C-CAR168 CAR T-Cell Therapy for the Treatment of Lupus Nephritis Refractory to Standard Therapy
NCT07729826
Autoimmune Diseases, Connective Tissue Diseases
View Trial DetailsNCT Number: NCT07783711
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
Trial opening soon.
Get Notified18 year–70 year
All sexes
Observational
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.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 8 weeks
Contact information is provided by the study sponsor or research team.
Alaa Omar Ahmed
CONTACT
Khaled Samir Malak
CONTACT
Khaled Samir Malak Nashed
Other
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