Health Condition 1: M321- Systemic lupus erythematosus withorgan or system involvement
Conditions
Interventions
Intervention1: Nil: Nil
Intervention2: Nil: Nil
Intervention3: Nil: Nil
Sponsors
Manipal Academy of Higher Education (MAHE), Manipal.
Eligibility
Inclusion criteria
Inclusion criteria: 30 newly diagnosed LN patients with renal biopsy-proven Class II, IV, or combination class with Class V lesions on renal histology, willing to provide informed consent to participate in the study. 15 newly diagnosed SLE patients without renal involvement as Disease Controls (DC). Absence of renal involvement is defined as, i. Urine RBCs: lesser than 2/ HPF ii. Random UpCr: lesser than 0.3mg/mg or 24hr-urine protein lesser than 300mg/ day iii. Serum creatinine: lesser than 1.l mg/dL SLE patients on a corticosteroid dose equivalent or less than 0.2mg/kg/day of prednisolone in the last one month. Patients previously treated with immunosuppressants such as mycophenolate mofetil (MMF) or cyclophosphamide may be included only if a minimum of: 3 months have passed since the last dose of MME, and 12 months since the last dose of cyclophosphamide, and the patient demonstrates clinical stability with no recent flare, to ensure immune reconstitution and minimise confounding of urinary immune cell profiles.
Exclusion criteria
Exclusion criteria: 1. Current/ recent infection in the last two weeks before enrolment. 2. Active Malignancy, blood dyscrasias, or current use of chemotherapeutic medications. 3. Patients with co-existing autoimmune diseases and mixed connective tissue diseases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Characterise the inflammatory cell lymphocyte subset distribution in the urine by flow cytometry.Timepoint: 36 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in the Extended Panel Urinary Lymphocyte Subsets (EPULS) from the time of recruitment (with high disease activity) and at each follow-up interval (0 months, 3 months, 6 months, and 12 months). Change in the EPULS profile over time with the class of immunosuppressive drug used for the management of LN.Timepoint: 36 months | — |
Countries
India
Contacts
Public ContactDharshan Rangaswamy
Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal.
Outcome results
None listed