The Expression Profile of New Complement Components in Childhood Lupus Nephritis

• Sponsor: Assiut University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05082363
• Collaborator: (none)
• Enrollment: 30
• Anticipated Duration (Months): 9

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Lupus Nephritis	Combination Product: C4d evaluation in lupus nephritis in serum and renal tissue

Detailed 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

Study Design

• Study Type: Observational
• Anticipated Enrollment: 30 participants
• Observational Model: Other
• Time Perspective: Cross-Sectional
• Official Title: The Expression Profile of New Complement Components in Childhood Lupus Nephritis
• Anticipated Study Start Date: Nov 1, 2021
• Anticipated Primary Completion Date: Jan 1, 2022
• Anticipated Study Completion Date: Aug 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
systemic lupus wth renal affection pt diagnosed with lupus nephritis	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)
systemic lupus without renal affection pt diagnosed as systemic lupus without renal affection	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)

Outcome Measures

Primary Outcome Measures

1. Evaluation of C4d in lupus nephritis in children [2 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Year to 18 Years
• Sexes Eligible for Study: All

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.

• Responsible Party: Aya Khalifa, principle investigator, Assiut University
• ClinicalTrials.gov Identifier: NCT05082363
• Other Study ID Numbers: LNC4D
• First Posted: Oct 18, 2021
• Last Update Posted: Oct 18, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Additional relevant MeSH terms: Nephritis; Lupus Nephritis

Study Results

No Results Posted as of Oct 18, 2021