Health Condition 1: N049- Nephrotic syndrome with unspecified morphologic changes
Conditions
Interventions
Intervention1: Oral Mycophenolate Mofetil: Oral Mycophenolate mofetil (Dose: 750-1000 mg/ m2) in two divided dosages. Duration: at-least 12 months.
Control Intervention1: Oral Cyclophosphamide: Oral C
Sponsors
GURDEEP SINGH DHOORIA
Dayanand Medical College and Hospital Ludhiana Punjab
Eligibility
Inclusion criteria
Inclusion criteria: Children with Frequent Relapsing Steroid Dependent Nephrotic Syndrome
Exclusion criteria
Exclusion criteria: 1. Congenital Nephrotic Syndrome 2. Steroid Resistant Nephrotic Syndrome 3. Patients with an estimated glomerular filtration rate ( per 1.73 m2 4. Known secondary causes including systemic lupus, Henoch Schonlein purpura, IgA nephropathy or chronic infection (tuberculosis, HIV, hepatitis B or C. 5. Prior therapy with MMF, cyclosporine, tacrolimus, or cyclophosphamide in the past 6 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of children off steroids for atleast 6 months after starting treatment with MMF OR children off steroids for atleast 6 months after 8-12 weeks course of oral cyclophosphamide will be defined as RespondersTimepoint: At baseline, 3 months, 6 months, 9 months and 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Frequency of side effects in each groupTimepoint: In Numbers and Proportion till end of 12 months;Number of relapses in 12 months of therapyTimepoint: In numbers at the end of 12 months period;Proportion of Frequent relapsers (more than or equal to 3) in 12 months of MMF therapyTimepoint: Percentage till end of 12 months;Proportion of Infrequent Relapsers after 12 months of therapyTimepoint: Percentage at 12 months period;Time to first relapse. Timepoint: In months - till end of 12 months period | — |
Countries
India
Contacts
Public ContactDr Gurdeep Singh Dhooria
Dayanand Medical College and Hospital, LudhianaAND HOSPITAL, LUDHIANA, PUNJAB, INDIA
Outcome results
None listed