Nicotinamide riboside for treating arterial stiffness and high blood pressure in chronic kidney disease patients

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

This study is testing if taking nicotinamide riboside can help people with chronic kidney disease lower their blood pressure and improve the stiffness of their arteries.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 118 (estimated)
• Ages: 35 Years to 80 Years
• Sex: All
• Sponsor: University of Colorado, Denver (Academic / other)
• Drugs / interventions: infliximab, adalimumab
• Locations: 1 site (Aurora, Colorado)
• Trial ID: NCT04040959 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of nicotinamide riboside supplementation on arterial stiffness and elevated systolic blood pressure in patients with moderate to severe chronic kidney disease (CKD). The study aims to explore how this compound, a precursor of NAD+, can mimic the benefits of caloric restriction, which is known to improve cardiovascular health but is difficult for patients to maintain. Participants will be randomly assigned to receive either the supplement or a placebo, and their arterial stiffness will be measured using carotid-femoral pulse wave velocity. The trial is designed to assess the safety and efficacy of this intervention over a specified period.

Who should consider this trial

Good fit: Ideal candidates are adults aged 35-80 with stage III or IV CKD and controlled blood pressure.

Not a fit: Patients requiring chronic dialysis or with severe comorbid conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce cardiovascular risks associated with chronic kidney disease.

How similar studies have performed: Previous studies have shown promising results with nicotinamide riboside in healthy adults, suggesting potential for success in this population.

Eligibility criteria

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.

Where this trial is running

Aurora, Colorado

• UColorado — Aurora, Colorado, United States (Recruiting)

Study contacts

• Principal investigator: Michel Chonchol, MD — University of Colorado, Denver
• Study coordinator: Michel Chonchol, MD

Conditions Vascular Diseases; Kidney Disease; Blood Pressure; Oxidative Stress; stiffness; chronic kidney disease; Hypertension