Nebivolol Versus Sustained Release Metoprolol Succinate in Patients With Chronic Kidney Disease
|ClinicalTrials.gov Identifier: NCT01291888|
Recruitment Status : Completed
First Posted : February 9, 2011
Last Update Posted : August 5, 2015
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.
|Condition or disease|
|Chronic Kidney Disease|
Show Detailed Description
|Study Type :||Observational|
|Actual Enrollment :||50 participants|
|Official Title:||Efficacy and Tolerability of Nebivolol Versus Sustained Release Metoprolol Succinate in Patients With Chronic Kidney Disease: A Single-center Randomized Trial.|
|Study Start Date :||March 2011|
|Actual Primary Completion Date :||January 2014|
|Actual Study Completion Date :||January 2014|
- Primary Efficacy [ Time Frame: Baseline to End of Study ]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 ]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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01291888
|United States, Michigan|
|University of Michigan Health Systems|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Rajiv Saran, MD, MS, MRCP||University of Michigan|