Safety and Pharmacokinetics of Lisinopril in Pediatric Kidney Transplant Recipients

Identifying the best dose of lisinopril to reduce high blood pressure in children who have received a kidney transplant.

This study is examining the pharmacokinetics of lisinopril in pediatric kidney transplant recipients. The study is enrolling approximately 28 children aged 2-17 years who have stable allograft function and need medication therapy to control high blood pressure. The study is open to children of both sexes and all racial and ethnic groups. Each child participates in the study for up to 51 days (includes 7 days of screening, 14 days of drug administration, and 30 days of safety monitoring).

Uptal Patel, MD, of Duke Clinical Research Institute, discusses the lisinopril in pediatric kidney transplant recipients study.

Summary

Lisinopril is approved by the U.S. Food and Drug Administration for the treatment of high blood pressure (hypertension) in adults and children aged 6+ years. 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 vulnerable group is also unknown.

We will administer lisinopril to children and adolescents who have high blood pressure and have received a kidney transplant. The levels of lisinopril in each person will be measured, thereby allowing the determination of the best dose of lisinopril to reduce high blood pressure in this fragile population. It is likely that the drug behaves differently in young children and in children and adolescents who have received a kidney transplant than it does in older children and adults.

We are enrolling up to 28 children and adolescents between 2-17 years of age with a kidney transplant that is working well. Lisinopril is given for up to 14 days, and the participants are monitored for another 30 days for any drug side effects.

Publications

Pharmacokinetics, Pharmacodynamics, and Safety of Lisinopril in Pediatric Kidney Transplant Patients: Implications for Starting Dose Selection. 
Trachtman H, Frymoyer A, Lewandowski A, Greenbaum LA, Feig DI, Gipson DS, Warady BA, Goebel JW, Schwartz GJ, Lewis K, Anand R, Patel UD; Best Pharmaceuticals for Children Act-Pediatric Trials Network Administrative Core Committee.
Clinical Pharmacology Therapy• July 2015, volume 98, issue 1, pages 25-33.
PMCID: PMC4536255 [Free access available on 7/1/2016]

OVERVIEW

Status:
Clinical study report submitted to FDA

ClinicalTrials.gov identifier:
NCT01491919

Principal Investigators:
Howard Trachtman, MD
New York University Langone Medical Center
New Hyde Park, NY

Uptal Patel, MD
Duke Health, Durham, NC

NEWS

  • Lisinopril label change May 20, 2016 The FDA changed the drug label for lisinopril to reflect findings from a study conducted by PTN investigators. Results from the study were published in the journal, Clinical Pharmacology &Therapeutics.
  • PTN lisinopril study and subsequent label change highlighted in DCRI News. May 12, 2016 Pediatric Trials Network study results in label change for hypertension drug May 11, 2016 – The change could affect the hundreds of children who are prescribed lisinopril after kidney transplants each year. A study conducted by the Pediatric Trials Network (PTN) has resulted in a labelling change for a widely used drug. Lisinopril is an angiotensin converting enzyme inhibitor that ...
  • The PTN lisinopril study completes enrollment September 3, 2013 In spite of the challenges posed by its complex protocol, the “Safety and Pharmacokinetics of Lisinopril in Pediatric Kidney Transplant Recipients” study has completed enrollment, with a total of 26 patients contributing data to this study of lisinopril use for the control of high blood pressure in kids receiving kidney transplants. This accomplishment is due to ...
  • PTN lisinopril study enrolls first participant June 25, 2012 Principal investigator Daniel Feig, MD, PhD, of University of Alabama-Birmingham has successfully enrolled the first participant into the PTN study of lisinopril use for the control of high blood pressure in kids with kidney transplants. Seven sites are currently recruiting participants into this study: Arkansas Children’s Hospital in Little Rock, Cincinnati Children’s Hospital, Children’s Mercy Hospital ...
  • The PTN lisinopril study is now looking for participants to enroll at four active sites May 17, 2012 Four sites are now actively seeking participants to enroll into the PTN study of lisinopril for the control of high blood pressure in kids with kidney transplants: University of Alabama–Birmingham, Arkansas Children’s Hospital in Little Rock, University of Michigan at Ann Arbor, and New York University Langone Medical Center. Lisinopril is a drug used in children ...