NCT00571194

Single Dose Pravastatin Pharmacokinetics in Pediatric Peritoneal Dialysis Patients

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Arkansas Children's Hospital Research Institute · Academic / Other
• Sex: All
• Age: 12 Months – 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• End Stage Renal Disease

Interventions

Type	Name	Description
DRUG	pravastatin	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

Timeline

• Start date: 2007-09-01
• Primary completion: 2009-05-01
• Completion: 2009-05-01
• First posted: 2007-12-11
• Last updated: 2017-03-15
• Results posted: 2017-03-15

Locations

1 site across 1 country: United States