Single Dose Pravastatin Pharmacokinetics in Pediatric Peritoneal Dialysis Patients

NCT00571194 | Terminated Phase 1 Results

• 1 other identifier: 75611
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

End Stage Renal Disease

Keywords

pravastatin, peritoneal dialysis, pediatric patients

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetics

  24 hours

Study Arms (1)

peritoneal dialysis (CCPD)

OTHER

PK profile of pravastatin

Drug: pravastatin

Interventions

pravastatin DRUG

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

Also known as: Pravachol

peritoneal dialysis (CCPD)

Eligibility Criteria

• Age: 12 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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 -

Sponsors & Collaborators

• Arkansas Children's Hospital Research Institute: lead

Study Sites (1)

Arkansas Children's Hospital

Little Rock, Arkansas, 72202, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Pravastatin

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Results Point of Contact

• Title: Dr. Eileen Ellis
• Organization: Arkansas Children's Hospital

elliseileenn@uams.edu

501-364-1847

Study Officials

• Eileen N Ellis, MD

  Arkansas Children's Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2007
• First Posted: December 11, 2007
• Study Start: September 1, 2007
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: March 15, 2017
• Results First Posted: March 15, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)