The Expression Profile of New Complement Components in Childhood Lupus Nephritis

Lupus Nephritis Clinical Trial

Official title:

The Expression Profile of New Complement Components in Childhood Lupus Nephritis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05082363
• Other study ID #: LNC4D
• Status: Not yet recruiting
• Start date: November 2021
• Est. completion date: August 2022

Study information

• Verified date: October 2021
• Source: Assiut University
• Contact: Aya Khalifa, assisstant lecterurer
• Phone: +201016228446
• Email: Dr.ayaahmedkhlifa[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this study was to evaluate whether C4d is a better biomarker and examine whether C4d plasma levels correlate with treatment response and C4d kidney deposition in systemic lupus erythematosus (SLE) with lupus nephritis (LN).

Description:

Evaluation of C4d in lupus nephritis in children C4d level difference in children with systemic lupus with and without renal affection C4d level in lupus nephritis at activity and after remission Detection of C4d deposition in renal tissue relation to disease activity

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: August 2022
• Est. primary completion date: January 2022
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

Inclusion Criteria:

• This will include children and adolescents who fulfill the 2012 Systemic Lupus International Collaborating Clinics (SLICC)(10) classification criteria of SLE.

• Inclusion Criteria:

• Age younger than 18 years.

• Active SLE with and without renal affection

• Patients with biopsy proven LN according to ISN/RPS classification criteria of Lupus nephritis.

Exclusion Criteria:

• -Patients in remission.

Related Conditions & MeSH terms

• Lupus Nephritis
• Nephritis

Intervention

Combination Product:
• C4d evaluation in lupus nephritis in serum and renal tissue
C4d plasma levels were analyzed by a unique assay specifically detecting C4d arising from complement activation and C4 plasma levels were quantified with competitive ELISA. SLE patients in activitity with and without lupus nephritis In patient with lupus nephritis we will evaluate the C4d after developing remission in the form of reduction of proteinurea less than .5g/g measured as PCR as complete response and less than50% reduction in proteinurea in partial response according to KIDGO guide line Percutaneous renal biopsies were performed in SLE and non-SLE patients under ultrasonographic guidance. 10% formalin-fixed tissue was embedded in paraffin. Four µm-thick sections were stained with hematoxylin and eosin (H&E), periodic acid-Schiff (PAS), periodic acid methenamine silver (PAM), masson-trichrome and polyclonal rabbit anti-human C4d antibody, Renal biopsy specimens of SLE patients were assessed using the most recent modification of the World Health Organization (WHO)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (3)

Bennett M, Brunner HI. Biomarkers and updates on pediatrics lupus nephritis. Rheum Dis Clin North Am. 2013 Nov;39(4):833-53. doi: 10.1016/j.rdc.2013.05.001. Epub 2013 Jul 16. Review. — View Citation

Kim MK, Maeng YI, Lee SJ, Lee IH, Bae J, Kang YN, Park BT, Park KK. Pathogenesis and significance of glomerular C4d deposition in lupus nephritis: activation of classical and lectin pathways. Int J Clin Exp Pathol. 2013 Sep 15;6(10):2157-67. eCollection 2013. — View Citation

Martin M, Trattner R, Nilsson SC, Björk A, Zickert A, Blom AM, Gunnarsson I. Plasma C4d Correlates With C4d Deposition in Kidneys and With Treatment Response in Lupus Nephritis Patients. Front Immunol. 2020 Oct 2;11:582737. doi: 10.3389/fimmu.2020.582737. eCollection 2020. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of C4d in lupus nephritis in children		2 years