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

Overview

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).

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

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: November 1, 2022

Interventions

  • 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.

Arms, Groups and Cohorts

  • Participants with Lupus Nephritis

Clinical Trial Outcome Measures

Primary Measures

  • Number of participants with demographic characteristics
    • Time Frame: Up to 1 year
  • Number of participants with clinical manifestations of Lupus Nephritis
    • Time Frame: Up to 1 year
  • Number of participants with comorbidities
    • Time Frame: Up to 1 year
  • Severity of Lupus Nephritis in participants
    • Time Frame: Up to 1 year
  • Number of participants with treatments for lupus nephritis
    • Time Frame: Up to 1 year
  • 36-Item Short Form Health Survey (SF-36) total score
    • Time Frame: Up to 1 year
    • 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.

Secondary Measures

  • Number of participants with refractory Lupus Nephritis
    • Time Frame: Up to 1 year
  • Change from Baseline in anti-nuclear antibody
    • Time Frame: Baseline and up to 1 year
  • Change from Baseline in antibody to double-stranded deoxyribonucleic acid test (anti-dsDNA antibody)
    • Time Frame: Baseline and up to 1 year
  • Change from Baseline in complement (C3 and C4) levels
    • Time Frame: Baseline and up to 1 year
  • Number of participants with renal remission
    • Time Frame: 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)
    • Time Frame: Baseline and 1 year
    • 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.
  • Number of participants with healthcare resource utilization (HCRU)
    • Time Frame: Up to 1 year
  • Direct medical costs associated with lupus nephritis management
    • Time Frame: Up to 1 year
  • Number of participants with difference in treatment patterns
    • Time Frame: Up to 1 year

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • GlaxoSmithKline
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • GSK Clinical Trials, Study Director, GlaxoSmithKline
  • Overall Contact(s)
    • US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com

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