Summary

Eligibility
for people ages 30 years and up (full criteria)
Location
at UCSD
Dates
study started
study ends around
Principal Investigator
by Armin Ahmadi, PhD (ucsd)
Headshot of Armin Ahmadi
Armin Ahmadi

Description

Summary

This study is testing whether a dietary supplement called nicotinamide riboside, (NR), can be used in adults with moderate chronic kidney disease. NR is a form of vitamin B3 that may help support cellular energy metabolism.

The main goal of this study is to see whether it is feasible for people with chronic kidney disease to take NR daily, complete study visits, and follow the study procedures. The study will also explore whether NR chloride affects markers of mitochondrial health, small blood vessel function, and physical function.

Participants will be randomly assigned to one of two treatment orders. One group will take NR first and placebo second. The other group will take placebo first and NR second. Placebo looks like NR but does not contain active NR. Each treatment period lasts 12 weeks, with an approximately 2-week washout period between treatments. Neither participants nor the study team will know which treatment participants are taking during each period.

Study visits will include blood and urine collection, physical function testing, and noninvasive tests of small blood vessel function. The study will enroll up to 36 adults with moderate chronic kidney disease at the University of California, San Diego.

Official Title

Pilot Randomized Crossover Trial of Nicotinamide Riboside in Chronic Kidney Disease (NR-CKD Trial)

Details

Chronic kidney disease is associated with impaired mitochondrial function, vascular dysfunction, reduced physical function, and increased risk of cardiovascular and functional decline. Nicotinamide riboside is a vitamin B3 derivative and NAD+ precursor that may support cellular energy metabolism and vascular health.

This pilot study will evaluate the feasibility of using nicotinamide riboside in adults with moderate chronic kidney disease. The study uses a randomized, double-blind, placebo-controlled crossover design so that each participant receives both nicotinamide riboside chloride and placebo during separate treatment periods.

In addition to feasibility measures, the study will collect exploratory data on mitochondrial, microvascular, and physical function outcomes. These data will help determine whether a larger clinical trial of nicotinamide riboside in chronic kidney disease is practical and scientifically justified.

Keywords

Chronic Kidney Disease, Nicotinamide riboside, Microvascular function, Physical function, Cell-free mitochondrial DNA, Chronic Renal Insufficiency, nicotinamide-beta-riboside, Capsules, Nicotinamide Riboside (NR)

Eligibility

You can join if…

Open to people ages 30 years and up

  • Moderate chronic kidney disease not treated with dialysis, defined as eGFR 30-59 mL/min/1.73 m2 using the CKD-EPI equation.
  • Urine albumin-to-creatinine ratio (uACR) <300 mg/g.
  • Able to provide informed consent.
  • Able to walk unassisted from room to room, with usual assistive device allowed if approved by study safety assessment.
  • Willing and able to comply with study procedures, visits, and study product administration.

You CAN'T join if...

  • Pregnancy.
  • Expectation to start dialysis within 6 months.
  • Unable to walk unassisted from room to room.
  • Institutionalization or inability to consent.
  • End-stage liver disease with cirrhosis.
  • HIV.
  • Oxygen-dependent COPD.
  • Baseline systolic blood pressure >170 mmHg or diastolic blood pressure >100 mmHg.
  • Current participation in another interventional trial.
  • Use of immunosuppressive medications, including steroids or calcineurin inhibitors.
  • Malignancy requiring active treatment or currently under surveillance at the discretion of the investigator.
  • Hospitalization for myocardial infarction, unstable angina, cerebrovascular accident, or unstable cardiac chest pain within the prior 3 months.

Location

  • Altman Clinical and Translation Research Institute
    San Diego California 92093 United States

Lead Scientist at University of California Health

  • Armin Ahmadi, PhD (ucsd)
    Postdoctoral Scholar, Medicine, Vc-health Sciences-schools. Authored (or co-authored) 36 research publications

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
ID
NCT07693543
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 30 study participants
Last Updated