Overview

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

Status:
Terminated

Trial end date:
1999-12-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator:

Southwest Pediatric Nephrology Study Group

Treatments:

Atorvastatin
Atorvastatin Calcium

Criteria

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