Safety Study of Lisinopril in Children and Adolescents With a Kidney Transplant

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.

Conditions

• Hypertension

Interventions

DRUG

Lisinopril

Subjects will be randomized to Low, Medium, or High dose of Lisinopril

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  collaborator NIH

• The Emmes Company, LLC

  collaborator INDUSTRY

• University of Rochester

  collaborator OTHER

• OpAns, LLC

  collaborator UNKNOWN

• Uptal Patel

  lead OTHER

Principal Investigators

• Daniel Benjamin, MD, PhD, MPH · Duke University

• Howard Trachtman, MD · NYU Langone Health

• Uptal D Patel, MD · Duke University

• Adam Frymoyer, MD · Stanford University

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

2 Years

Max Age

17 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-06-30

Primary Completion

2013-09-30

Completion

2013-09-30

Countries

• United States

Study Locations