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Not yet recruitingNCT07780045Updated Aug 24, 2026

SII and SIRI as Prognostic Biomarkers in Lupus Nephritis

An observational study in Lupus Nephritis, Systemic Lupus Erythematosus and Kidney Diseases, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-08-24.

Sponsored by Assiut University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years to 70 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 22 studies in Lupus Nephritis by Assiut University — 17 open to participants now, 17 under way, none of them phase 3. Lupus Nephritis · Assiut University.

Planned enrollment
6th of 21
100 · median 96
Started
2026
with 7 others
Observational
21 of 22
17 open now
Primary completion
2027-08
later than 11 of 16 live
Registered
20th of 22
by date

Among the 22 studies in Lupus Nephritis by Assiut University, this one is the 6th largest by planned enrollment of the 21 observational ones, is one of 8 that started in 2026, is one of 21 observational ones, reaches primary completion later than 11 of the 16 other live ones, and was the 20th registered.

By phase

22 studies; the count open now beside each. This study's row is marked.

Observationalthis study21 · 17 open
Phase 31 · 0 open

By the year they started

First in 2019; this study’s year is marked. 8 started in 2026.

Size and results

Median enrollment 60 across the 1 interventional studies, 96 across the 21 observational. None of them has completed or been terminated yet.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 22 studies in Lupus Nephritis by Assiut University, or all of them as a file.
02

Study 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.

Read the detailed description

Lupus nephritis (LN) is a common and serious manifestation of systemic lupus erythematosus (SLE) that can lead to progressive renal damage and end-stage renal disease. Current assessment of disease activity and prognosis relies mainly on proteinuria, serum creatinine, estimated glomerular filtration rate (eGFR), and kidney biopsy, which is invasive and not always feasible for repeated monitoring.

Simple blood count-derived inflammatory indices, such as the Systemic Immune-Inflammation Index (SII) and the Systemic Inflammation Response Index (SIRI), have recently emerged as potential biomarkers of systemic inflammation. These indices are inexpensive, readily available, and may reflect disease activity and renal risk in lupus nephritis. However, their prognostic value remains incompletely established, particularly in prospective settings.

This prospective observational study will evaluate the ability of SII and SIRI to monitor disease activity and predict renal flares and outcomes in patients with lupus nephritis over a 12-month follow-up period.

03

Conditions studied

  • Lupus Nephritis
  • Systemic Lupus Erythematosus
  • Kidney Diseases

Keywords

  • Systemic Immune-Inflammation Index SII
  • Systemic Inflammation Response Index SIRI
  • Lupus Nephritis Biomarkers
04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability 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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Active infection, sepsis, or other concurrent inflammatory or conditions
  • 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Target follow-up
12 Months
Patient registry
Yes
06

What researchers measure

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.

    Time frame: Baseline, 6 months, and 12 months

Secondary outcomes

  1. Association of SII and SIRI with renal function parameters

    Association between SII and SIRI levels and renal function parameters including serum creatinine, eGFR, and proteinuria.

    Time frame: Baseline, 6 months, and 12 months

  2. Predictive value of SII and SIRI for renal flares

    Ability of baseline and follow-up SII and SIRI values to predict the occurrence of renal flares

    Time frame: 12 months

  3. Association of SII and SIRI with clinical outcomes

    Relationship between SII and SIRI levels and short-term clinical outcomes including renal remission or disease progression.

    Time frame: 12 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 37300586 ↗
  • 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. PubMed 41098718 ↗
  • 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. PubMed 39958362 ↗
  • Gladman DD, Ibanez D, Urowitz MB. Systemic lupus erythematosus disease activity index 2000. J Rheumatol. 2002 Feb;29(2):288-91. PubMed 11838846 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Aug 2026; primary completion for Aug 2027, 12 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 19, 2026
First posted
Aug 21, 2026
StartEst.
Aug 19, 2026
Primary completionEst.
Aug 19, 2027
CompletionEst.
Oct 19, 2027
Last update
Aug 24, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07780045
Lead sponsor
Assiut University
Responsible party
Abobakr Ahmed Bakr Madkour (Resident, Assiut University) — Principal investigator
First posted
Aug 21, 2026
Start date
Aug 19, 2026 (estimated)
Primary completion
Aug 19, 2027 (estimated)
Completion
Oct 19, 2027 (estimated)
Last update
Aug 24, 2026

Study contacts

Abobakr A bakr, Resident
Contact
AbuBakr.18313431@med.aun.edu.eg
01100440065 ext. 01100440065

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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