Study to Assess Demographic, Pharmacologic, Biomarker, Clinical Features and Quality of Life (QoL) of Participants With Lupus Nephritis

Study Overview
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Brief Summary
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This is a multicenter prospective study to assess clinical characteristics, demographics, treatment and health-related quality of life (HRQoL) of lupus nephritis (LN) participants across 5 Gulf countries (United Arab Emirates [UAE], Qatar, Bahrain, Kuwait and Oman).

Official Title
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LUNELORD: A Descriptive, Prospective Study to Assess Demographic, Pharmacologic, Biomarker, Clinical Features and QoL of Patients With LUpus NEphritis and Long-term ORgan Damage

Conditions
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Systemic Lupus Erythematosus

Intervention / Treatment
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* Other: Participant completed survey
* Other: Medical chart review


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: More than or equal to 18 years of age Clinician diagnosed LN participants. At least one visit to the investigational center during 12 months prior to the baseline visit, recorded in medical documentation. Literacy in English or Arabic allowing to fully comprehend the written informed consent and study-specific patient reported questionnaires. Exclusion Criteria: Incomplete medical records to be able to assess the disease severity or absence of any of the following renal laboratory results from the medical record within the last twelve months: a. Urinary protein to creatinine ratio (UPCR) or 24-hour proteinuria or urine sediment (activity). b. Serum creatinine or estimated glomerular filtration rate (eGFR); or measured glomerular filtration rate (GFR), if eGFR is not available. Current or medical history of: a. Congenital or acquired immunodeficiency. b. Malignancy in active treatment phase. c. Acute viral infection, such as human immunodeficiency virus (HIV) infection, requiring hospitalization.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants with Lupus Nephritis<br> | Other: Participant completed survey<br>* Participants will be required to complete the participant survey.<br>Other: Medical chart review<br>* Data will be collected from medical charts of participants.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with demographic characteristics |  | Up to 1 year | 
| Number of participants with clinical manifestations of Lupus Nephritis |  | Up to 1 year | 
| Number of participants with comorbidities |  | Up to 1 year | 
| Severity of Lupus Nephritis in participants |  | Up to 1 year | 
| Number of participants with treatments for lupus nephritis |  | Up to 1 year | 
| 36-Item Short Form Health Survey (SF-36) total score | The SF-36 is a 36-item QoL questionnaire covering 8 health domains. Scores for each domain range from 0 to 100, with a higher score defining a more favorable health state. | Up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with refractory Lupus Nephritis |  | Up to 1 year | 
| Change from Baseline in anti-nuclear antibody |  | Baseline and up to 1 year | 
| Change from Baseline in antibody to double-stranded deoxyribonucleic acid test (anti-dsDNA antibody) |  | Baseline and up to 1 year | 
| Change from Baseline in complement (C3 and C4) levels |  | Baseline and up to 1 year | 
| Number of participants with renal remission |  | Up to 1 year | 
| Changes in the SF-36 physical and mental components score and the total scores at one year (Scores on a scale) | The SF-36 is a 36-item QoL questionnaire covering 8 health domains. Scores for each domain range from 0 to 100, with a higher score defining a more favorable health state. | Baseline and 1 year | 
| Number of participants with healthcare resource utilization (HCRU) |  | Up to 1 year | 
| Direct medical costs associated with lupus nephritis management |  | Up to 1 year | 
| Number of participants with difference in treatment patterns |  | Up to 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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LUNELORD, Systemic lupus erythematosus, Lupus nephritis, Organ damage, Gulf countries, Real-world