A PROSPECTIVE OBSERVATIONAL STUDY COMPARING THREE DIFFERENT TREATMENT MODALITIES IN PRIMARY MEMBRANOUS NEPHROPATHY
- Conditions
- Health Condition 1: N042- Nephrotic syndrome with diffuse membranous glomerulonephritis
- Registration Number
- CTRI/2019/07/020113
- Lead Sponsor
- IPGMER AND SSKM HOSPITAL KOLKATA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1.Biopsy proven PMN of age group 18-70 years, fulfilling the criteria for immunosuppression therapy .
2.Fulfilling the criteria for immunosuppression therapy - Urinary protein excretion persistently exceeds 4 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 threatning 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 25 ml/min per 1.73m2 AND this change is not explained by superimposed complications.
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.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method a)Non inferiority of individual cohorts in inducing complete or partial remission in proteinuriaTimepoint: 1 YEAR
- Secondary Outcome Measures
Name Time Method a)Sensitivity of anti PLA2R Ab in predicting partial or complete remission in 3 arms at 6 /12/24/30 months of initiation of therapy. <br/ ><br> <br/ ><br>b) Estimated glomerular filtration rate (eGFR) at the completion of therapy <br/ ><br> <br/ ><br> <br/ ><br>Timepoint: 1 YEAR