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Single Dose Pravastatin Pharmacokinetics in Pediatric Peritoneal Dialysis Patients

This study has been completed.
Information provided by:
Arkansas Children's Hospital Research Institute Identifier:
First received: December 10, 2007
Last updated: August 31, 2009
Last verified: August 2009
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.

Condition Intervention
Pediatrics Patients on Dialysis
Drug: pravastatin

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
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

Resource links provided by NLM:

Further study details as provided by Arkansas Children's Hospital Research Institute:

Primary Outcome Measures:
  • pharmacokinetics [ Time Frame: 24 hours ]

Estimated Enrollment: 7
Study Start Date: September 2007
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Study drug given and have levels done to measure pharmacokinetics
Drug: pravastatin
single dose


Ages Eligible for Study:   12 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   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.

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 -
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Please refer to this study by its identifier: NCT00571194

United States, Arkansas
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
Sponsors and Collaborators
Arkansas Children's Hospital Research Institute
Principal Investigator: Eileen N Ellis, MD Arkansas Children's Hospital Research Institute
  More Information

Responsible Party: Eileen Ellis, MD, Arkansas Children's Hospital Identifier: NCT00571194     History of Changes
Other Study ID Numbers: 75611 
Study First Received: December 10, 2007
Last Updated: August 31, 2009

Keywords provided by Arkansas Children's Hospital Research Institute:
pravastatin, peritoneal dialysis, pediatric patients

Additional relevant MeSH terms:
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors processed this record on February 24, 2017