Safety Study of Lisinopril in Children and Adolescents With a Kidney Transplant
Status:
Completed
Trial end date:
2013-09-01
Target enrollment:
Participant gender:
Summary
The drug lisinopril is approved by the U.S. Food and Drug Administration for the treatment of
high blood pressure, heart failure, and acute heart attacks in adult patients. In children
over 6 years of age, lisinopril is approved for the treatment of high blood pressure.
Lisinopril is in a group of medications called angiotensin-converting enzyme inhibitors
(ACE). ACE inhibitors such as lisinopril work by decreasing certain chemicals that tighten
the blood vessels so blood flows more smoothly and the heart can pump blood more efficiently.
There is some information available about how children with high blood pressure absorb,
distribute, metabolize, and eliminate lisinopril (this information about medication
processing by the body is called pharmacokinetic data). However, there is no information
about how children with high blood pressure who have received a kidney transplant process
lisinopril. In addition to decreasing blood pressure, investigators believe that lisinopril
may help kidney transplants work longer by reducing the activity of chemicals made by cells
in kidney transplants that can lead to inflammation and injury. Such benefits have not been
found with another group of blood pressure medications called calcium channel blockers, which
are the most commonly used medication group to control high blood pressure in children after
a kidney transplant. A clinical trial will be conducted in the future to compare which
medication group helps kidney transplants in children last longer. To guide the selection of
the best dose to test in future studies, investigators in this study will try to determine
the safety profile, dose tolerability, and pharmacokinetics of lisinopril in children and
adolescents (2-17 years of age) who have received a kidney transplant and have high blood
pressure.
Phase:
Phase 1
Details
Lead Sponsor:
Uptal Patel
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) OpAns, LLC The Emmes Company, LLC The EMMES Corporation University of Rochester