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

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• United Arab Emirates
  • Dubai, United Arab Emirates
    • Recruiting
    • GSK Investigational Site
    • Principal Investigator: Suad Hannawi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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 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

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2021
• Primary Completion (Anticipated): January 30, 2023
• Study Completion (Anticipated): January 30, 2023

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): April 28, 2022
• Last Update Submitted That Met QC Criteria: April 21, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Systemic lupus erythematosus; Lupus nephritis; Real-world; Organ damage; LUNELORD; Gulf countries
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Kidney Diseases; Urologic Diseases; Connective Tissue Diseases; Glomerulonephritis; Lupus Erythematosus, Systemic; Nephritis; 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