Effect of Lipid lowering Drug vAtorvastatin in Steroid resistance Nephrotic syndrome
- Conditions
- Health Condition 1: null- Steroid Resistant Nephrotic Syndrome with hyperlipidemia
- Registration Number
- CTRI/2012/07/002761
- Lead Sponsor
- ICMR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 50
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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. <br/ ><br>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. <br/ ><br>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 Outcome Measures
Name Time Method 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. <br/ ><br>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. <br/ ><br>Timepoint: 12 months