Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:30 AM
Ignite Modification Date:
2025-12-25 @ 1:30 AM
NCT ID:
NCT00571194
Brief 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.
Study:
NCT00571194
Study Brief:
Protocol Section:
NCT00571194