Lupus Nephritis (LN)NCT07783711
Predictors of ICU Admission and In-Hospital Mortality in Hospitalized Patients With Lupus Nephritis: The Prognostic Value of Neutrophil-to-Lymphocyte Ratio and C Reactive Protein to Serum Albumin Ratio
An observational study of Lupus Nephritis (LN), run by Khaled Samir Malak Nashed.
Trial summary
To identify clinical and laboratory predictors of ICU admission and in-hospital mortality among hospitalized adults with lupus nephritis by evaluating the prognostic performance of NLR and CAR, comparing them with CRP and albumin using ROC analysis, determining optimal cutoff values, and identifying independent… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lupus Nephritis (LN)
- How many people
- 55 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to 1 Oct 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Adult, Older adult
Study population: Hospitalized adult patients with Lupus Nephritis.
Who may be able to join
- Age ≥18 years.
- Diagnosis of systemic lupus erythematosus according to the 2019 EULAR/ACR Classification Criteria.
- Biopsy-proven lupus nephritis or clinically diagnosed lupus nephritis according to the treating nephrologist based on clinical, laboratory and immunological findings.
- Hospitalization because of active lupus nephritis or complications related to lupus nephritis.
- Provision of written informed consent.
Who cannot join
- Age below 18 years.
- Previous kidney transplantation.
- Maintenance dialysis for more than three months before hospital admission.
- Active malignancy.
- Pregnancy.
- Refusal to participate
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
To identify clinical and laboratory predictors of ICU admission and in-hospital mortality among hospitalized adults with lupus nephritis by evaluating the prognostic performance of NLR and CAR, comparing them with CRP and albumin using ROC analysis, determining optimal cutoff values, and identifying independent predictors through multivariable logistic regression
Read the detailed description
Systemic lupus erythematosus (SLE) is a chronic multisystem autoimmune disease characterized by immune dysregulation, autoantibody production, immune complex deposition, and complement activation, leading to inflammation and irreversible organ damage. Despite advances in immunosuppressive therapy, SLE remains associated with significant morbidity, frequent hospitalizations, and premature mortality. Lupus nephritis (LN), affecting approximately 40-60% of patients with SLE, is one of its most severe manifestations and a major cause of chronic kidney disease, endstage kidney disease, cardiovascular complications, recurrent hospitalizations, and death. Hospitalized patients with LN often develop severe disease flares, acute kidney injury, nephrotic syndrome, infections, pulmonary hemorrhage, neuropsychiatric lupus, thrombotic microangiopathy, or cardiovascular complications requiring intensive care, where mortality remains high Early identification of patients at risk of clinical deterioration is essential to improve monitoring and optimize treatment. Several demographic, clinical, and laboratory factors have been linked to poor outcomes, including older age, active disease, infection, impaired kidney function, thrombocytopenia, hypocomplementemia, and hypoalbuminemia. However, most available studies are retrospective or limited to selected SLE populations.
Recently, inexpensive inflammatory biomarkers derived from routine laboratory tests have gained attention. The neutrophil-to-lymphocyte ratio (NLR) reflects systemic inflammatory activity and has been associated with disease activity, acute kidney injury, ICU admission, and mortality. The C-reactive protein-to-albumin ratio (CAR), combining inflammatory and nutritional status, has also demonstrated prognostic value in inflammatory and critically ill patients.
This prospective observational cohort study aims to identify the clinical and laboratory predictors of ICU admission and in-hospital mortality among hospitalized patients with lupus nephritis, with particular emphasis on evaluating the prognostic performance of NLR and CAR as simple, readily available biomarkers for early risk stratification.
- Conditions
- Lupus Nephritis (LN)
- Keywords
- NLR CAR
- Medical subject headings
- Lupus Nephritis
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants of ICU admission or In-hospital mortality.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study startSep 2026 (estimated)
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lupus Nephritis (LN)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Khaled Samir Malak Nashed
- Sponsor type
- University, hospital or other
- Collaborators
- Assiut University
- Responsible party
- Sponsor-investigator, Khaled Samir Malak Nashed, Assiut University
- Investigators
- Samir Kamal, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07783711
- Sponsor's protocol ID
- Prognosis in lupus nephritis
- Status last verified
- Aug 2026
- First submitted
- 21 Aug 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chen Y, Wu X, Chen X, Li M, Luo C, Shi Y, Li J, Wu L. Correlations of baseline neutrophil-lymphocyte ratio with prognosis of patients with lupus nephritis: A single-center experience. Rheumatol Immunol Res. 2023 Dec 19;4(4):196-203. doi: 10.2478/rir-2023-0029. eCollection 2023 Dec.
