[logo] HealthTree Foundation
search more_vert
close
person Sign In / Create Account
arrow_back

Go back to trials list

Nicotinamide Riboside Supplementation for Treating Arterial Stiffness and Elevated Systolic Blood Pressure in Patients With Moderate to Severe CKD


Description

Risk of cardiovascular diseases (CVD) is significantly elevated in patients with chronic kidney disease (CKD); however, this increased risk is only partially explained by traditional CV risk factors. Arterial dysfunction is an important nontraditional CV risk factor gaining increased recognition in the field of nephrology. This process is best represented, both physiologically and pathophysiologically, by increases in the gold standard measure of arterial stiffening, carotid to femoral artery pulse wave velocity (CFPWV), which reflects, in particular, increases in aortic stiffness. Aortic stiffening with CKD is mediated by structural and functional (increased vascular smooth muscle tone) changes in the arterial wall stimulated by oxidative stress and chronic low-grade inflammation. Caloric restriction (CR) is a promising strategy for prevention of CKD-associated arterial dysfunction and CVD. However, long-term adherence to chronic CR regimens with optimal nutrition is very difficult to

Trial Eligibility

Inclusion Criteria: * Age 35-80 years; * Ability to provide informed consent; * Willing to accept random assignment to condition; * CKD stage III or IV (eGFR with the 4-variable MDRD prediction equation: 20-60 mL/min/1.73m2; stable renal function in the past 3 months); * Blood pressure controlled to \<140/90 mmHg for the past 3 months; * Body mass index \<40 kg/m2; * Weight stable in the prior 3 months (\<2 kg weight change) and willing to remain weight stable throughout the study Exclusion Criteria: * Patients with advanced CKD requiring chronic dialysis; * Significant co-morbid conditions that lead the investigator to conclude that life expectancy \< 1 year; * History of severe congestive heart failure (i.e., ejection fraction \< 35%); * Hospitalization in the past month; * Proteinuria \> 5 g/day; * Immunosuppressant agents such as cyclosporine, tacrolimus, azathioprine, etanercept, infliximab, adalimumab, anakinra or long-term oral glucocorticoids taken in past 12 months; * Known malignancy; * Woman who are pregnant, nursing or planning to become pregnant; * Special classes of subjects considered vulnerable populations will not be included in the study.

Study Info

Organization

University of Colorado, Denver


Primary Outcome

carotid-femoral pulse wave velocity


Outcome Timeframe Baseline and 3 months

NCTID NCT04040959

Phases PHASE2

Primary Purpose TREATMENT

Start Date 2019-11-19

Completion Date 2024-05-15

Enrollment Target 118

Interventions

DRUG Nicotinamide riboside

Locations Recruiting

UColorado

United States, Colorado, Aurora


Interested in joining this trial?

Our dedicated patient navigators are here to guide you through the validation and enrollment process with ease.

newsletter icon

Get the latest thought leadership on your Kidney Disease delivered straight to your inbox

Subscribe to the weekly newsletter for news, stories, clinical trial updates, and helpful resources and events with cancer experts.