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The Expression Profile of New Complement Components in Childhood Lupus Nephritis

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ClinicalTrials.gov Identifier: NCT05082363
Recruitment Status : Not yet recruiting
First Posted : October 18, 2021
Last Update Posted : October 18, 2021
Sponsor:
Information provided by (Responsible Party):
Aya Khalifa, Assiut University

Study Description
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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
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
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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: The Expression Profile of New Complement Components in Childhood Lupus Nephritis
Estimated Study Start Date : November 2021
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : August 2022

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Groups and Cohorts
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Group/Cohort 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
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Primary Outcome Measures :
  1. Evaluation of C4d in lupus nephritis in children [ Time Frame: 2 years ]

Eligibility Criteria
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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population

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.
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05082363


Contacts
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Contact: Aya Khalifa, assisstant lecterurer +201016228446 Dr.ayaahmedkhlifa@gmail.com
Contact: Ahalam Ali, assisstant professor 201006807866 dr.ahlam_ali@yahoo.com

Sponsors and Collaborators
Assiut University
More Information
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Publications:

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Responsible Party: Aya Khalifa, principle investigator, Assiut University
ClinicalTrials.gov Identifier: NCT05082363    
Other Study ID Numbers: LNC4D
First Posted: October 18, 2021    Key Record Dates
Last Update Posted: October 18, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Nephritis
Lupus Nephritis
Kidney Diseases
Urologic Diseases
Glomerulonephritis
 Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases