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

Recruiting

• Conditions: Systemic Lupus Erythematosus

• Registration Number: NCT04971590
• Lead Sponsor: GlaxoSmithKline

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-12
• Study First Submitted QC: 2021-07-12
• Study First Posted: 2021-07-21
• Study Start: 2021-09-14
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-22
• Last Update Posted: 2024-10-24
• Primary Completion: 2024-10-31
• Study Completion: 2024-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Number of participants with renal remission	Up to 1 year
Number of participants with refractory Lupus Nephritis	Up to 1 year
Direct medical costs associated with lupus nephritis management	Up to 1 year
Change from Baseline in anti-nuclear antibody	Baseline and up to 1 year
Number of participants with healthcare resource utilization (HCRU)	Up to 1 year
Change from Baseline in complement (C3 and C4) levels	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
Changes in the SF-36 physical and mental components score and the total scores at one year (Scores on a scale)	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 difference in treatment patterns	Up to 1 year

Trial Locations

Locations (1)

GSK Investigational Site; 🇦🇪 Dubai, United Arab Emirates