NCT07693543

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
24mo left

Started Oct 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 29, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 9, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2026

Expected
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2028

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2028

Last Updated

July 15, 2026

Status Verified

July 1, 2026

Enrollment Period

2 years

First QC Date

June 29, 2026

Last Update Submit

July 13, 2026

Conditions

Keywords

Nicotinamide ribosideChronic kidney diseaseMicrovascular functionPhysical functionCell-free mitochondrial DNA

Outcome Measures

Primary Outcomes (2)

  • Change in plasma cell-free mitochondrial DNA

    Change in plasma cell-free mitochondrial DNA concentration, measured as mitochondrial DNA copies per mL of plasma using droplet digital PCR.

    Baseline, Week 12, and Week 26

  • Change in urine cell-free mitochondrial DNA

    Change in urine cell-free mitochondrial DNA concentration, measured using droplet digital PCR and reported as mitochondrial DNA copies normalized to urine osmolarity.

    Baseline, Week 12, and Week 26

Secondary Outcomes (6)

  • Change in skin fingernail capillary density

    Baseline, Week 12, and Week 26

  • Change in skin blood flow

    Baseline, Week 12, and Week 26

  • Change in six-minute walk distance

    Baseline, Week 12, and Week 26

  • Change in Handgrip Strength

    Baseline, Week 12, and Week 26

  • Change in Timed Up and Go

    Baseline, Week 12, and Week 26

  • +1 more secondary outcomes

Study Arms (2)

Placebo Then NR

EXPERIMENTAL

Participants assigned to this arm will receive matched placebo for 12 weeks, followed by an approximately 14-day washout/crossover period, then nicotinamide riboside 1000 mg/day for 12 weeks.

Dietary Supplement: Matched Placebo (Capsules)

NR Then Placebo

EXPERIMENTAL

Participants assigned to this arm will receive nicotinamide riboside 1000 mg/day for 12 weeks, followed by an approximately 14-day washout/crossover period, then matched placebo for 12 weeks.

Dietary Supplement: Nicotinamide Riboside (NR)

Interventions

Nicotinamide Riboside (NR)DIETARY_SUPPLEMENT

Nicotinamide riboside will be administered orally at a target dose of 1000 mg/day for 12 weeks during the active treatment period.

NR Then Placebo
Matched Placebo (Capsules)DIETARY_SUPPLEMENT

Matched placebo will be administered orally for 12 weeks during the placebo treatment period. The placebo will be identical or substantially similar in appearance to the active nicotinamide riboside study product to maintain blinding.

Placebo Then NR

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 may not qualify 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Altman Clinical and Translation Research Institute

San Diego, California, 92093, United States

Location

Related Publications (3)

  • Trammell SA, Schmidt MS, Weidemann BJ, Redpath P, Jaksch F, Dellinger RW, Li Z, Abel ED, Migaud ME, Brenner C. Nicotinamide riboside is uniquely and orally bioavailable in mice and humans. Nat Commun. 2016 Oct 10;7:12948. doi: 10.1038/ncomms12948.

    PMID: 27721479BACKGROUND
  • Martens CR, Denman BA, Mazzo MR, Armstrong ML, Reisdorph N, McQueen MB, Chonchol M, Seals DR. Chronic nicotinamide riboside supplementation is well-tolerated and elevates NAD+ in healthy middle-aged and older adults. Nat Commun. 2018 Mar 29;9(1):1286. doi: 10.1038/s41467-018-03421-7.

    PMID: 29599478BACKGROUND
  • Conze D, Brenner C, Kruger CL. Safety and Metabolism of Long-term Administration of NIAGEN (Nicotinamide Riboside Chloride) in a Randomized, Double-Blind, Placebo-controlled Clinical Trial of Healthy Overweight Adults. Sci Rep. 2019 Jul 5;9(1):9772. doi: 10.1038/s41598-019-46120-z.

    PMID: 31278280BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

nicotinamide-beta-ribosideCapsules

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dosage FormsPharmaceutical Preparations

Study Officials

  • Armin Ahmadi, PhD

    University of California, San Diego

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Armin Ahmadi, PhD

CONTACT

Rakesh Malhotra, MD, MPH

CONTACT

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Participants will be randomized 1:1 to one of two blinded crossover sequences: NR followed by placebo, or placebo followed by NR. Each treatment period will last 12 weeks, separated by an approximately 14-day washout/crossover period.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 29, 2026

First Posted

July 9, 2026

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

September 30, 2028

Study Completion (Estimated)

September 30, 2028

Last Updated

July 15, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations