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Single Dose Pravastatin Pharmacokinetics in Pediatric Peritoneal Dialysis Patients

Primary Purpose

End Stage Renal Disease

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
pravastatin
Sponsored by
Arkansas Children's Hospital Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for End Stage Renal Disease focused on measuring pravastatin, peritoneal dialysis, pediatric patients

Eligibility Criteria

12 Months - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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 -

Sites / Locations

  • Arkansas Children's Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

peritoneal dialysis (CCPD)

Arm Description

PK profile of pravastatin

Outcomes

Primary Outcome Measures

Pharmacokinetics

Secondary Outcome Measures

Full Information

First Posted
December 10, 2007
Last Updated
January 26, 2017
Sponsor
Arkansas Children's Hospital Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00571194
Brief Title
Single Dose Pravastatin Pharmacokinetics in Pediatric Peritoneal Dialysis Patients
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 Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Terminated
Study Start Date
September 2007 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arkansas Children's Hospital Research Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease
Keywords
pravastatin, peritoneal dialysis, pediatric patients

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
peritoneal dialysis (CCPD)
Arm Type
Other
Arm Description
PK profile of pravastatin
Intervention Type
Drug
Intervention Name(s)
pravastatin
Other Intervention Name(s)
Pravachol
Intervention Description
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
Primary Outcome Measure Information:
Title
Pharmacokinetics
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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: Aspartate aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine phosphokinase(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 -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eileen N Ellis, MD
Organizational Affiliation
Arkansas Children's Hospital Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arkansas Children's Hospital
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to share the data

Learn more about this trial

Single Dose Pravastatin Pharmacokinetics in Pediatric Peritoneal Dialysis Patients

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