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

NCT00004466 | Terminated Phase 2 FDA Drug

• 4 other identifiers: 199/13924R21DK053611PD-981-183SPNSG-97.024
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nephrotic Syndrome; Hyperlipidemia

Keywords

cardiovascular and respiratory diseases; hyperlipidemia; nephrotic syndrome; rare disease; renal and genitourinary disorders

Outcome Measures

Primary Outcomes (1)

• Change in plasma lipid levels

  One year

Study Arms (2)

Atorvastatin

EXPERIMENTAL

Drug: Atorvastatin

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Atorvastatin DRUG

Atorvastatin

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): lead
• Southwest Pediatric Nephrology Study Group: collaborator

Study Sites (1)

Medical City Dallas Hospital

Dallas, Texas, 75230, United States

Location

MeSH Terms

Conditions

Nephrotic Syndrome; Hyperlipidemias; Respiratory Tract Diseases; Rare Diseases; Urogenital Diseases

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Nephrosis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Male Urogenital Diseases; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Ronald Hogg

  Southwest Pediatric Nephrology Study Group

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 1999
• First Posted: October 19, 1999
• Study Start: October 1, 1998
• Primary Completion: December 1, 1999
• Study Completion: December 1, 1999
• Last Updated: September 15, 2017

Record last verified: 2017-09

Locations

US (1)