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

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

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).

Study Overview

• Status: Completed
• Conditions: Systemic Lupus Erythematosus
• Intervention / Treatment: Other: Participant completed survey; Other: Medical chart review

• Study Type: Observational
• Enrollment (Actual): 193

Contacts and Locations

Study Locations

• Kuwait
  • Shweikh, Kuwait
    • GSK Investigational Site
• Oman
  • Bawshar, Oman
    • GSK Investigational Site
• Qatar
  • Alrayyan, Qatar
    • GSK Investigational Site
• United Arab Emirates
  • Abu Dhabi, United Arab Emirates
    • GSK Investigational Site
  • Al Ain City, United Arab Emirates
    • GSK Investigational Site
  • Dubai, United Arab Emirates
    • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants with lupus nephritis as defined by physician per participants hospital records prior to the enrolment visit or at diagnosis.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Participants with Lupus Nephritis	Other: Participant completed survey; Participants will be required to complete the participant survey.; Other: Medical chart review; Data will be collected from medical charts of participants.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Categorized by Demographic Characteristics	Number of participants categorized by demographic characteristics including - health insurance coverage (yes, no), employment status (full time, part-time, housewife, not working, other, retired, self-employment), cigarette smoking status (current smoker, ex-smoker, non-smoker, unknown) and alcohol consumption (current, former, never, unknown) has been presented.	At Baseline (Day 1)
Number of Participants With Active Clinical Manifestations of Lupus Nephritis	The active clinical manifestations included pedal edema, serositis, hair loss, decreased urine output, malar rash, discoid rash, photosensitive rash, joint pain/arthritis, hypertension, oral ulcer, seizure, psychosis, proteinuria, microscopic hematuria, anemia, thrombocytopenia, renal failure, leukopenia, other (autoimmune hepatitis, raised Serum creatinine with estimated glomerular filtration rate [eGFR] 59 milliliters per minute [ml/min]/1.73 meter square [m^2]). Participants may have more than 1 active clinical manifestations of Lupus Nephritis.	Up to 12 months
Number of Participants With Comorbidities	Participants with comorbidities (such as antiphospholipid syndrome/thrombotic microangiopathy, obesity, cardiovascular disease, diabetes) observed since the date of first diagnosis of lupus nephritis has been presented.	Up to 12 months
Number of Participants With Severe Lupus Nephritis	Severe lupus nephritis was defined as participants with Systemic lupus erythematosus disease activity index 2000 (SLEDAI-2K) score greater than or equal to (>=) 10. SLEDAI-2K score was the sum of all 24 individual items from the SLEDAI-2K. The total score ranges from 0 (no disease activity) to 105 (all 24 descriptors present simultaneously). A higher score indicates a more significant degree of disease activity.	Up to 12 months
Number of Participants Categorized by Treatments for Lupus Nephritis	Number of participants categorized by treatments for lupus nephritis including prednisone, chloroquine, hydroxychloroquine, azathioprine, belimumab, tacrolimus, cyclosporine, voclosporin, cyclophosphamide, mycophenolate mofetil, methotrexate, and rituximab has been presented. Participants may have received more than 1 treatment for lupus nephritis.	At Baseline (Day 1)
Short Form Health Survey (SF-36) Health-related Quality of Life Domain Score	The 36-Item Short Form Health Survey (SF-36) is a 36-item Health-Related Quality of Life (HRQoL) questionnaire covering 8 health domains: physical functioning, Pain, Role limitations due to physical health, Role limitations due to emotional problems, emotional well-being, Social Functioning, energy/fatigue, and General Health. The individual question items are first summed for each item under the various sections. Then, those domain scores were weighted to a scale ranging between 0 to 100, where higher score represents better health. Individual domain scores have been presented.	At Baseline (Day 1)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Refractory Lupus Nephritis	Refractory systemic lupus nephritis was defined as inefficacy of cyclophosphamide, use of rituximab, splenectomy, or inefficacy of >=2 immunosuppressives (methotrexate, leflunomide, abatacept, anti-tumor necrosis factor [anti-TNF], azathioprine, mycophenolate mofetil, and/or mycophenolic acid).	Up to 12 months
