Pilot Study of Atorvastatin in Children With Chronic Hyperlipidemia Secondary to Nephrotic Syndrome
I. Determine the effect of atorvastatin on the plasma levels of lipids, Lp(a), and apoproteins for treating hyperlipidemia in children with nephrotic syndrome in whom proteinuria and hyperlipidemia persist after other appropriate measures to treat their primary disease have been exhausted.
II. Determine the safety and tolerability of atorvastatin in these patients.
III. Provide preliminary data for a future investigation into the potential effect that lowering cholesterol levels may have on the rate of progression of renal insufficiency in such patients.
|Nephrotic Syndrome Hyperlipidemia||Drug: Atorvastatin Drug: Placebo||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
- Change in plasma lipid levels [ Time Frame: One year ]
|Actual Study Start Date:||October 1998|
|Study Completion Date:||December 1999|
|Primary Completion Date:||December 1999 (Final data collection date for primary outcome measure)|
|Experimental: Atorvastatin||Drug: Atorvastatin|
|Placebo Comparator: Placebo||Drug: Placebo|
This is a randomized, double blind, placebo controlled, multicenter study.
After 3 months of low cholesterol diet, patients are randomized to receive atorvastatin tablets daily (arm I) or placebo tablets daily (arm II) for 3 months. Arm I patients receive increasing doses of atorvastatin every 4 weeks until individual maximum tolerated doses (MTDs) are determined.
After 3 months of treatment, all patients are given atorvastatin in a 6-9 month open label extended evaluation. Arm I patients receive atorvastatin for an additional 6 months and arm II patients receive atorvastatin for 9 months with increasing doses of atorvastatin every 4 weeks for the first 3 months until MTDs are determined.
Patients are followed every 6-8 weeks for one year.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004466
|United States, Texas|
|Medical City Dallas Hospital|
|Dallas, Texas, United States, 75230|
|Study Chair:||Ronald Hogg||Southwest Pediatric Nephrology Study Group|