Health Condition 1: N00-N99- Diseases of the genitourinary system
Conditions
Interventions
Intervention1: Early withdrawal of corticosteroid therapy: Adult (â?¥18 years) patients with nephrotic syndrome due to primary MCD/FSGS who achieved remission (SSNS) when treated for the first time wi
Sponsors
Funding applied for
Eligibility
Inclusion criteria
Inclusion criteria: Adult (>=18 years) patients with NS due to primary MCD/FSGS who achieved remission (SSNS) when treated for the first time with oral prednisolone 1mg/kg/day for at-least 4 weeks and a maximum duration of 16 weeks.
Exclusion criteria
Exclusion criteria: 1) eGFR (2) Nephrotic range proteinuria without nephrotic syndrome (3) Presence of other concomitant diseases on kidney biopsy (4) Secondary cause of MCD and FSGS (5) Concomitant systemic disease like diabetes, hepatitis B or C or HIV infection (6) Prior treatment with immunosuppression for NS (7) Prior treatment with immunosuppression for any other indication in the past 6 months (8) Patients who have concomitantly received other immunosuppressive drugs in addition to prednisolone for initial treatment of the NS
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome studied will be the incidence of relapse during or after withdrawing steroids during the follow up period of one year from the initiation of tapering of steroids.Timepoint: Time points at which patients will be assessed after randomization- every month for a period of 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcome studied will be the (1) mean number of relapses in the two groups (2) proportion of patients with frequent relapse (3) frequency of late steroid resistance in relapsing patients (4) renal survival free of 50% decline in eGFR or progression to ESKD (5) The incidence and type of adverse effects.Timepoint: 12 months follow up after randomization | — |
Countries
India
Contacts
Public ContactSoumita Bagchi
All India Institute of Medical Sciences
Outcome results
None listed