Single Dose Pravastatin Pharmacokinetics in Pediatric Peritoneal Dialysis Patients

This study is currently recruiting participants.

Verified by Arkansas Children's Hospital Research Institute, August 2008

Sponsored by:	Arkansas Children's Hospital Research Institute
Information provided by:	Arkansas Children's Hospital Research Institute
ClinicalTrials.gov Identifier:	NCT00571194

Purpose

Many children with end stage renal disease develop hyperlipidemia.HMG-CoA 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.

Condition	Intervention
Pediatrics Patients on Dialysis	Drug: pravastatin

MedlinePlus related topics: Children's Health Kidney Failure

Drug Information available for: Pravastatin Pravastatin sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Open Label, Single Group Assignment, Pharmacokinetics Study
Official Title:	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

Further study details as provided by Arkansas Children's Hospital Research Institute:

Primary Outcome Measures:

pharmacokinetics [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Estimated Enrollment:	7
Study Start Date:	September 2007
Estimated Study Completion Date:	January 2010

Arms	Assigned Interventions
1: Experimental Study drug given and have levels done to measure pharmacokinetics	Drug: pravastatin single dose

Eligibility

Ages Eligible for Study:	12 Months to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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: AST,ALT, 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 -

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00571194

Contacts

Contact: Eileen N Ellis, MD

501-364-1847

elliseileenn@uams.edu

Locations

United States, Arkansas
Arkansas Children's Hospital	Recruiting
Little Rock, Arkansas, United States, 72202
Contact: Eileen N Ellis, MD 501-364-1847 elliseileenn@uams.edu
Principal Investigator: Eileen N Ellis, MD

Sponsors and Collaborators

Arkansas Children's Hospital Research Institute

Investigators

Principal Investigator:

Eileen N Ellis, MD

Arkansas Children's Hospital Research Institute

More Information

Responsible Party:	Arkansas Children's Hospital ( Eileen Ellis, MD )
Study ID Numbers:	75611
Study First Received:	December 10, 2007
Last Updated:	August 18, 2008
ClinicalTrials.gov Identifier:	NCT00571194
Health Authority:	United States: Institutional Review Board

Keywords provided by Arkansas Children's Hospital Research Institute:

pravastatin, peritoneal dialysis, pediatric patients

Study placed in the following topic categories:

Pravastatin

Additional relevant MeSH terms:

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antilipemic Agents

Enzyme Inhibitors
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 13, 2009