Single Dose Pravastatin Pharmacokinetics in Pediatric Peritoneal Dialysis Patients

Stopped early · Phase 1

Conditions studied: End Stage Renal Disease

In brief

Many children with end stage renal disease develop hyperlipidemia. HMG-CoA (3-hydroxy-3-methylglutaryl-coenzyme A) 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.

Key facts

Study ID

NCT00571194

Run by

Arkansas Children's Hospital Research Institute

People needed

7

Starts

2007-09-01

Expected to finish

2009-05-01

Last updated by the study team

2017-03-15

Who can join

Age: 1 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

• Arkansas Children's Hospital — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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