Single Dose Pravastatin Pharmacokinetics in Pediatric Peritoneal Dialysis Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00571194
Recruitment Status : Terminated
First Posted : December 11, 2007
Results First Posted : March 15, 2017
Last Update Posted : March 15, 2017
Information provided by (Responsible Party):
Arkansas Children's Hospital Research Institute

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.

Condition or disease Intervention/treatment Phase
End Stage Renal Disease Drug: pravastatin Phase 1

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Study Start Date : September 2007
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Failure
U.S. FDA Resources

Arm Intervention/treatment
peritoneal dialysis (CCPD)
PK profile of pravastatin
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

Other Name: Pravachol

Primary Outcome Measures :
  1. Pharmacokinetics [ Time Frame: 24 hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00571194

United States, Arkansas
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
Sponsors and Collaborators
Arkansas Children's Hospital Research Institute
Principal Investigator: Eileen N Ellis, MD Arkansas Children's Hospital Research Institute

Responsible Party: Arkansas Children's Hospital Research Institute Identifier: NCT00571194     History of Changes
Other Study ID Numbers: 75611
First Posted: December 11, 2007    Key Record Dates
Results First Posted: March 15, 2017
Last Update Posted: March 15, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share the data

Keywords provided by Arkansas Children's Hospital Research Institute:
pravastatin, peritoneal dialysis, pediatric patients

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors