NCT07780045

Brief Summary

This prospective observational study aims to evaluate the prognostic utility of the Systemic Immune-Inflammation Index (SII) and Systemic Inflammation Response Index (SIRI) as novel inflammatory biomarkers for monitoring disease activity and predicting renal progression, flares, and outcomes in patients with lupus nephritis.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
14mo left

Started Aug 2026

Status
not yet recruiting

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

Study Progress3%
Aug 2026Oct 2027

First Submitted

Initial submission to the registry

August 19, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

August 19, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 21, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 19, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 19, 2027

Last Updated

August 24, 2026

Status Verified

August 1, 2026

Enrollment Period

1 year

First QC Date

August 19, 2026

Last Update Submit

August 21, 2026

Conditions

Lupus NephritisSystemic Lupus ErythematosusKidney Diseases

Keywords

Systemic Immune-Inflammation Index SIISystemic Inflammation Response Index SIRILupus Nephritis Biomarkers

Outcome Measures

Primary Outcomes (1)

  • Correlation of SII and SIRI with disease activity

    Correlation between Systemic Immune-Inflammation Index (SII) and Systemic Inflammation Response Index (SIRI) levels with disease activity assessed by SLEDAI-2K and Renal SLEDAI scores.

    Baseline, 6 months, and 12 months

Secondary Outcomes (3)

  • Association of SII and SIRI with renal function parameters

    Baseline, 6 months, and 12 months

  • Predictive value of SII and SIRI for renal flares

    12 months

  • Association of SII and SIRI with clinical outcomes

    12 months

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adults with lupus nephritis attending the Internal Medicine Department (Nephrology and Rheumatology units) at Assiut University Hospitals who meet the study eligibility criteria.

You may qualify if:

  • Age ≥ 18 years
  • Diagnosis of systemic lupus erythematosus according to the 2019 EULAR/ACR classification criteria
  • Confirmed lupus nephritis according to ISN/RPS classification

You may not qualify if:

  • Active infection, sepsis, or other concurrent inflammatory or autoimmune conditions
  • Malignancy or hematologic disorders affecting blood cell counts
  • Pregnancy
  • Use of medications significantly affecting blood counts (such as recent chemotherapy or G-CSF)
  • Incomplete medical records or anticipated loss to follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Wang DC, Xu WD, Wang SN, Wang X, Leng W, Fu L, Liu XY, Qin Z, Huang AF. Lupus nephritis or not? A simple and clinically friendly machine learning pipeline to help diagnosis of lupus nephritis. Inflamm Res. 2023 Jun;72(6):1315-1324. doi: 10.1007/s00011-023-01755-7. Epub 2023 Jun 10.

    PMID: 37300586BACKGROUND

  • Zhang X, Chen Y, Fan Y, Gao D, Zhang Z. NLR (neutrophil to lymphocyte ratio), PLR (platelet to lymphocyte ratio), and SII (systemic immune-inflammation index) reflect disease activity and renal remission in patients with lupus nephritis. Front Immunol. 2025 Sep 30;16:1646276. doi: 10.3389/fimmu.2025.1646276. eCollection 2025.

    PMID: 41098718BACKGROUND

  • Yang CH, Wang XY, Zhang YH, Ding N. SIRI and SII as potential biomarkers of disease activity and lupus nephritis in systemic lupus erythematosus. Front Immunol. 2025 Jan 31;16:1530534. doi: 10.3389/fimmu.2025.1530534. eCollection 2025.

    PMID: 39958362BACKGROUND

  • Gladman DD, Ibanez D, Urowitz MB. Systemic lupus erythematosus disease activity index 2000. J Rheumatol. 2002 Feb;29(2):288-91.

    PMID: 11838846BACKGROUND

MeSH Terms

Conditions

Lupus NephritisLupus Erythematosus, SystemicKidney Diseases

Condition Hierarchy (Ancestors)

GlomerulonephritisNephritisUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Central Study Contacts

Abobakr A bakr, Resident

CONTACT

01100440065AbuBakr.18313431@med.aun.edu.eg

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

August 19, 2026

First Posted

August 21, 2026

Study Start

August 19, 2026

Primary Completion (Estimated)

August 19, 2027

Study Completion (Estimated)

October 19, 2027

Last Updated

August 24, 2026

Record last verified: 2026-08