Pilot Study of Atorvastatin in Children With Chronic Hyperlipidemia Secondary to Nephrotic Syndrome
| Status: | Terminated |
|---|---|
| Conditions: | High Cholesterol, Nephrology |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Nephrology / Urology |
| Healthy: | No |
| Age Range: | 6 - 17 |
| Updated: | 9/16/2017 |
| Start Date: | October 1998 |
| End Date: | December 1999 |
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.
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.
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.
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.
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
Chronic hyperlipidemia with treatment-resistant nephrotic syndrome; Must have received at
least 2 months of therapy with steroids on a daily or alternate basis
Primary nephropathy described as minimal change nephrotic syndrome, mesangioproliferative
glomerulonephritis, IgM neuropathy, and focal segmental glomerulosclerosis
Glomerular filtration rate at least 30 mL/min
LDL cholesterol at least 160 mg/dL
--Prior/Concurrent Therapy--
No concurrent medications affecting or interacting with lipids or atorvastatin, with the
exception of angiotensin converting enzyme inhibitors at discretion of referring physician,
including: lipid-lowering medications, beta blockers, thiazides, fish oils, cyclosporine,
Cytoxan, azathioprine, chlorambucil, and erythromycin
Concurrent prednisone and other corticosteroids allowed on a continual basis at a dose of
no greater than 1 mg/kg every other day (maximum dose, no greater than 40 mg every other
day); Concurrent acute courses of steroids no greater than 1 week for other unrelated
conditions (e.g., asthma) also allowed
--Patient Characteristics--
Hepatic: ALT or AST less than 2 times normal
Renal: See Disease Characteristics; Creatine phosphokinase less than 3 times normal
Other: No history of familial hypercholesterolemia; No systemic disease such as systemic
lupus, Schoenlein-Henoch purpura, Hodgkin's disease, polyarteritis nodosum, sickle cell
disease, or HIV; Not pregnant; Effective contraception required of all adolescent patients
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