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A PROSPECTIVE OBSERVATIONAL STUDY COMPARING THREE DIFFERENT TREATMENT MODALITIES IN PRIMARY MEMBRANOUS NEPHROPATHY

A PROSPECTIVE OBSERVATIONAL STUDY COMPARING RITUXIMAB , TACROLIMUS AND MODIFIED PONTICELLI REGIMEN IN THREE DIFFERENT TREATMENT COHORTS OF PRIMARY MEMBRANOUS NEPHROPATHY

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2019/07/020113
Enrollment
30
Registered
2019-07-09
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: N042- Nephrotic syndrome with diffuse membranous glomerulonephritis

Interventions

None listed

Sponsors

IPGMER AND SSKM HOSPITAL KOLKATA
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

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.

Design outcomes

Primary

MeasureTime frame
a) Non inferiority of individual cohorts in inducing complete or partial remission in proteinuriaTimepoint: 1 YEAR

Secondary

MeasureTime frame
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. b) Estimated glomerular filtration rate (eGFR) at the completion of therapy Timepoint: 1 YEAR

Countries

India

Contacts

Public ContactDr ABHISHEK KUMAR

IPGMER AND SSKM HOSPITAL KOLKATA

lahiri.arpi@gmail.com9433254601

Outcome results

None listed

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