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

NCT04971590 | Completed Results

• 1 other identifier: 216989
• Study Type: observational
• Target: 193
• Locations: 4 countries
• Sites: 6

Brief Summary

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).

Conditions

Systemic Lupus Erythematosus

Keywords

LUNELORD; Systemic lupus erythematosus; Lupus nephritis; Organ damage; Gulf countries; Real-world

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (7)

• Number of Participants With Refractory Lupus Nephritis

  Up to 12 months

• Number of Participants With Abnormal Findings for Serological Markers

  At 3, 6, 9 and 12 months

• Number of Participants With Renal Remission That Were Associated With Clinical Factors, Biomarkers, and Treatments

  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

  Baseline (Day 1) and at 12 months

• Number of Participants With Hospitalizations and Intensive Care Unit (ICU) Hospitalizations

  Up to 12 months

Study Arms (1)

Participants with Lupus Nephritis

Other: Participant completed survey; Other: Medical chart review

Interventions

Participant completed survey OTHER

Participants will be required to complete the participant survey.

Participants with Lupus Nephritis

Medical chart review OTHER

Data will be collected from medical charts of participants.

Participants with Lupus Nephritis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (6)

GSK Investigational Site

Shweikh, Kuwait

Location

GSK Investigational Site

Bawshar, Oman

Location

GSK Investigational Site

Alrayyan, Qatar

Location

GSK Investigational Site

Abu Dhabi, United Arab Emirates

Location

GSK Investigational Site

Al Ain City, United Arab Emirates

Location

GSK Investigational Site

Dubai, United Arab Emirates

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Lupus Nephritis

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Limitations and Caveats

Healthcare Resource Utilization and costs: 1. Relevant data was collected in local currency, as United States Dollar and local currency were used based on a fixed annual rate. 2. In order to map the costs at Government hospitals, these hospitals were asked to list the costs of their services and to describe consultation fees of their salaried healthcare practitioners. 3. Assumptions were made on out-of-pocket expenses that were not recorded.

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2021
• First Posted: July 21, 2021
• Study Start: September 14, 2021
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: January 22, 2026
• Results First Posted: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

OM (1); KU (1); AE (3); QA (1)