PubMed 38125645
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of ICU Admission and In-Hospital Mortality in Hospitalized Patients With Lupus Nephritis: The Prognostic Value of Neutrophil-to-Lymphocyte Ratio and C Reactive Protein to Serum Albumin Ratio
- ClinicalTrials.gov ID
- NCT07783711
- Acronym / sponsor ID
- Prognosis in lupus nephritis
- Conditions
- Lupus Nephritis (LN)
- Keywords
- NLR CAR
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Khaled Samir Malak NashedUniversity, hospital or other
- Collaborators
- Assiut University
- Study start
- Sep 2026 (estimated)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 25 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To identify clinical and laboratory predictors of ICU admission and in-hospital mortality among hospitalized adults with lupus nephritis by evaluating the prognostic performance of NLR and CAR, comparing them with CRP and albumin using ROC analysis, determining optimal cutoff values, and identifying independent predictors through multivariable logistic regression
Detailed description
Systemic lupus erythematosus (SLE) is a chronic multisystem autoimmune disease characterized by immune dysregulation, autoantibody production, immune complex deposition, and complement activation, leading to inflammation and irreversible organ damage. Despite advances in immunosuppressive therapy, SLE remains associated with significant morbidity, frequent hospitalizations, and premature mortality. Lupus nephritis (LN), affecting approximately 40-60% of patients with SLE, is one of its most severe manifestations and a major cause of chronic kidney disease, endstage kidney disease, cardiovascular complications, recurrent hospitalizations, and death. Hospitalized patients with LN often develop severe disease flares, acute kidney injury, nephrotic syndrome, infections, pulmonary hemorrhage, neuropsychiatric lupus, thrombotic microangiopathy, or cardiovascular complications requiring intensive care, where mortality remains high Early identification of patients at risk of clinical deterioration is essential to improve monitoring and optimize treatment. Several demographic, clinical, and laboratory factors have been linked to poor outcomes, including older age, active disease, infection, impaired kidney function, thrombocytopenia, hypocomplementemia, and hypoalbuminemia. However, most available studies are retrospective or limited to selected SLE populations.
Recently, inexpensive inflammatory biomarkers derived from routine laboratory tests have gained attention. The neutrophil-to-lymphocyte ratio (NLR) reflects systemic inflammatory activity and has been associated with disease activity, acute kidney injury, ICU admission, and mortality. The C-reactive protein-to-albumin ratio (CAR), combining inflammatory and nutritional status, has also demonstrated prognostic value in inflammatory and critically ill patients.
This prospective observational cohort study aims to identify the clinical and laboratory predictors of ICU admission and in-hospital mortality among hospitalized patients with lupus nephritis, with particular emphasis on evaluating the prognostic performance of NLR and CAR as simple, readily available biomarkers for early risk stratification.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Hospitalized adult patients with Lupus Nephritis.
Key inclusion criteria (5 listed)
- Age ≥18 years.
Key exclusion criteria (6 listed)
- Age below 18 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of participants of ICU admission or In-hospital mortality.
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Background: PubMed 38125645Chen Y, Wu X, Chen X, Li M, Luo C, Shi Y, Li J, Wu L. Correlations of baseline neutrophil-lymphocyte ratio with prognosis of patients with lupus nephritis: A single-center experience. Rheumatol Immunol Res. 2023 Dec 19;4(4):196-203. doi: 10.2478/rir-2023-0029. eCollection 2023 Dec.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Samir Kamal study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Lupus Nephritis (LN), run by Khaled Samir Malak Nashed.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Khaled Samir Malak (+201554715247, Khaled.18313263@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants of ICU admission or In-hospital mortality. (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07783711, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.