Single Dose Pravastatin Pharmacokinetics in Pediatric Peritoneal Dialysis Patients

Phase 1TerminatedNCT00571194

Arkansas Children's Hospital Research Institute7 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

End Stage Renal Disease

Interventions

pravastatinDRUG

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

Eligibility

Sex: ALLMin age: 12 MonthsMax age: 18 Years

Medical Language ↔ Plain English

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: 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 -

Locations (1)

Arkansas Children's Hospital

Little Rock, Arkansas, United States

Outcomes

Primary Outcomes

Pharmacokinetics

Time frame: 24 hours

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.