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

This study has been completed.
Sponsor:
Collaborator:
Southwest Pediatric Nephrology Study Group
Information provided by:
Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:
NCT00004466
First received: October 18, 1999
Last updated: June 23, 2005
Last verified: June 2000
  Purpose

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.


Condition Intervention
Nephrotic Syndrome
Hyperlipidemia
Drug: atorvastatin

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment: 30
Study Start Date: October 1998
Estimated Study Completion Date: December 1999
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.

  Eligibility

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004466

Sponsors and Collaborators
Southwest Pediatric Nephrology Study Group
Investigators
Study Chair: Ronald Hogg Southwest Pediatric Nephrology Study Group
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00004466     History of Changes
Other Study ID Numbers: 199/13924, SPNSG-5R21DK53611, PD-981-183, SPNSG-97.024
Study First Received: October 18, 1999
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

Keywords provided by Office of Rare Diseases (ORD):
cardiovascular and respiratory diseases
hyperlipidemia
nephrotic syndrome
rare disease
renal and genitourinary disorders

Additional relevant MeSH terms:
Hyperlipidemias
Syndrome
Nephrotic Syndrome
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Disease
Pathologic Processes
Nephrosis
Kidney Diseases
Urologic Diseases
Atorvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on October 19, 2014