Children With Systemic Lupus Erthromatousus in Sohag Univeristy Hospital
An observational study of Lupus Nephritis, run by Sohag University at 1 site in Egypt.
Trial summary
systemic lupus erthrematosus is an inflamatory and autoimmune condition characterized by multisystem affection and chronic course with unpredictable flares despite potentially afffecting every oragan . kidney involvment are the most common Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Lupus Nephritis
- What is being tested?
- renal biobsy
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 24 Jun 2024to 24 Jun 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 1 month to 18 years
- All sexes
- Child, Adult
Study population: all children with diagnostic criteria of SLE atteding to pediatric rheumatology and immunology clinic
Who may be able to join
- aim to include all children fulfilling diagnostic criteria
Who cannot join
- children with other rheumatological disorder neonates chidren with other nephrolgy disorder
Trial locations and contacts
1 site in 1 country.
dr monser M Mohammed, assistant professor contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag university Hospital
Sohag, Sohag
Magdy M Amin, professor
About this study
systemic lupus erthrematosus is an inflamatory and autoimmune condition characterized by multisystem affection and chronic course with unpredictable flares despite potentially afffecting every oragan . kidney involvment are the most common
- Conditions
- Lupus Nephritis
- Being tested
- renal biobsy
- 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 biobsyDiagnostic test
Also called abdomial us, laboratory investigation for lupus nephritis
analsis of renal biobsy and decide grade of renal affection
What is being measured
The primary outcome is the main question the study is designed to answer.
remission of LN
acute on top of chronic
Measured: 1 year
progress to CKD
affection of kidney become perment
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 posted9 Jul 2024
- Study start24 Jun 2024
- Primary completion24 Jun 2025 (estimated)
- Study completion24 Jun 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
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Randa Abdelgawad Hussien, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06491602
- Sponsor's protocol ID
- Soh-Med-24-06-22MS
- Status last verified
- Jul 2024
- First submitted
- 1 Jul 2024
- Last updated
- 9 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Tsokos GC. Systemic lupus erythematosus. N Engl J Med. 2011 Dec 1;365(22):2110-21. doi: 10.1056/NEJMra1100359. No abstract available.
PubMed 22129255Hiraki LT, Feldman CH, Liu J, Alarcon GS, Fischer MA, Winkelmayer WC, Costenbader KH. Prevalence, incidence, and demographics of systemic lupus erythematosus and lupus nephritis from 2000 to 2004 among children in the US Medicaid beneficiary population. Arthritis Rheum. 2012 Aug;64(8):2669-76. doi: 10.1002/art.34472.
PubMed 22847366Demir S, Gulhan B, Ozen S, Celegen K, Batu ED, Tas N, Orhan D, Bilginer Y, Duzova A, Ozaltin F, Topaloglu R. Long-term renal survival of paediatric patients with lupus nephritis. Nephrol Dial Transplant. 2022 May 25;37(6):1069-1077. doi: 10.1093/ndt/gfab152.
PubMed 33826705Hiraki LT, Benseler SM, Tyrrell PN, Hebert D, Harvey E, Silverman ED. Clinical and laboratory characteristics and long-term outcome of pediatric systemic lupus erythematosus: a longitudinal study. J Pediatr. 2008 Apr;152(4):550-6. doi: 10.1016/j.jpeds.2007.09.019. Epub 2007 Nov 5.
PubMed 18346514
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Clinical Characteristics ,Risk Factors and Outcome of Lupus Nephritis Among Children With Systemic Lupus Erthromatousus in Sohag Univeristy Hospital
- ClinicalTrials.gov ID
- NCT06491602
- Acronym / sponsor ID
- Soh-Med-24-06-22MS
- Conditions
- Lupus Nephritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 24 Jun 2024 (actual)
- Primary completion
- 24 Jun 2025 (estimated)
- Study completion
- 24 Jun 2025 (estimated)
- First posted
- 9 Jul 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 erthrematosus is an inflamatory and autoimmune condition characterized by multisystem affection and chronic course with unpredictable flares despite potentially afffecting every oragan . kidney involvment are the most common
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- all children with diagnostic criteria of SLE atteding to pediatric rheumatology and immunology clinic
Key inclusion criteria (1 listed)
- aim to include all children fulfilling diagnostic criteria
Key exclusion criteria (1 listed)
- children with other rheumatological disorder neonates chidren with other nephrolgy disorder
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 biobsyAlso: abdomial us, laboratory investigation for lupus nephritisanalsis of renal biobsy and decide grade of renal affection | Diagnostic test | – |
Primary outcome
remission of LN
Time frame: 1 year
acute on top of chronic
progress to CKD
Time frame: 1 year
affection of kidney become perment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2024.
- Background: PubMed 22129255Tsokos GC. Systemic lupus erythematosus. N Engl J Med. 2011 Dec 1;365(22):2110-21. doi: 10.1056/NEJMra1100359. No abstract available.
- Background: PubMed 22847366Hiraki LT, Feldman CH, Liu J, Alarcon GS, Fischer MA, Winkelmayer WC, Costenbader KH. Prevalence, incidence, and demographics of systemic lupus erythematosus and lupus nephritis from 2000 to 2004 among children in the US Medicaid beneficiary population. Arthritis Rheum. 2012 Aug;64(8):2669-76. doi: 10.1002/art.34472.
- Background: PubMed 33826705Demir S, Gulhan B, Ozen S, Celegen K, Batu ED, Tas N, Orhan D, Bilginer Y, Duzova A, Ozaltin F, Topaloglu R. Long-term renal survival of paediatric patients with lupus nephritis. Nephrol Dial Transplant. 2022 May 25;37(6):1069-1077. doi: 10.1093/ndt/gfab152.
- Background: PubMed 18346514Hiraki LT, Benseler SM, Tyrrell PN, Hebert D, Harvey E, Silverman ED. Clinical and laboratory characteristics and long-term outcome of pediatric systemic lupus erythematosus: a longitudinal study. J Pediatr. 2008 Apr;152(4):550-6. doi: 10.1016/j.jpeds.2007.09.019. Epub 2007 Nov 5.
- 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.
dr monser M Mohammed, assistant 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 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: status not confirmed, as of the sponsor's last update on 9 Jul 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 randa A ali, resident (01100128936, randa.abdelgawaad@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
remission of LN (time frame: 1 year). 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?
On the ClinicalTrials.gov record for NCT06491602, 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 9 Jul 2024.