Efficacy and Tolerability of Nebivolol Versus Sustained Release Metoprolol Succinate in Patients With Chronic Kidney Disease: A Single-center Randomized Trial.
Sponsor study identifier
observational
50
1 country
1
Study Start
March 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2014
Actual (reported)Study Completion
January 2014
Actual (reported)The investigators postulate that nebivolol will be more effective than an equivalent dose of a comparative BB, specifically sustained release metoprolol succinate, in improving the availability of NO, lowering blood pressure, and reducing albuminuria with implications for slowing progression of CKD and cardiovascular protection in this high risk population. The objective of this proposal is to conduct a randomized pilot clinical trial to determine the relative efficacy and tolerability of nebivolol versus sustained release metoprolol succinate in improving blood pressure in patients with CKD and albuminuria. The primary endpoint would be a decrease in asymmetric dimethyl arginine (ADMA). Secondary endpoints would include a reduction in blood pressure, urinary F2-isoprostanes and albuminuria.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2014
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 8, 2011
Actual (reported)February 9, 2011
Actual (reported)March 2011
Date type not reportedThis date has not been verified as actual or estimated.
January 2014
Actual (reported)January 2014
Actual (reported)Primary Efficacy
The primary efficacy variable will be the change in ADMA level from baseline to end of study.
Baseline to End of Study
Secondary Efficacy
Baseline to End of Study
A total of 50 patients with CKD meeting the inclusion and exclusion criteria listed below will after informed consent be randomized to either nebivolol or sustained release metoprolol succinate and followed for 3 months or early termination of the study.
University of Michigan Health Systems
Ann Arbor, Michigan, 48109, United States
A total of 30 ml blood (CBC with differential and platelets-3ml, comprehensive panel-5-7ml, biomarkers-20ml) will be drawn by venipuncture typically from the antecubital vein at baseline visit (30ml), and week 6-study midpoint (30ml) and end of study (30ml). At the screening visit only 10ml blood will be required (CBC and Comprehensive Panel).
Rajiv Saran, MD, MS, MRCP
University of Michigan
50 participants (actual enrollment reported by the registry).
First Submitted
February 8, 2011
First Posted
February 9, 2011
Study Start
March 2011
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
January 2014
Actual (reported)Study Completion
January 2014
Actual (reported)Last Updated
August 5, 2015
Record last verified: 2015-08
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Source: ClinicalTrials.gov.
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