NCT00004466

Pilot Study of Atorvastatin in Children With Chronic Hyperlipidemia Secondary to Nephrotic Syndrome

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · NIH
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

OBJECTIVES: 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.

Detailed description

PROTOCOL OUTLINE: 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.

Conditions

• Nephrotic Syndrome
• Hyperlipidemia

Interventions

Type	Name	Description
DRUG	Atorvastatin
DRUG	Placebo

Timeline

• Start date: 1998-10-01
• Primary completion: 1999-12-01
• Completion: 1999-12-01
• First posted: 1999-10-19
• Last updated: 2017-09-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study