NCT06491602

Brief 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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 24, 2024

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

July 1, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 9, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 24, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 24, 2025

Completed
Last Updated

July 9, 2024

Status Verified

July 1, 2024

Enrollment Period

1 year

First QC Date

July 1, 2024

Last Update Submit

July 1, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • remission of LN

    acute on top of chronic

    1 year

  • progress to CKD

    affection of kidney become perment

    1 year

Interventions

renal biobsyDIAGNOSTIC_TEST

analsis of renal biobsy and decide grade of renal affection

Also known as: abdomial us, laboratory investigation for lupus nephritis

Eligibility Criteria

Age1 Month - 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

all children with diagnostic criteria of SLE atteding to pediatric rheumatology and immunology clinic

You may qualify if:

  • \- aim to include all children fulfilling diagnostic criteria

You may not qualify if:

  • children with other rheumatological disorder neonates chidren with other nephrolgy disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag university Hospital

Sohag, Sohag, Egypt

RECRUITING

Related Publications (4)

  • Tsokos GC. Systemic lupus erythematosus. N Engl J Med. 2011 Dec 1;365(22):2110-21. doi: 10.1056/NEJMra1100359. No abstract available.

    PMID: 22129255BACKGROUND
  • 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.

    PMID: 22847366BACKGROUND
  • 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.

    PMID: 33826705BACKGROUND
  • 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.

    PMID: 18346514BACKGROUND

MeSH Terms

Conditions

Lupus Nephritis

Condition Hierarchy (Ancestors)

GlomerulonephritisNephritisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLupus Erythematosus, SystemicConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Central Study Contacts

dr monser M Mohammed, assistant professor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident-pediatric department-sohag hospital university

Study Record Dates

First Submitted

July 1, 2024

First Posted

July 9, 2024

Study Start

June 24, 2024

Primary Completion

June 24, 2025

Study Completion

June 24, 2025

Last Updated

July 9, 2024

Record last verified: 2024-07

Locations