- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06491602
A Study of Clinical Characteristics ,Risk Factors and Outcome of Lupus Nephritis Among Children With Systemic Lupus Erthromatousus in Sohag Univeristy Hospital
July 1, 2024 updated by: Randa Abdelgawad Hussien, Sohag University
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 Overview
Study Type
Observational
Enrollment (Estimated)
30
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
- Name: randa A ali, resident
- Phone Number: 01100128936
- Email: randa.abdelgawaad@med.sohag.edu.eg
Study Contact Backup
- Name: dr monser M Mohammed, assistant professor
- Phone Number: 01026372799
Study Locations
-
-
-
Sohag, Egypt, Sohag
- Recruiting
- Sohag university hospital
-
Contact:
- Magdy M Amin, professor
-
-
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
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
N/A
Sampling Method
Probability Sample
Study Population
all children with diagnostic criteria of SLE atteding to pediatric rheumatology and immunology clinic
Description
Inclusion Criteria:
- aim to include all children fulfilling diagnostic criteria
Exclusion Criteria:
- children with other rheumatological disorder neonates chidren with other nephrolgy disorder
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
remission of LN
Time Frame: 1 year
|
acute on top of chronic
|
1 year
|
|
progress to CKD
Time Frame: 1 year
|
affection of kidney become perment
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Tsokos GC. Systemic lupus erythematosus. N Engl J Med. 2011 Dec 1;365(22):2110-21. doi: 10.1056/NEJMra1100359. No abstract available.
- Hiraki 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.
- Demir 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.
- Hiraki 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.
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)
June 24, 2024
Primary Completion (Estimated)
June 24, 2025
Study Completion (Estimated)
June 24, 2025
Study Registration Dates
First Submitted
July 1, 2024
First Submitted That Met QC Criteria
July 1, 2024
First Posted (Actual)
July 9, 2024
Study Record Updates
Last Update Posted (Actual)
July 9, 2024
Last Update Submitted That Met QC Criteria
July 1, 2024
Last Verified
July 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Autoimmune Diseases
- Kidney Diseases
- Urologic Diseases
- Connective Tissue Diseases
- Glomerulonephritis
- Lupus Erythematosus, Systemic
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Nephritis
- Lupus Nephritis
Other Study ID Numbers
- Soh-Med-24-06-22MS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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.