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A study to evaluate the effect of standard dose vs monthly low dose of Rituximab in membranous nephropathy in reducing proteinuria and kidney function.

Comparative Efficacy and Safety of Low-Dose versus Standard-Dose Rituximab in Patients with Primary Membranous Nephropathy: An Open-Label Randomized Controlled Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/09/073172
Enrollment
40
Registered
2024-09-02
Start date
Unknown
Completion date
Unknown
Last updated
2024-09-16

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: Injection rituximab in low dose 100mg monthly: 100 mg In infusion monthly for 6 months till the response Control Intervention1: injection rituximab: 1 gm IV infusion , 2 weeks apart ( s

Sponsors

Nizams Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Biopsy proven Primary MN (with serum PL2AR positive) Anti - PL2AR levels more than fifteen and less than hundred and fifty No clinical and laboratory response to ACE/ARB therapy. KDIGO defined Moderate and Severe Primary MN CKD stages one two and three Nephrotic syndrome

Exclusion criteria

Exclusion criteria: Secondary cause of Membranous nephropathy Absence of Nephrotic syndrome KDIGO defined very severe PMN and life-threatening nephrotic complications Anti - PL2AR levels negative CKD STAGE four and five Pregnant females Concurrent use of any immunosuppression 3 months prior to study Lost to follow up Negative consent for the study Contraindications of immunosuppressive therapy (HIV, Hep B, Hep C)

Design outcomes

Primary

MeasureTime frame
Reduction in proteinuria complete and partial remission change in eGFR from baselineTimepoint: follow up till 1 year after end of intervention

Secondary

MeasureTime frame
to see safety and efficacy of rituximab change in the anti-PLA2R levels Timepoint: follow up over 1 year after end of intervention

Countries

India

Contacts

Public ContactSree Bhushan Raju

Nizams Institute of Medical Sciences

haardbarot@gmail.com9974704859

Outcome results

None listed

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