This study is examining the pharmacokinetics of lisinopril in pediatric kidney transplant recipients. The study is enrolling approximately 28 children aged 2-17 years who have stable allograft function and need medication therapy to control high blood pressure. The study is open to children of both sexes and all racial and ethnic groups. Each child participates in the study for up to 51 days (includes 7 days of screening, 14 days of drug administration, and 30 days of safety monitoring).
Uptal Patel, MD, of Duke Clinical Research Institute, discusses the lisinopril in pediatric kidney transplant recipients study.
Lisinopril is approved by the U.S. Food and Drug Administration for the treatment of high blood pressure (hypertension) in adults and children aged 6+ years. However, the appropriate dose of lisinopril in children below the age of 6 is not well known. In addition, high blood pressure is common among children and adolescents who have received a kidney transplant, but the appropriate dose of lisinopril in this vulnerable group is also unknown.
We will administer lisinopril to children and adolescents who have high blood pressure and have received a kidney transplant. The levels of lisinopril in each person will be measured, thereby allowing the determination of the best dose of lisinopril to reduce high blood pressure in this fragile population. It is likely that the drug behaves differently in young children and in children and adolescents who have received a kidney transplant than it does in older children and adults.
We are enrolling up to 28 children and adolescents between 2-17 years of age with a kidney transplant that is working well. Lisinopril is given for up to 14 days, and the participants are monitored for another 30 days for any drug side effects.
Pharmacokinetics, Pharmacodynamics, and Safety of Lisinopril in Pediatric Kidney Transplant Patients: Implications for Starting Dose Selection.
Trachtman H, Frymoyer A, Lewandowski A, Greenbaum LA, Feig DI, Gipson DS, Warady BA, Goebel JW, Schwartz GJ, Lewis K, Anand R, Patel UD; Best Pharmaceuticals for Children Act-Pediatric Trials Network Administrative Core Committee.
Clinical Pharmacology Therapy• July 2015, volume 98, issue 1, pages 25-33.
PMCID: PMC4536255 [Free access available on 7/1/2016]
Clinical study report submitted to FDA
Howard Trachtman, MD
New York University Langone Medical Center
New Hyde Park, NY
Uptal Patel, MD
Duke Health, Durham, NC
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