Single Dose Pravastatin Pharmacokinetics in Pediatric Peritoneal Dialysis Patients

• Sponsor: Arkansas Children's Hospital Research Institute (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00571194
• Collaborator: (none)
• Enrollment: 7
• Location: 1
• Arm: 1
• Duration (Months): 20
• Patients Per Site Per Month: 0.4

Study Details

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.

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 Design

• Study Type: Interventional
• Actual Enrollment: 7 participants
• Allocation: N/A
• 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: Sep 1, 2007
• Actual Primary Completion Date: May 1, 2009
• Actual Study Completion Date: May 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Other: 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 Names: Pravachol

Outcome Measures

Primary Outcome Measures

1. Pharmacokinetics [24 hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Months to 18 Years
• 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 -

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arkansas Children's Hospital	Little Rock	Arkansas	United States	72202

Sponsors and Collaborators

• Arkansas Children's Hospital Research Institute

Investigators

• Principal Investigator: Eileen N Ellis, MD, Arkansas Children's Hospital Research Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Arkansas Children's Hospital Research Institute
• ClinicalTrials.gov Identifier: NCT00571194
• Other Study ID Numbers: 75611
• First Posted: Dec 11, 2007
• Last Update Posted: Mar 15, 2017
• Last Verified: Jan 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Arkansas Children's Hospital Research Institute: pravastatin, peritoneal dialysis, pediatric patients
• Additional relevant MeSH terms: Kidney Failure, Chronic; Pravastatin

Study Results

Participant Flow

Arm/Group Title	Pravastatin
Arm/Group Description	Study drug given and have levels done to measure pharmacokinetics.
Period Title: Overall Study
STARTED	7
COMPLETED	7
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	A Single-Dose Pilot Study
Arm/Group Description	Study drug given and have levels done to measure pharmacokinetics
Overall Participants	7
Age (Count of Participants)
<=18 years	7 100%
Between 18 and 65 years	0 0%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	4 57.1%
Male	3 42.9%
Region of Enrollment (participants) [Number]
United States	7 100%

Outcome Measures

1. Primary Outcome

Title	Pharmacokinetics
Time Frame	24 hours

Outcome Measure Data

Analysis Population Description

Data was not collected

Arm/Group Title	A Single-Dose Pilot Study
Arm/Group Description	Study drug given and have levels done to measure pharmacokinetics
Measure Participants	0

Adverse Events

Arm/Group Title	A Single-Dose Pilot Study
Arm/Group Description	Study drug given and have levels done to measure pharmacokinetics
All Cause Mortality
	A Single-Dose Pilot Study
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	A Single-Dose Pilot Study
	Affected / at Risk (%)	# Events
Total	0/7 (0%)
Other (Not Including Serious) Adverse Events
	A Single-Dose Pilot Study
	Affected / at Risk (%)	# Events
Total	0/7 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.