Status:
COMPLETED
Safety Study of Lisinopril in Children and Adolescents With a Kidney Transplant
Lead Sponsor:
Uptal Patel
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
The Emmes Company, LLC
Conditions:
Hypertension
Eligibility:
All Genders
2-17 years
Phase:
PHASE1
Brief 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...
Eligibility Criteria
Inclusion
- Kidney transplant recipient
- Age 2-17 years, inclusive, at the time of first study dose
- 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
- Stable immunosuppressive regimen, as indicated by \<10% change in dosage (in mg/kg) in these medications, within the 14 days prior to enrollment
- Systolic BP \>90th percentile for age, gender, and height, necessitating initiation or addition of an antihypertensive medication
- 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
- History of anaphylaxis attributable to lisinopril or other angiotensin-converting enzyme inhibitor (ACEI) agents (e.g.,enalapril, ramipril, quinapril)
- History of anaphylaxis attributable to iohexol or an iodine hypersensitivity
- Use of an angiotensin-converting enzyme inhibitor (ACEI), angiotensin receptor blocker, or renin antagonist within 30 days prior to enrollment
- Stage 2 hypertension defined as the \>99th percentile for age, height and gender + 5 mm Hg
- Blood Potassium value \> 6.0 milliequivalent / liter (mEq/L) (as determined at the screening visit)
- Previous participation in this study
- Physician concern that the participant may not adhere to the study protocol, based on prior behavior
- Current plasmapheresis treatment
- History of angioedema
- Pregnancy
Key Trial Info
Start Date :
June 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT01491919
Start Date
June 1 2012
End Date
September 1 2013
Last Update
July 8 2015
Active Locations (7)
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1
University of Alabama
Birmingham, Alabama, United States, 35233
2
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
3
Emory University and Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
4
University of Michigan
Ann Arbor, Michigan, United States, 48109