Chronic Kidney Disease | Nebivolol Versus Sustained Release Metoprolol Succinate in Patients With Chronic Kidney Disease
Chronic Kidney Disease research study
What is the primary objective of this study?
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.
Who is eligible to participate?
Inclusion Criteria: - Age > 18 years old and < 85 years old - Willing and able to comply with all study procedures - Blood pressure on standard antihypertensive therapy, which may include: a diuretic, ACE-I, ARB, CCB, and/or an alpha adrenergic antagonist, and a blood pressure ≤ 180 mm Hg systolic and ≥ 130 mm Hg systolic. The blood pressure will be taken after a period of 15 minutes of resting in the sitting posture - Clinically stable patients with CKD (GFR 20-60 ml/min/1.73 m²) by the abbreviated MDRD equation and with a rate of decline of GFR no greater than 1 ml/min/1.73 m² per month over the prior three months and with albuminuria (urine albumin:creatinine ratio) in a spot urine sample of between 100-3000 mcg/g of creatinine). Albumin excretion (i.e., urine albumin:creatinine ratio) will be checked prior to enrollment in two separate (collected at least one week apart) spot early morning urine specimens - Females of child bearing potential must have a negative pregnancy test at screening. Females considered not of childbearing potential include those who have been in menopause at least 2 years, had tubal ligation at least 1 year prior to screening or who have had a total hysterectomy Exclusion Criteria: - Use of a BB in the 3 months prior to study enrollment, other than atenolol or metoprolol - Uncontrolled hypertension with a blood pressure > 160/100 mm Hg or those with changes to their antihypertensive regime during the last 2 months - Concurrent disease or conditions that would interfere with study participation or safety, such as bleeding disorders, history of syncope or vertigo, severe gastrointestinal reflux (GERD) or gastric ulcers, heart failure, symptomatic coronary or peripheral vascular disease, arrhythmia, serious neurological disorders including seizures or organ transplantation - Diabetics that are uncontrolled (HbA1c consistently > 9.0 g/dL), unstable, newly diagnosed, or have undergone major changes in therapy within the last 2 months - Any severe co-morbid condition that would limit life expectancy to < 6 months - Advanced CKD with an eGFR < 20 ml/min/1.73 m² - Patients with albuminuria due to causes other than diabetes mellitus or hypertension - Hepatic enzyme concentrations > 2 times the upper limit of normal - HIV infection, hepatic cirrhosis or other preexisting liver disease; or positive HIV, Hepatitis B or C test at screening - Use of any investigational product or investigational medical device within the last 60 days of screening - History of alcohol and or drug abuse - Any condition that in view of the investigators places the subject at high risk of poor treatment or compliance or of not completing the study
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Chronic Kidney Disease
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Start Date: March 2011
Completed Date: January 2014
Primary Outcome: Primary Efficacy
Secondary Outcome: Secondary Efficacy
Study sponsors, principal investigator, and references
Principal Investigator: Rajiv Saran, MD, MS, MRCP
Lead Sponsor: University of Michigan
Collaborator: Forest Laboratories