Status:
COMPLETED
Nebivolol Effect on Nitric Oxide Levels, Blood Pressure, and Renal Function in Kidney Transplant Patients
Lead Sponsor:
University of Florida
Collaborating Sponsors:
Forest Laboratories
Conditions:
Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This study will investigate the blood pressure lowering efficacy of nebivolol among renal transplant recipients who are on calcineurin inhibitors which are believed to contribute to hypertension by sy...
Detailed Description
Nitric Oxide (NO) plays a plethora of functions in the kidney including vascular and hemodynamic regulation, fluid and electrolyte transport, and is an important component of pressure natriuresis and ...
Eligibility Criteria
Inclusion
- Men or women at least 18 years of age who are recipients of - a solitary kidney or combined kidney-pancreas transplant within the last twenty four months
- Current diagnosis of hypertension
- Normal hepatic enzymes
- Estimated creatinine clearance (by cockcroft-gault formula) \>or= 30 ml/min
Exclusion
- Any contraindication to taking beta-blockers, specifically Nebivolol or Metoprolol. Conditions such as : (bradycardia heart rate (HR) \<60 beats per minute , heart block \> 1st degree, decompensated cardiac failure, sick sinus syndrome (unless permanent pacemaker in place), severe hepatic impairment( defined as elevation of aspartamine aminotransferase , alanine aminotransferase, or bilirubin levels to three times upper limit of normal reference range), severe peripheral arterial circulatory disorder, history of bronchospasm and /or asthma and /or regular medication with inhaled bronchodilators. or , or any medical condition that in the opinion of the investigator may interfere with the subject's ability to successfully complete the protocol.
- Any medical condition which, in the opinion of the Principal Investigator, might compromise the safety of the subject in participating in the protocol such as hypotension or not requiring antihypertensive medications.
- Any serious systemic disease that might complicate management and reduce life expectancy.
- Uncontrolled hypertension defined as systolic blood pressure (SBP) \> 210 or diastolic blood pressure (DBP) \> 120 mm Hg.
- Symptomatic hypotension
- Previous intolerance to beta blockers
- Cerebrovascular accident within 3 months of randomization
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01157234
Start Date
July 1 2010
End Date
July 1 2014
Last Update
November 6 2024
Active Locations (1)
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1
University of Florida
Gainesville, Florida, United States, 32610