Health Condition 1: N042- Nephrotic syndrome with diffuse membranous glomerulonephritis
Conditions
Interventions
Intervention1: Nil: Nil
Control Intervention1: Nil: Nil
Sponsors
NONE
Eligibility
Inclusion criteria
Inclusion criteria: Those with biopsy proven primary membranous nephropathy
Exclusion criteria
Exclusion criteria: 1. Pregnancy 2. Presence of active infection 3. Evidence of secondary cause of MN (e.g. hepatitis B, SLE, drugs, malignancy) 4. Estimated GFR (eGFR)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete/partial remission at 6 months Complete remission (CR) : Proteinuria lesser than 0.3g/day or UPCR lesser than 0.3 mg/mg, with normalization of serum albumin (more than or equal to 3.5g/dL) Partial remission : Reduction of 24 hour urine protein (or UPCR) to lesser than 50% of baseline to lesser than 3.5g/day (or UPCR lesser than 3.5mg/mg), but greater than 0.3g/day (or UPCR greater than 0.3mg/mg) Timepoint: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Rate of eGFR decline 2. Anti-PLA2R levels at 6 and 12 months post-therapy 3. Frequency and time to relapse of nephrotic state 4. Serious adverse events: Any adverse event that results in death, is life-threatening, requires hospitalization or prolongs hospital stay (serious infections, myelotoxicity, malignancy, thromboembolic events) 5. Non-serious adverse events Timepoint: Six and twelve months | — |
Countries
India
Contacts
Public ContactIndu R Rao
KMC Manipal
Outcome results
None listed