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Antibody targeted therapy in Membranous Nephropathy

Randomised Controlled Trial of aPLA2R-targeted therapy versus Standard Treatment in PLA2R related Membranous Nephropathy

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/05/008648
Enrollment
60
Registered
2017-05-25
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: null- Primary Membranous Nephropathy

Interventions

Intervention1: Anti-PLA2R Targeted therapy: Patients will be treated with cyclical cyclophosphamide and steroid therapy (Intravenous methylprednisolone 1 g/d for 3 consecutive days followed by oral

Sponsors

Postgraduate Institute of Medical Education and Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Biopsy-proven PMN, have a urinary protein excretion of >3.5 g/d or a urinary protein-to-creatinine ratio >3500 mg/g, and have a serum albumin of <=3.0 g/L, despite maximal tolerated dose of NIAT (angiotensinâ??converting enzyme inhibitors and/or angiotensin 2 receptor blockers, diuretics, and statin) for 6 months or those with complications of nephrotic syndrome viz; vascular thrombosis, respiratory tract infections requiring hospitalization or severe anasarca despite maximal tolerable dose of diuretics

Exclusion criteria

Exclusion criteria: Patients with secondary MN, estimated glomerular filtration rate < 45 ml/min 1.73 m2, pregnancy, breastfeeding, immunosuppressive treatment in the 3 preceding months, hepatitis B surface antigen /anti-HCV positive and other active infectious disease will be excluded.

Design outcomes

Primary

MeasureTime frame
Remission of Nephrotic Syndrome (both Complete and Partial)Timepoint: 6, 12 and 18 months

Secondary

MeasureTime frame
Adverse events, anti-PLA2R levels and decline in estimated GFR.Timepoint: 6, 12 and 18 months

Countries

India

Contacts

Public ContactRaja Ramachandran

PGIMER

drraja_1980@yahoo.co.in9216958874

Outcome results

None listed

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