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Effect of Lipid lowering Drug vAtorvastatin in Steroid resistance Nephrotic syndrome

Not Applicable
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
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

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
NameTimeMethod
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
NameTimeMethod
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
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