Health Condition 1: null- Steroid Resistant Nephrotic Syndrome with hyperlipidemia
Conditions
Interventions
Intervention1: Atorvastatin: Atorvastain 10mg per day for one year per oral
Control Intervention1: Placebo: Placebo in same dose Per oral
Sponsors
ICMR
Eligibility
Inclusion criteria
Inclusion criteria: 1)Patient with LDL Cholesterol Between 130-300mg/dl on 2 occassions at least one week apart. 2)Patient with stable dose of immunosuppressive medication (Prednisolone and Calcineurin inhibitors)for aperiod of 3 months.
Exclusion criteria
Exclusion criteria: 1) History of jaundice in last 6 months: AST/ALT levels more than twice normal of upper limit of the laboratory reference value. 2) CPK levels more than 3 times normal. 3) Children on lipid lowering agents such asHMG CoA reductase inhibitors in the past 3 months. 4)Family History of premature CVD 5)Patients with secondary nephrotic syndrome(SLE,IgAN,MPGN,MGN Alports disease) 6)Patients on pulse corticosteroids or cyclophosphamide in last 6 months. 7)Patients with stage 2 hypertension. 8)GFR30ml/min/m2 or below 9)Children residing beyond 200km from delhi.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare serum level of LDL cholesterol and triglycerides in children aged 5-18 years with steroid resistant nephrotic syndrome and hyperlipidemia with LDL Level 130mg/dl treated with atorvastatin 10mg/day and placebo at 6 months in double blind randomized control manner. To compare rate of progression of CIMT in children aged 5-18 yrs with SRNS and hyperlipidemia with LDL Level 130mg/dl treated with atorvastatin 10mg/day and placebo at 12 months in double blind randomized control mannerTimepoint: To compare serum level of LDL and triglycerides in children aged 5-18 years with SRNS and hyperlipidemia with LDL Level 130mg/dl treated with atorvastatin 10mg/day and placebo at 6 months in double blind randomized control manner. To compare rate of progression of CIMT in children aged 5-18 yrs with SRNS and hyperlipidemia with LDL Level 130mg/dl treated with atorvastatin 10mg/day and placebo at 12 months in double blind randomized control manner.CIMT at year and LDL at 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare serum levels of VLDL HDL cholesterol and triglycerides and brachial artery FMD in children aged 5-18 yrs with SRNS and hyperlipidemia treated with atorvastatin 10mg/day and placebo at 6 months,and at 12 months. To compare the side effects and tolerability of atorvastatin and placebo given to children aged 5-18 yrs with SRNS and hyperlipidemia treated with atorvastatin 10mg/day and placebo at 12 months. Timepoint: 12 months | — |
Countries
India
Contacts
Public ContactDr Pankaj Hari
AIIMS New Delhi
Outcome results
None listed