Single Dose Pravastatin Pharmacokinetics in Pediatric Peritoneal Dialysis Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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This is a single-dose pilot study to evaluate the pharmacokinetic profile of pravastatin in 7 pediatric and adolescent subjects ranging from 12 months to 16 years of age who are on dialysis. The study group will be comprised of healthy children receiving continuous cycling peritoneal dialysis (CCPD). Pravastatin dosing will be 10 mg in all subjects. Blood, urine, and dialysate samples will be obtained over a 24-hour period post-dose for measurement of pravastatin concentrations. Safety evaluations will include adverse events (AEs), physical examination, vital signs, and clinical laboratory evaluations.

Official Title
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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

Conditions
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End Stage Renal Disease

Intervention / Treatment
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* Drug: pravastatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. - Exclusion Criteria: 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 -

Ages Eligible for Study
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Minimum Age: 12 Months
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: peritoneal dialysis (CCPD)<br>PK profile of pravastatin | Drug: pravastatin<br>* A single 10 mg dose of pravastatin will be administered 3 mL blood samples for pravastatin Pharmacokinetic evaluations will be collected at 0.5, 1, 2, 3, 4, 6, and 8 hours. 5 mL blood samples for pravastatin PK and laboratory evaluations will be drawn at pre-dose and 24 hours. Vital Signs and Physical Exams will also be done throughout the study<br>* Other names: Pravachol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics |  | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pravastatin, peritoneal dialysis, pediatric patients