Safety and Pharmacokinetics of Lisinopril in Pediatric Kidney Transplant Recipients

NICHD-2011-HTN01 was a prospective, open-label, multiple center, pharmacokinetics (PK) study of lisinopril in pediatric kidney transplant recipients, aged 2-17 years of age, with stable allograft function and need of medication therapy to control hypertension. The primary objective was to evaluate the safety profile and PK of oral lisinopril. Out of 29 screened participants, 26 received study medication at varying doses and were included in the safety population. Fifteen participants were lisinopril naive and received protocol specific treatment, while eleven received continuing lisinopril as part of standard of care treatment. Twenty-two participants had evaluable PK measurements and were included in the PK analysis population. Overall, lisinopril PK in children with a kidney transplant were comparable to historical groups of children and adults without a kidney transplant. One SAE was reported as unrelated to lisinopril, and one AE led to study drug discontinuation. Otherwise, AE rates were low.