A clinical trial to study the effects of two drugs, Cyclophosphamide and Mycophenolate Mofetil in patients with kidney involvement in Systemic Lupus Erythematosus.
Phase 3
- Conditions
- Health Condition 1: null- Systemic lupus erythematosus-Lupus nephritis
- Registration Number
- CTRI/2013/12/004179
- Lead Sponsor
- Dr Manish Rathi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 100
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 <3.0 mg/dl.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method -decrease in the urine protein/creatinine ratio to less than 3 in subjects with baseline nephrotic range proteinuria <br/ ><br>-decrease in the urine protein/creatinine ratio by more than 50% in subjects with sub-nephrotic proteinuria (3 urine protein/creatinine ratio). <br/ ><br>-Stabilization of serum creatinine (i.e., a week 24 serum creatinine level ±25% of baseline) or improvement. <br/ ><br>Timepoint: 3 months and six months
- Secondary Outcome Measures
Name Time Method -Complete renal remission, defined as return to normal serum creatinine, proteinuria â?¤500mg/24hr and inactive urine sediment <br/ ><br>-Systemic disease activity (assessed by Safety of Exogenous Estrogens in Lupus Erythematosus National Assessment/Systemic Lupus Erythematosus Disease Activity Index) <br/ ><br>-Adverse events. <br/ ><br>Timepoint: 3 months and six months