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Effectiveness and safety of low dose Rituximab in primary membranous nephropathy

Efficacy and Safety of B Cell Targeted Low Dose Rituximab in Primary Membranous Nephropathy: Prospective Single Arm Interventional Study (A Pilot Study)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/12/029849
Enrollment
10
Registered
2020-12-16
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N042- Nephrotic syndrome with diffuse membranous glomerulonephritis

Interventions

Intervention1: B cell targeted Low dose rituximab: B cell targeted low dose rituximab in patients with primary membranous nephropathy who are not responsive to conservative therapy after 3 months or w

Sponsors

Nil
Lead Sponsor

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

MeasureTime frame
Remission rate at 6 months Timepoint: 6 months

Secondary

MeasureTime 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

Public ContactDr Amninder Kaur

AIIMS Rishikesh

minakshi.dhar@rediffmail.com7060002778

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026