Effectiveness and safety of low dose Rituximab in primary membranous nephropathy
- Conditions
- Health Condition 1: N042- Nephrotic syndrome with diffuse membranous glomerulonephritis
- Registration Number
- CTRI/2020/12/029849
- Lead Sponsor
- il
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
•Patients aged 18 years and older.
•Patients with diagnosis of Membranous nephropathy proven with renal biopsy (light microscopy and immunofluorescence microscopy) who are not responsive to conservative therapy after 3 months24 or who develop complications related to nephrotic syndrom.11
•Newly diagnosed patients or previously treated patients of membranous nephropathy presenting with relapse.
•Estimated GFR >=30 mL/min/1.73 m2 (CKD-EPI formula).
•Patients with underlying disorder (e.g. Hepatitis B and C, HIV, Systemic Lupus Erythematosus, medications causing membranous nephropathy, malignancies).
•History of hypersensitivity or allergic reaction to rituximab.
•Patients with life threatening complications of nephrotic syndrome like pulmonary embolism.
•Patients with rapid deterioration of renal function, not explained otherwise.
•Active infection/sepsis.
•Pregnancy or breast feeding.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Remission rate at 6 months <br/ ><br>Timepoint: 6 months <br/ ><br>
- Secondary Outcome Measures
Name Time Method Remission rate at 12 months <br/ ><br>Rituximab dose requirements. <br/ ><br>Time Interval to B cell recovery. <br/ ><br>Relapse rate. <br/ ><br>Changes in proteinuria and serum albumin. <br/ ><br>Side effect profileTimepoint: 12 months