Health Condition 1: N042- Nephrotic syndrome with diffuse membranous glomerulonephritis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: •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).
Exclusion criteria
Exclusion criteria: •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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Remission rate at 6 months Timepoint: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Remission rate at 12 months Rituximab dose requirements. Time Interval to B cell recovery. Relapse rate. Changes in proteinuria and serum albumin. Side effect profileTimepoint: 12 months | — |
Countries
India
Contacts
AIIMS Rishikesh