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

Systemic Lupus Erythematosus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04971590
• Other study ID #: 216989
• Status: Recruiting
• Start date: September 14, 2021
• Est. completion date: January 30, 2023

Study information

• Verified date: April 2022
• Source: GlaxoSmithKline
• Contact: US GSK Clinical Trials Call Center
• Phone: 877-379-3718
• Email: GSKClinicalSupportHD[@]gsk.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: January 30, 2023
• Est. primary completion date: January 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Lupus Nephritis
• Nephritis
• Systemic Lupus Erythematosus

Intervention

Other:
• Participant completed survey
Participants will be required to complete the participant survey.
• Medical chart review
Data will be collected from medical charts of participants.

Locations

Country	Name	City	State
United Arab Emirates	GSK Investigational Site	Dubai

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United Arab Emirates, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with demographic characteristics		Up to 1 year
Primary	Number of participants with clinical manifestations of Lupus Nephritis		Up to 1 year
Primary	Number of participants with comorbidities		Up to 1 year
Primary	Severity of Lupus Nephritis in participants		Up to 1 year
Primary	Number of participants with treatments for lupus nephritis		Up to 1 year
Primary	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	Number of participants with refractory Lupus Nephritis		Up to 1 year
Secondary	Change from Baseline in anti-nuclear antibody		Baseline and up to 1 year
Secondary	Change from Baseline in antibody to double-stranded deoxyribonucleic acid test (anti-dsDNA antibody)		Baseline and up to 1 year
Secondary	Change from Baseline in complement (C3 and C4) levels		Baseline and up to 1 year
Secondary	Number of participants with renal remission		Up to 1 year
Secondary	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
Secondary	Number of participants with healthcare resource utilization (HCRU)		Up to 1 year
Secondary	Direct medical costs associated with lupus nephritis management		Up to 1 year
Secondary	Number of participants with difference in treatment patterns		Up to 1 year