Number of Participants With Abnormal Findings for Serological Markers	Number of participants with abnormal findings for serological markers (including anti-nuclear antibody, anti-double-stranded deoxyribonucleic acid [dsDNA] antibody and complement levels [C3, C4]) has been presented. Abnormal values were determined by the investigator.	At 3, 6, 9 and 12 months
Number of Participants With Renal Remission That Were Associated With Clinical Factors, Biomarkers, and Treatments	Renal remission was defined as proteinuria of <0.7 grams per day (g/d) or <0.5g/d or at physicians' discretion. Number of participants with renal remission that were associated with clinical factors, biomarkers, and treatments has been presented.	Up to 12 months
Percent Change From Baseline in SF-36 Scores for Each Health Domain:Physical Functioning, Pain, Role Limitations Due to Physical Health, Role Limitations Due to Emotional Problem, Emotional Well-being, Social Functioning, Energy/Fatigue and General Health	The 36-Item Short Form Health Survey (SF-36) is a 36-item HRQoL questionnaire covering 8 health domains: physical functioning, pain, role limitations due to physical health, role limitations due to emotional problems, emotional well-being, social functioning, energy/fatigue, and general Health. The individual question items are first summed for each item under the various sections. Then, those domain scores were weighted to a scale ranging between 0 to 100, where higher score represents better health. Baseline was considered as Day 1. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value (at 12 months). Percent change from Baseline was calculated by dividing change from Baseline value by Baseline value and multiplying it by 100. Percent change from Baseline values of individual domain scores have been presented.	Baseline (Day 1) and at 12 months
Number of Participants With Hospitalizations and Intensive Care Unit (ICU) Hospitalizations	Number of participants with hospitalizations and ICU hospitalizations has been presented.	Up to 12 months
Direct Medical Costs Associated With Lupus Nephritis Management	The direct medical costs of hospitalization and ICU hospitalization per participant associated with lupus nephritis management in United States dollars (USD) of United Arab Emirates (UAE), Kuwait, Qatar, and Oman were analyzed. Costs are described in local currency of each country and converted in USD dollars using the average exchange rate for each local currency versus USD in 2023. Direct medical costs associated with lupus nephritis management have been reported as USD.	Up to 12 months
Number of Participants With Treatment for Lupus Nephritis by Sector (Public or Private Sector)	Number of participants with treatments for lupus nephritis (Prednisone, Chloroquine, Hydroxychloroquine, Azathioprine, Belimumab, Tacrolimus, Cyclosporine A, Voclosporin, Cyclophosphamide, Mycophenolate mofetil, Methotrexate, Rituximab) among physicians in the public and private sectors, respectively has been presented. Data has been presented per treatment received either in public sector or private sector up to 12 months. Participants may have received more than 1 treatment.	Up to 12 months

Collaborators and Investigators

• Sponsor: GlaxoSmithKline
• Investigators: Study Director: GSK Clinical Trials, GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2021
• Primary Completion (Actual): October 31, 2024
• Study Completion (Actual): October 31, 2024

Study Registration Dates

• First Submitted: July 12, 2021
• First Submitted That Met QC Criteria: July 12, 2021
• First Posted (Actual): July 21, 2021

Study Record Updates

• Last Update Posted (Actual): January 22, 2026
• Last Update Submitted That Met QC Criteria: January 5, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Systemic lupus erythematosus; Lupus nephritis; Real-world; Organ damage; LUNELORD; Gulf countries
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Glomerulonephritis; Nephritis; Skin and Connective Tissue Diseases; Lupus Erythematosus, Systemic; Lupus Nephritis
• Other Study ID Numbers: 216989

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No