Pilot Study of Atorvastatin in Children With Chronic Hyperlipidemia Secondary to Nephrotic Syndrome
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|ClinicalTrials.gov Identifier: NCT00004466|
Recruitment Status : Terminated (Very poor enrollment)
First Posted : October 19, 1999
Last Update Posted : September 15, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Nephrotic Syndrome Hyperlipidemia||Drug: Atorvastatin Drug: Placebo||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Actual Study Start Date :||October 1998|
|Actual Primary Completion Date :||December 1999|
|Actual Study Completion Date :||December 1999|
|Experimental: Atorvastatin||Drug: Atorvastatin|
|Placebo Comparator: Placebo||Drug: Placebo|
- Change in plasma lipid levels [ Time Frame: One year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004466
|United States, Texas|
|Medical City Dallas Hospital|
|Dallas, Texas, United States, 75230|
|Study Chair:||Ronald Hogg||Southwest Pediatric Nephrology Study Group|