Clinical trial NCT04971590: Study to Assess Demographic, Pharmacologic, Biomarker, Clinical Features and Quality of Life (QoL) of Participants With Lupus Nephritis
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Systemic Lupus Erythematosus
Keywords: LUNELORD
Systemic lupus erythematosus
Lupus nephritis
Organ damage
Gulf countries
Real-world
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2021-07-21
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants with demographic characteristics
timeFrame: Up to 1 year
measure: Number of participants with clinical manifestations of Lupus Nephritis
timeFrame: Up to 1 year
measure: Number of participants with comorbidities
timeFrame: Up to 1 year
measure: Severity of Lupus Nephritis in participants
timeFrame: Up to 1 year
measure: Number of participants with treatments for lupus nephritis
timeFrame: Up to 1 year
measure: 36-Item Short Form Health Survey (SF-36) total score
timeFrame: Up to 1 year
Secondary outcomes:
measure: Number of participants with refractory Lupus Nephritis
timeFrame: Up to 1 year
measure: Change from Baseline in anti-nuclear antibody
timeFrame: Baseline and up to 1 year
measure: Change from Baseline in antibody to double-stranded deoxyribonucleic acid test (anti-dsDNA antibody)
timeFrame: Baseline and up to 1 year
measure: Change from Baseline in complement (C3 and C4) levels
timeFrame: Baseline and up to 1 year
measure: Number of participants with renal remission
timeFrame: Up to 1 year
measure: Changes in the SF-36 physical and mental components score and the total scores at one year (Scores on a scale)
timeFrame: Baseline and 1 year
measure: Number of participants with healthcare resource utilization (HCRU)
timeFrame: Up to 1 year
measure: Direct medical costs associated with lupus nephritis management
timeFrame: Up to 1 year
measure: Number of participants with difference in treatment patterns
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Dubai
country: United Arab Emirates
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: