End Stage Renal Disease
Conditions
Keywords
pravastatin, peritoneal dialysis, pediatric patients
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.
Interventions
DRUGpravastatin
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
Sponsors
Arkansas Children's Hospital Research Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Months to 18 Years
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 -
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics | 24 hours |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| A Single-Dose Pilot Study Study drug given and have levels done to measure pharmacokinetics | 7 |
| Total | 7 |
Baseline characteristics
| Characteristic | A Single-Dose Pilot Study |
|---|---|
| Age, Categorical <=18 years | 7 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Region of Enrollment United States | 7 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 7 |
| serious Total, serious adverse events | 0 / 7 |
Outcome results
Primary
Pharmacokinetics
Time frame: 24 hours
Population: Data was not collected