Nebivolol Effect on Nitric Oxide Levels, Blood Pressure, and Renal Function in Kidney Transplant Patients

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01157234
First received: July 2, 2010
Last updated: November 19, 2013
Last verified: November 2013
  Purpose

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 SNS activation and decreased prostaglandin and nitric oxide production. Hypotheses:

  1. Nebivolol is more beneficial than metoprolol in favorably affecting markers of oxidative stress in hypertensive renal transplant patients.
  2. Nebivolol has a better impact than metoprolol on kidney function among hypertensive renal transplant patients

Condition Intervention Phase
Hypertension
Kidney Transplantation
Drug: Nebivolol
Drug: Metoprolol
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Nebivolol Effect on Nitric Oxide Levels, Blood Pressure, and Renal Function in Kidney Transplant Patients

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • To determine the effect of nebivolol versus metoprolol on serum nitric oxide levels in hypertensive renal transplant patients [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the effect of nebivolol versus metoprolol on markers for oxidative stress. [ Time Frame: One Year ] [ Designated as safety issue: No ]
  • To determine the effect of nebivolol versus metoprolol on renal function in hypertensive renal transplant patients. [ Time Frame: One Year ] [ Designated as safety issue: No ]
  • To determine the effect of nebivolol versus metoprolol on blood pressure control in hypertensive renal transplant patients. [ Time Frame: One Year ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: July 2010
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Nebivolol Drug: Nebivolol
Nebivolol 5 mg once daily, titrated to a maximum total daily dose of 40 mg to achieve a blood pressure of < 140/ 90.
Other Name: Bystolic
Active Comparator: Metoprolol Drug: Metoprolol
Metoprolol 25 mg twice daily, titrated to a maximum total daily dose of 400 mg to achieve a blood pressure < 140/90.
Other Name: Lopressor

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • Any contraindication to taking beta-blockers, specifically Nebivolol or Metoprolol. Conditions such as : (bradycardia 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 SBP > 210 or DBP > 120 mm Hg.
  • Symptomatic hypotension
  • Previous intolerance to beta blockers
  • Cerebrovascular accident within 3 months of randomization
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01157234

Locations
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
University of Florida
Forest Laboratories
Investigators
Principal Investigator: Alfonso Santos, MD University of Florida
  More Information

Publications:
Sharma SP. Nitric oxide and the kidney: Review. Indian Journal of Nephrology 2004;14: 77-84.
Schwenger V, Zeier M, Ritz E. Hypertension after renal transplantation. Ann Transplant. 2001;6:25-30.

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01157234     History of Changes
Other Study ID Numbers: BYS-MD-42
Study First Received: July 2, 2010
Last Updated: November 19, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
Hypertension
Kidney Transplantation
Beta-blockers
Nitric Oxide
Nebivolol

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Metoprolol
Nebivolol
Metoprolol succinate
Nitric Oxide
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents
Anti-Asthmatic Agents
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Protective Agents

ClinicalTrials.gov processed this record on July 24, 2014