Health Condition 1: null- Systemic lupus erythematosus-Lupus nephritis
Conditions
Interventions
Intervention1: Cyclophosphamide: Six fortnightly intravenous pulses at a fixed dose of 500 mg i.e six doses over a period of three months to be followed by Azathioprine 2mg/kg/day as maintenance thera
Sponsors
Dr Manish Rathi
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients aged 12 to 65 year with diagnosis of Systemic Lupus Erythematosus by American College of Rheumatology criteria (ACR) 2. Kidney biopsy diagnosis of Lupus nephritis class III, IV, V, III+V, IV+V 3.Serum creatinine
Exclusion criteria
Exclusion criteria: 1. Severe proliferative lupus nephritis on histology (eg. Crescentic glomerulonephritis) 2. Ongoing infection 3. Pregnant females 4. Previously received immunosuppressive treatment 5. Patient not giving consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -decrease in the urine protein/creatinine ratio to less than 3 in subjects with baseline nephrotic range proteinuria -decrease in the urine protein/creatinine ratio by more than 50% in subjects with sub-nephrotic proteinuria (3 urine protein/creatinine ratio). -Stabilization of serum creatinine (i.e., a week 24 serum creatinine level ±25% of baseline) or improvement. Timepoint: 3 months and six months | — |
Secondary
| Measure | Time frame |
|---|---|
| - Complete renal remission, defined as return to normal serum creatinine, proteinuria â?¤500mg/24hr and inactive urine sediment - Systemic disease activity (assessed by Safety of Exogenous Estrogens in Lupus Erythematosus National Assessment/Systemic Lupus Erythematosus Disease Activity Index) - Adverse events. Timepoint: 3 months and six months | — |
Countries
India
Contacts
Public ContactDr Ajay Goyal
Post Graduate Institute of Medical Education and Research
Outcome results
None listed