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NCT04040959 · ClinicalTrials.gov registry record · Phase 2
Nicotinamide Riboside Supplementation for Treating Arterial Stiffness and Elevated Systolic Blood Pressure in Patients With Moderate to Severe CKD
A Phase 2 study of Blood Pressure and Vascular Diseases, sponsored by University of Colorado, Denver.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 118
- Enrollment target
- 1
- Study location
NCT04040959 is a Phase 2 study of Blood Pressure and Vascular Diseases that is actively recruiting participants, run by University of Colorado, Denver. The registered enrollment target is 118 participants, below the 286-participant average among 101 other Blood Pressure trials with a reported enrollment target (59% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04040959, a Phase 2 study of Blood Pressure and Vascular Diseases, is actively recruiting participants, sponsored by University of Colorado, Denver.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 118 participants
- Enrollment target
- 1
- Study location
Study 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. 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 achieve. Research has shown that boosting NAD+ bioavailability to stimulate SIRT-1, a "CR mimetic" approach, reduces CFPW and oxidative stress in old mice, and this lab recently took the first step in translating these findings in a study of adults with normal kidney function and elevated systolic blood pressure (SBP). The data found that supplementation with nicotinamide riboside, a natural, commercially available precursor of NAD+ and novel CR mimetic, increased NAD+ bioavailability and reduced CFPWV and SBP. A randomized, placebo-controlled, double-blind, single-site phase IIa clinical trial to assess the safety and efficacy of oral nicotinamide riboside (500 mg capsules 2x/day; NIAGEN®; ChromaDex Inc.) for 3 months vs. placebo for decreasing aortic stiffness and SBP in patients (35-80 years) with stage III and IV CKD is being proposed. It is hypothesized that treatment will reduce CFPWV and SBP, as related to increases in systemic NAD+ bioavailability and reductions in oxidative s
Conditions Studied
Interventions
- DRUG Nicotinamide riboside
Study Locations (1)
Colorado
- UColorado - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 118 participants |
| Start Date | 2019-11-19 |
| Est. Completion | 2024-09-15 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04040959
The ClinicalTrials.gov registry entry for NCT04040959 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 118 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 286-participant average among 101 other Blood Pressure trials with a reported enrollment target (59% lower). The listed sponsor is University of Colorado, Denver, which has 1,283 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Blood Pressure appearing as the primary indexed condition, and to 1 intervention - of which Nicotinamide riboside is the first listed.
NCT04040959 reports 1 study location spanning 1 distinct geographic area - top geographies include Colorado.
Frequently Asked Questions
What is clinical trial NCT04040959 about?
NCT04040959 is a clinical study titled "Nicotinamide Riboside Supplementation for Treating Arterial Stiffness and Elevated Systolic Blood Pressure in Patients With Moderate to Severe CKD". 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 ...
What is the current status of trial NCT04040959?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 118 participants. The study started on 2019-11-19. Estimated completion is 2024-09-15.
What conditions does trial NCT04040959 study?
This clinical trial studies the following conditions: Blood Pressure, Vascular Diseases, Oxidative Stress, Kidney Disease.
What interventions are being tested in trial NCT04040959?
The interventions under investigation include: Nicotinamide riboside (DRUG).
Who is sponsoring clinical trial NCT04040959?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04040959 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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