Official Title: “A Single-Dose Pilot Study to Evaluate the Pharmacokinetics of Pravastatin Given as an Oral Dose in Pediatric and Adolescent Subjects 12 Months to 16 Years of Age Receiving Continuous Cycling Peritoneal Dialysis”

Many children with end stage renal disease develop hyperlipidemia.HMG-CoA reductase inhibitors, such as pravastatin, are typical treatments for hyperlipidemia. However, we do not know how pravastatin is metabolized in patients on dialysis. This study is designed to provide preliminary pharmacokinetic data for pravastatin in pediatric patients on peritoneal dialysis.

Study Type: Interventional

Study Design: Other, Open Label, Single Group Assignment, Pharmacokinetics Study

Intervention(s) in this Clinical Trial

• Drug: pravastatin
  • single dose

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Study drug given and have levels done to measure pharmacokinetics

Primary Measures

• pharmacokinetics
  • Time Frame: 24 hours
    Safety Issue?: No

Inclusion Criteria:

• 1. Patients from 12 months to 18 years of age.
• 2. Patients with end stage renal disease who receive continuous cycling peritoneal dialysis.
• 3. signed informed consent
• 4. Physical exam demonstrates no abnormalities that would make this study medically hazardous to the subject.
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Exclusion Criteria:

• 1. Any clinically significant unstable medical condition or chronic disease other than those associated with ESRD.
• 2. Any clinically significant illness within 10 days or receiving single-sdoe of study medication
• 3. History of rhabdomyolysis
• 4. Clinically significant liver disease or history of malabsorption or previous gastrointestinal surgery that could effect drug absorption or metabolism.
• 5. Clinical laboratory abnormalities: AST,ALT, CPK > 2.5 times upper limit of normal;
• hemoglobin < 8.5 g.dL.
• 6. Known hypersensitivity to pravastatin
• 7. Unwilling to have blood samples drawn
• 8. Has taken a HMG-CoA reductase inhibitor in the last week -

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 12 Months

Maximum Age for this Clinical Trial: 18 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Arkansas Children's Hospital Research Institute

Overall Clinical Trial Officials and Contacts

Eileen N Ellis, MD Principal Investigator Arkansas Children's Hospital Research Institute  

Overall Contact: Eileen N Ellis, MD 501-364-1847 elliseileenn@uams.edu

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00571194

Study ID Number: 75611

ClinicalTrials.gov Identifier: NCT00571194

Health Authority: United States: Institutional Review Board