Single Dose Pravastatin Pharmacokinetics in Pediatric Peritoneal Dialysis Patients

• Status: Terminated
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Arkansas Children's Hospital Research Institute
• Treatments: Pravastatin

Criteria

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: Aspartate aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine phosphokinase(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 -