Loading clinical trials...

COMPLETEDPHASE1

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

Safety and Pharmacokinetics of Lisinopril in Pediatric Kidney Transplant Recipients

NCT01491919•Uptal Patel

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.

Eligibility

Age

2 - 17 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Kidney transplant recipient
•2. Age 2-17 years, inclusive, at the time of first study dose
•3. Estimated GFR (eGFR) ≥30 ml/min/1.73m2, with stable allograft function as indicated by \<20% change in serum creatinine in the previous 30 days
•4. Stable immunosuppressive regimen, as indicated by \<10% change in dosage (in mg/kg) in these medications, within the 14 days prior to enrollment
•5. Systolic BP \>90th percentile for age, gender, and height, necessitating initiation or addition of an antihypertensive medication
•6. For females of child-bearing potential, a negative serum pregnancy test prior to initial dosing and agreement to practice appropriate contraceptive measures, including abstinence, from the time of the initial pregnancy testing through the remainder of the study (30 days after last administration of investigational agents).

Exclusion Criteria

•1. History of anaphylaxis attributable to lisinopril or other angiotensin-converting enzyme inhibitor (ACEI) agents (e.g.,enalapril, ramipril, quinapril)
•2. History of anaphylaxis attributable to iohexol or an iodine hypersensitivity
•3. Use of an angiotensin-converting enzyme inhibitor (ACEI), angiotensin receptor blocker, or renin antagonist within 30 days prior to enrollment
•4. Stage 2 hypertension defined as the \>99th percentile for age, height and gender + 5 mm Hg
•5. Blood Potassium value \> 6.0 milliequivalent / liter (mEq/L) (as determined at the screening visit)
•6. Previous participation in this study
•7. Physician concern that the participant may not adhere to the study protocol, based on prior behavior
•8. Current plasmapheresis treatment
•9. History of angioedema
•10. Pregnancy

Locations (7)

University of Alabama

Birmingham, Alabama, United States

Arkansas Children's Hospital

Little Rock, Arkansas, United States

Emory University and Children's Healthcare of Atlanta

Atlanta, Georgia, United States

University of Michigan

Ann Arbor, Michigan, United States

Children's Mercy Hospitals & Clinics

Kansas City, Missouri, United States

New York University Langone Medical Center

New York, New York, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Key Dates

Start Date

June 1, 2012

Primary Completion Date

September 1, 2013

Completion Date

September 1, 2013

Last Updated

July 8, 2015

Enrollment

ACTUAL participants

Conditions

Hypertension

Interventions

Lisinopril

DRUG

Natural History of Noncirrhotic Portal Hypertension

NCT02417740

Cystic FibrosisImmunologic Deficiency Syndrome+3 more

View study

RECRUITING

Homocysteine and Early Diastolic Dysfunction in Newly Diagnosed Hypertension

NCT07480265

Hypertension (HTN)Hyperhomocysteinemia+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 8, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Natural History of Noncirrhotic Portal Hypertension

Homocysteine and Early Diastolic Dysfunction in Newly Diagnosed Hypertension

A Study to Learn About the Study Medicine (Called PF-07868489) in People With Pulmonary Arterial Hypertension Who Have Previously Participated in a Clinical Study With PF-07868489

Mobile Cued Adherence Therapy (mCAT) for Blood Pressure Medication

Penn Medicine Healthy Heart

Preliminary Human Trials of F230 Tablets