Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Expression Profile of New Complement Components in Childhood Lupus Nephritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date October 7, 2021
First Posted Date October 18, 2021
Last Update Posted Date October 18, 2021
Estimated Study Start Date November 2021
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 7, 2021)
Evaluation of C4d in lupus nephritis in children [ Time Frame: 2 years ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Expression Profile of New Complement Components in Childhood Lupus Nephritis
Official Title The Expression Profile of New Complement Components in Childhood Lupus Nephritis
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).
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 Type Observational
Study Design Observational Model: Other
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Lupus 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)
Study Groups/Cohorts
  • systemic lupus wth renal affection
    pt diagnosed with lupus nephritis
    Intervention: Combination Product: C4d evaluation in lupus nephritis in serum and renal tissue
  • systemic lupus without renal affection
    pt diagnosed as systemic lupus without renal affection
    Intervention: Combination Product: C4d evaluation in lupus nephritis in serum and renal tissue
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: October 7, 2021)
30
Original Estimated Enrollment Same as current
Estimated Study Completion Date August 2022
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 1 Year to 18 Years   (Child, Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Aya Khalifa, assisstant lecterurer +201016228446 Dr.ayaahmedkhlifa@gmail.com
Contact: Ahalam Ali, assisstant professor 201006807866 dr.ahlam_ali@yahoo.com
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT05082363
Other Study ID Numbers LNC4D
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Aya Khalifa, Assiut University
Study Sponsor Assiut University
Collaborators Not Provided
Investigators Not Provided
PRS Account Assiut University
Verification Date October 2021