Health Condition 1: N042- Nephrotic syndrome with diffuse membranous glomerulonephritis
Conditions
Interventions
Intervention1: Nil: Nil
Sponsors
PGIMER, Chandigarh
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age more than or equal to 18 years 2. Biopsy proven cases of MN 3. Treatment na ve and relapsing cases of MN 4. Proteinuria or protein creatinine ratio (PCR) more than or equal to 3.5 g/24h despite supportive treatment for at least 6 months 5. Serum albumin less than 30 g/L 6. eGFR more than or equal to 40 ml/min/1.73m2 at enrolment 6. Earlier treatment with immunosuppression is warranted, as determined by the treating physician.
Exclusion criteria
Exclusion criteria: 1. Previously received immunosuppression in past 2. Patients with active infection 3. Secondary Membranous Nephropathy 4. Biopsy suggestive of co-existent diabetic nephropathy in diabetic patients 5. Patients with uncontrolled diabetes, liver failure, heart failure 6. Kidney transplant recipients 7. Pregnancy 8. Suspected or known allergy to any of the drugs used in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective measure is an endpoint comprising efficacy, defined as either complete remission (CR) or partial remission (PR).Timepoint: 3,6,12,18 MONTHS | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events: is Count of serious adverse events (SAE) or nonserious adverse events of special interests (NSAESI)Timepoint: 3,6,12,18 MONTHS;Immunological remission (anti-PLA2R positive participants)Timepoint: ;Quality of life (36-Item Short Form Survey Instrument Questionnaire: SF-36)Timepoint: | — |
Countries
India
Contacts
Public ContactArun Prabhahar
PGIMER
Outcome results
None listed