Nebivolol Versus Sustained Release Metoprolol Succinate in Patients With Chronic Kidney Disease
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.
Chronic Kidney Disease
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Efficacy and Tolerability of Nebivolol Versus Sustained Release Metoprolol Succinate in Patients With Chronic Kidney Disease: A Single-center Randomized Trial.|
- Primary Efficacy [ Time Frame: Baseline to End of Study ] [ Designated as safety issue: No ]The primary efficacy variable will be the change in ADMA level from baseline to end of study.
- Secondary Efficacy [ Time Frame: Baseline to End of Study ] [ Designated as safety issue: No ]Secondary efficacy parameters will include: the change in blood pressure, GFR, urinary albumin excretion, and biomarkers including urinary F2-Isoprostanes, BNP, hsCRP, Cystatin C, and a measure of insulin resistance-the homeostatic model assessment (HOMA) from baseline to end of study
Biospecimen Retention: Samples Without DNA
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).
|Study Start Date:||March 2011|
|Estimated Study Completion Date:||September 2013|
|Estimated Primary Completion Date:||February 2013 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01291888
|Contact: Rajiv Saran, MBBS MD MS MRCPfirstname.lastname@example.org|
|Contact: Manilay K Pulsinelli, BSemail@example.com|
|United States, Michigan|
|University of Michigan Health Systems||Recruiting|
|Ann Arbor, Michigan, United States, 48109|
|Contact: Rajiv Saran, MD, MS, MRCP 734-763-1521 firstname.lastname@example.org|
|Contact: Manilay K Pulsinelli, BS 734-763-4268 email@example.com|
|Principal Investigator:||Rajiv Saran, MD, MS, MRCP||University of Michigan|