Health Condition 1: N042- Nephrotic syndrome with diffuse membranous glomerulonephritis
Conditions
Interventions
Intervention1: rituximab drug: one arm consists of drug rituximab given at dose of 375 mg/m2 iv weekly for 4 doses only
Control Intervention1: tab tacrolimus: second arm consist of patient on tab tacr
Sponsors
IPGMER SSKM hospital
Eligibility
Inclusion criteria
Inclusion criteria: 1. Biopsy proven PMN of age group 18-70 years, 2. Fulfilling the criteria for initiation of immunosuppression- Urinary protein excretion persistently exceeds4 g/d AND remains at over 50% of the baseline value, AND does not show progressive decline, during antihypertensive and antiproteinuric therapy during an observation period of at least 6 months or Severe disabling or life threatening symptoms related to the nephrotic syndrome. 3. SCr has risen by 30% or more within 6 to 12 months from the time of diagnosis but the eGFR is not less than 25â??30 ml/min per 1.73m2 AND this change is not explained by superimposed complications.
Exclusion criteria
Exclusion criteria: 1. Patients with active infection. 2. Diabetes mellitus. 3. Hepatitis B/C or human immunodeficiency virus infection. 4. Superimposed any other liver disease. 5. Neoplasia. 6. Chronic Diarrhoea. 7. Pregnancy. 8. Patients not willing for contraception. 9. Previous therapy with Prednisolone, MMF,CSA within 4 months and alkylating agents within 6 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of patients who will experience remission both partial and complete remission on the basis of urine protein analysis.Timepoint: The duration of follow-up will be at least 6 month | — |
Secondary
| Measure | Time frame |
|---|---|
| a) Estimated glomerular filtration rate (eGFR) at the completion of therapy b) Change in 24 hour urinary protein c) Change in Sr albumin level d) Time required for complete or partial remission e) Adverse effects (leukopenia, impaired glucose tolerance (IGT)/diabetes mellitus, diarrhoea, new onset hypertension and impaired fasting lipid profile, infection). Timepoint: at least 6 months | — |
Countries
India
Contacts
Public ContactAneesh Nanda
IPGMER, SSKM hospital, kolkata
Outcome results
None listed