Status:
RECRUITING
Nicotinamide Riboside Supplementation for Treating Arterial Stiffness and Elevated Systolic Blood Pressure in Patients With Moderate to Severe CKD
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Vascular Diseases
Kidney Disease
Eligibility:
All Genders
35-80 years
Phase:
PHASE2
Brief Summary
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. ...
Detailed Description
Background: Risk of cardiovascular diseases (CVD) is significantly elevated in patients with chronic kidney disease (CKD). Arterial dysfunction is an important nontraditional CV risk factor gaining in...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 19 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 15 2024
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT04040959
Start Date
November 19 2019
End Date
September 15 2024
Last Update
April 10 2024
Active Locations (1)
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1
UColorado
Aurora, Colorado, United States, 80045