Health Condition 1: N042- Nephrotic syndrome with diffuse membranous glomerulonephritis
Conditions
Interventions
Intervention1: Low-Dose Cyclical Cyclophosphamide and Steroid: Oral prednisolone 0.5 mg/kg per day in the first, third, and fifth month and oral Cyclophosphamide at 1-1.5 mg/kg per day in the second,
Sponsors
Postgraduate Institute of Medical Education and Research
Eligibility
Inclusion criteria
Inclusion criteria: 1. Biopsy-proven primary membranous nephropathy 2. Nephrotic syndrome despite non-immunosuppressive anti-proteinuric therapy for 3 months or membranous nephropathy with deep vein thrombosis (DVT) or requiring hospitalization for complications of nephrotic syndrome 3. Patients showing severe or disabling symptoms related to nephrotic syndrome, or severe hypoalbuminemia ( <2 g/dL) that can be included before the completion of 3-month observation period at the discretion of the investigator independent of the proteinuria value.
Exclusion criteria
Exclusion criteria: 1)Patients with eGFR 2)Prior, active infection including hepatitis B/C and HIV infection, 3)Positive for anti-nuclear factor, 4)Any suggestion of malignancy on ultrasonography, 5)Hypocomplementemia, 6)Presence of tubular atrophy and 7)Pre-existing DM, 8)Abnormal liver function tests and secondary MN 9)Any immunosuppressive therapy in the last 12 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Remission ratesTimepoint: 12 and 24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Adverse events in both the groups. 2. Serum levels of anti-phospholipase A2 receptor antibodies (anti-PLA2R), before of treatment & at 3, 6, 12 months & at relapse, in both treatment arms. 3.CR & PRTimepoint: 12 & 24 months | — |
Countries
India
Contacts
Public ContactRaja Ramachandran
PGIMER
Outcome results
None listed