|
Pilot Study of Atorvastatin in Children with Chronic Hyperlipidemia Secondary to Nephrotic Syndrome Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Pilot Study of Atorvastatin in Children with Chronic Hyperlipidemia Secondary to Nephrotic Syndrome conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Pilot Study of Atorvastatin in Children with Chronic Hyperlipidemia Secondary to Nephrotic Syndrome Clinical research trials and Pilot Study of Atorvastatin in Children with Chronic Hyperlipidemia Secondary to Nephrotic Syndrome healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Pilot Study of Atorvastatin in Children with Chronic Hyperlipidemia Secondary to Nephrotic Syndrome. Pilot Study of Atorvastatin in Children with Chronic Hyperlipidemia Secondary to Nephrotic Syndrome Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Pilot Study of Atorvastatin in Children with Chronic Hyperlipidemia Secondary to Nephrotic Syndrome clinical trial. Human subjects often receive the most effective healthcare possible for their Pilot Study of Atorvastatin in Children with Chronic Hyperlipidemia Secondary to Nephrotic Syndrome condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "P" Clinical Trials Conditions > Pilot Study of Atorvastatin in Children with Chronic Hyperlipidemia Secondary to Nephrotic Syndrome  Pilot Study of Atorvastatin in Children with Chronic Hyperlipidemia Secondary to Nephrotic Syndrome
Pilot Study of Atorvastatin in Children with Chronic Hyperlipidemia Secondary to Nephrotic Syndrome
For Condition: Hyperlipidemia,Nephrotic Syndrome
Status: Completed
Sponsor(s): National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) , Southwest Pediatric Nephrology Study Group
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control
Minimum Age/Maximum Age: 6 Years/17 Years
Genders: Both
Protocol Entry 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
Total Enrollment: 30
Location and Contact Information:
Overall Study Official:
RonaldHogg, Study Chair, Southwest Pediatric Nephrology Study Group
Additional Information:
Study ID Numbers: 199/13924; SPNSG-5R21DK53611,PD-981-183,SPNSG-97.024
Study Start Date: October 1998
Record last reviewed: June 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004466
Other Hyperlipidemia Studies:
1. Rosiglitazone in the Treatment of HIV-Associated Hyperlipidemia
2. Metabolism and Body Shape of Healthy Children and Children with Chronic Infections
3. Differential Metabolism of Dietary Fatty Acids
4. Antihyperlipidemic Effects of Oyster Mushrooms
5. Pilot Study of Atorvastatin in Children with Chronic Hyperlipidemia Secondary to Nephrotic Syndrome
Related Studies:
Other Hyperlipidemia Clinical Trials
Other Clinical Trials
Other Clinical Trials
Pilot Study of Atorvastatin in Children with Chronic Hyperlipidemia Secondary to Nephrotic Syndrome
|
|
|
|
|
|
|
|
