Health Condition 1: null- Idiopathic Membranous Nephropathy Health Condition 2: N042- Nephrotic syndrome with diffuse membranous glomerulonephritis
Conditions
Interventions
Intervention1: Treatment of Idiopathic Membranous Nephropathy with immunosuppressant.: Patients will be treated with i v rituximab or modified ponticelli regimen and response will be compared between
Month 2: oral cyclophosphamide (2.0 mg/kg/d) for 30 days
Month 3: Repeat Month 1
Month 4: Repeat Month 2
Month 5: Repeat Month 1
Month 6: Repeat Month 2 ].
Control Intervention2: Cyclical corticosteroid/alkylating-agent ( modified Ponticelli Regimen ), Rituximab.: Arm-II will receive injection rituximab 375 mg/m2 BSA once we
Month 6: Repeat Month 2 ].
Control Intervention4: Cyclical corticosteroid/alkylating-agent ( modified Ponticelli Regimen ), Rituximab.: Arm-II will receive injection rituximab 375 mg/m2 BSA once
Sponsors
IPGMER and SSKM hospital
Eligibility
Inclusion criteria
Inclusion criteria: INCLUSION CRITERIA 1. Biopsy proven IMN, fulfilling the criteria for initiation of immunosuppression. 2. Estimated glomerular filtration rate (by MDRD) >30 ml/min/1.73m2 BSA. 3. Persistent proteinuria >4g/24 hr or > 50% of the baseline value despite receiving maximum tolerable dose of antiproteinuric medication (ACEI/ARBs/Statins ) for last 6 months. 4. Severe disabling or life threatening symptoms related to the nephrotic syndrome. 5. Conditions necessary for the use of immunosuppressant. 6. No contraindication to any of the medication used in the study.
Exclusion criteria
Exclusion criteria: EXCLUSION CRITERIA 1. Patients with active infection. 2. Diabetes mellitus. 3. Hepatitis B/C or human immunodeficiency virus infection. 4. Liver function abnormalities. 5. Neoplasia. 6. Chronic Diarrhoea. 7. Pregnancy. 8. Patients not willing for contraception. 9. Membranous lupus nephritis. 10. Previous therapy with Prednisolone, MMF, CSA within 4 months and alkylating agents within 6 months. 11. More than one episode of serious infections (e.g. peritonitis, lower respiratory infection, cellulitis) in the past 12 months, current or previous therapy for tuberculosis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome will be the cumulative number of patients who will experience remission both partial and complete remission on the basis of urine protein analysis.Timepoint: Final outcome will be assessed at month 12. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcome a) Estimated glomerular filtration rate (eGFR) at the completion of therapy b) Change in Sr albumin level c) Change in lipid profile d) Time required for complete or partial remission e) Adverse effects (Myelosuppression, hematuria, impaired glucose tolerance (IGT)/diabetes mellitus, diarrhoea and impaired fasting lipid profile, infection). Timepoint: 15 months | — |
Countries
India
Contacts
Public ContactAbhinaba Debnath
IPGMER and SSKM hospital, Kolkata
Outcome results
None listed