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| Sponsors and Collaborators: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Southwest Pediatric Nephrology Study Group |
|---|---|
| Information provided by: | Office of Rare Diseases (ORD) |
| ClinicalTrials.gov Identifier: | NCT00004466 |
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: | Treatment, Randomized, Double-Blind, Placebo Control |
| Estimated Enrollment: | 30 |
| Study Start Date: | October 1998 |
| Estimated Study Completion Date: | December 1999 |
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 |
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 More Information
| Study ID Numbers: | 199/13924, SPNSG-5R21DK53611, PD-981-183, SPNSG-97.024 |
| Study First Received: | October 18, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00004466 History of Changes |
| Health Authority: | United States: Federal Government |
|
cardiovascular and respiratory diseases hyperlipidemia nephrotic syndrome rare disease renal and genitourinary disorders |
|
Antimetabolites Hyperlipidemias Metabolic Diseases Antilipemic Agents Respiration Disorders Rare Diseases Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Nephrosis |
Urologic Diseases Neoplasm Metastasis Kidney Diseases Metabolic Disorder Dyslipidemias Atorvastatin Nephrotic Syndrome Lipid Metabolism Disorders |
|
Antimetabolites Hyperlipidemias Metabolic Diseases Disease Molecular Mechanisms of Pharmacological Action Antilipemic Agents Enzyme Inhibitors Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions |
Nephrosis Pathologic Processes Urologic Diseases Therapeutic Uses Syndrome Kidney Diseases Dyslipidemias Atorvastatin Nephrotic Syndrome Lipid Metabolism Disorders |
