Health Condition 1: M321- Systemic lupus erythematosus withorgan or system involvement
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Diagnosed as SLE by SLICC/ACR criteria and biopsy-proven lupus nephritis (Class III/IV/V combinations). Has completed induction immunosuppressive regimen for at least 6 months and is on maintenance therapy for LN. Able to provide informed consent.
Exclusion criteria
Exclusion criteria: Patients with overlap syndromes, post-kidney transplant ESKD on dialysis, and patients not on immunosuppressive drugs for LN. Severe psychiatric illness interfering with questionnaire completion. Recent hospital admission, serious infection, cancer, or an acute illness in the past 4 weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome of this study is the Mean overall Quality of Life (QoL) score as measured by the LupusQoL and EQ-5D-5L instruments in patients with lupus nephritis who are on maintenance immunosuppression.Timepoint: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Domain-specific QoL scores from LupusQoL. Comparison of QoL scores between different LN classes (e.g., Class III, IV, V combinations) and disease remission states. Impact of steroid burden (cumulative dose and current dose) on QoL scores and proportion of patients reporting moderate to severe impairment in specific EQ-5D-5L dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and obtaining mean health utility score derived from EQ 5D-5L responses using the Indian value set.Timepoint: 6 months | — |
Countries
India
Contacts
Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal.