N/A
N=193
Study to Assess Demographic, Pharmacologic, Biomarker, Clinical Features and Quality of Life (QoL) of Participants With Lupus Nephritis
Systemic Lupus Erythematosus
Bottom Line
View on ClinicalTrials.gov: NCT04971590 ↗Enrolled (actual)
193
Serious AEs
2.6%
Results posted
Jan 2026
Primary outcome: Primary: Number of Participants Categorized by Demographic Characteristics — 143; 50; 88; 3 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Participant completed survey (Other); Medical chart review (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Oct 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Categorized by Demographic Characteristics |
143; 50; 88; 3; 30; 58 | — |
| PRIMARY Number of Participants With Active Clinical Manifestations of Lupus Nephritis |
59; 23; 46; 13; 32; 17 | — |
| PRIMARY Number of Participants With Comorbidities |
134 | — |
| PRIMARY Number of Participants With Severe Lupus Nephritis |
60 | — |
| PRIMARY Number of Participants Categorized by Treatments for Lupus Nephritis |
152; 2; 185; 81; 19; 26 | — |
| PRIMARY Short Form Health Survey (SF-36) Health-related Quality of Life Domain Score |
67.6; 59.5; 64.1; 66.5; 67.9; 69.7 | — |
| SECONDARY Number of Participants With Refractory Lupus Nephritis |
33 | — |
| SECONDARY Number of Participants With Abnormal Findings for Serological Markers |
2; 0; 2; 3; 52; 55 | — |
| SECONDARY Number of Participants With Renal Remission That Were Associated With Clinical Factors, Biomarkers, and Treatments |
123 | — |
| SECONDARY Percent Change From Baseline in SF-36 Scores for Each Health Domain:Physical Functioning, Pain, Role Limitations Due to Physical Health, Role Limitations Due to Emotional Problem, Emotional Well-being, Social Functioning, Energy/Fatigue and General Health |
23.7; 29; 1.4; 0.9; 6.6; 13.4 | — |
| SECONDARY Number of Participants With Hospitalizations and Intensive Care Unit (ICU) Hospitalizations |
14; 1 | — |
| SECONDARY Direct Medical Costs Associated With Lupus Nephritis Management |
517; 141.6; 467.6 | — |
| SECONDARY Number of Participants With Treatment for Lupus Nephritis by Sector (Public or Private Sector) |
102; 48; 2; 0; 118; 67 | — |
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.
Data sourced from ClinicalTrials.gov (NCT04971590). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.