Last updated: 12/02/2025 17:50:09
Study to assess demographic, pharmacologic, biomarker, clinical features and quality of life (QoL) of participants with Lupus Nephritis
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
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
Trial description: 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).
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Number of participants with demographic characteristics
Timeframe: Up to 1 year
Number of participants with clinical manifestations of Lupus Nephritis
Timeframe: Up to 1 year
Number of participants with comorbidities
Timeframe: Up to 1 year
Severity of Lupus Nephritis in participants
Timeframe: Up to 1 year
Number of participants with treatments for lupus nephritis
Timeframe: Up to 1 year
36-Item Short Form Health Survey (SF-36) total score
Timeframe: Up to 1 year
Secondary outcomes:
Number of participants with refractory Lupus Nephritis
Timeframe: Up to 1 year
Change from Baseline in anti-nuclear antibody
Timeframe: Baseline and up to 1 year
Change from Baseline in antibody to double-stranded deoxyribonucleic acid test (anti-dsDNA antibody)
Timeframe: Baseline and up to 1 year
Change from Baseline in complement (C3 and C4) levels
Timeframe: Baseline and up to 1 year
Number of participants with renal remission
Timeframe: 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)
Timeframe: Baseline and 1 year
Number of participants with healthcare resource utilization (HCRU)
Timeframe: Up to 1 year
Direct medical costs associated with lupus nephritis management
Timeframe: Up to 1 year
Number of participants with difference in treatment patterns
Timeframe: Up to 1 year
Interventions:
Enrollment:
193
Primary completion date:
2024-31-10
Observational study model:
Cohort
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Systemic Lupus Erythematosus
Product
rituximab
Collaborators
Not applicable
Study date(s)
September 2021 to October 2024
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- More than or equal to 18 years of age
- Clinician diagnosed LN participants.
- 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.
Inclusion and exclusion 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.
Trial location(s)
Showing 1 - 6 of 7 Results
Study documents
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
No study documents available
Recruitment status
Study complete
Actual primary completion date
2024-31-10
Actual study completion date
2024-31-10
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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