Lisinopril is approved by the U.S. Food and Drug Administration for the treatment of children ages 6 years and older and adults with high blood pressure (hypertension), heart failure, and heart attack. Children and adolescents may be affected by high blood pressure, too, therefore doctors frequently give lisinopril to children and adolescents who need medication to control hypertension. 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 group is also not well known.
My name is up top and i’m one of the investigators for the lisinopril study in pediatric adolescents and children who have received kidney transplants i have been on faculty here at duke university and work at the duke clinical research institute and ma pediatric and adult nephrologist by training this trial is a study of lisinopril in two phases the first part
Will be understanding ways to dose the drug better and in the second part will be evaluating its effect on blood pressure and to inform longer-term outcomes the trial is in children and adolescents who received a kidney transplant high blood pressure is very common and people who’ve had kidney transplants and controlling it for the long term is something that we
Know very little about and one of the goals is to understand if controlling blood pressure more closely in these children and adolescents is something that will be helpful for them especially in the long term most children and adolescents who survived into adulthood with a kidney transplant are at very high risk for cardiovascular disease as young adults and so we
Believe that it’s important to evaluate the impact of controlling blood pressure earlier in their lives in order to allow them a greater chance for positive outcomes and general improved health as they get older so lisinopril is a very commonly used drug for blood pressure and in adults a variety of other indications like treatment for heart failure and after heart
Attacks it seems to help prevent the heart from having more trouble alright so it’s been used for a long time but not as long in children so this will be the first study to evaluate lisinopril in young children ages two to six we have very little information on how best to dose the drug in that age group so this would be very important informative for understanding
The best way to dose this drug that’s commonly used treatment of hypertension in children and adolescents we’re very excited about starting to begin the startup phase of our study and we are planning the first patient enrollment hopefully within the next one to two months and hope to recruit for about 8 to 12 months and be finished sometime in the third quarter of
Next year there are eight sites currently that we have in the through the pediatric trials network and hopefully we’re recruiting relatively evenly across those sites so we did meet with the fda about this drug and our plans to study it in children and adolescents with a kidney transplant will be getting very good information about optimal dosing in this population
That will inform the next phase of this study which will be a trial to evaluate the safety and efficacy of it or how well it works and how safe it is actually in this population
Transcribed from video
From the Pediatric Trials Network: Lisinopril in pediatric kidney transplant recipients By pediatrictrials
