NCT05082363

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).

Trial Health

35
At Risk

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 Nov 2021

Shorter than P25 for all trials

Status
unknown

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

First Submitted

Initial submission to the registry

October 7, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 18, 2021

Completed
14 days until next milestone

Study Start

First participant enrolled

November 1, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

October 18, 2021

Status Verified

October 1, 2021

Enrollment Period

2 months

First QC Date

October 7, 2021

Last Update Submit

October 7, 2021

Conditions

Lupus Nephritis

Outcome Measures

Primary Outcomes (1)

  • Evaluation of C4d in lupus nephritis in children

    2 years

Study Arms (2)

systemic lupus wth renal affection

pt diagnosed with lupus nephritis

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

Combination Product: C4d evaluation in lupus nephritis in serum and renal tissue

Interventions

C4d evaluation in lupus nephritis in serum and renal tissueCOMBINATION_PRODUCT

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 affectionsystemic lupus wth renal affection

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • Patients in remission.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Martin M, Trattner R, Nilsson SC, Bjork 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.

    PMID: 33133102BACKGROUND

  • 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.

    PMID: 24182857BACKGROUND

  • 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.

    PMID: 24133594BACKGROUND

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

Aya Khalifa, assisstant lecterurer

CONTACT

+201016228446Dr.ayaahmedkhlifa@gmail.com

Ahalam Ali, assisstant professor

CONTACT

201006807866dr.ahlam_ali@yahoo.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

October 7, 2021

First Posted

October 18, 2021

Study Start

November 1, 2021

Primary Completion

January 1, 2022

Study Completion

August 1, 2022

Last Updated

October 18, 2021

Record last verified: 2021-10