Chronic Kidney DiseasePhase 2CoNRNCT03579693
Trial of Nicotinamide Riboside and Co-enzyme Q10 in Chronic Kidney Disease
A Phase 2 study testing CoQ10 and Nicotinamide riboside in people with Chronic Kidney Disease and Sarcopenia, run by University of Washington at 1 site in United States.
Trial summary
Chronic kidney disease is associated with the loss of skeletal muscle mass and function. This process detrimentally impacts mobility, functional independence, and quality of life. Read more about this study
- Who is it for?
- Ages 30 to 79 years
- Conditions the study is for
- Chronic Kidney Disease, Sarcopenia, Frailty
- What is being tested?
- CoQ10 and Nicotinamide riboside
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Nov 2018to 26 Apr 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic kidney disease, defined in this study as an estimated glomerular filtration rate (eGFR) of <50ml/min/1.73m2 using the Chronic Kidney Disease Epidemiology Collaboration equation
Who cannot join
- 6-minute walking distance >500meters
- Pregnancy
- Receiving renal replacement therapy (dialysis or kidney transplantation)
- Expectation to start dialysis within 6 months
- Insulin dependent diabetes mellitus
- Severe anemia: hemoglobin <8 g/dL
Show all 22Show fewer
- Hyperkalemia: K >5.7 mEq/L
- Weight >300 lbs
- HIV
- End stage liver disease with cirrhosis
- Oxygen-dependent Chronic Obstructive Pulmonary Disease (COPD)
- Unable to walk unassisted from room to room in own house
- Institutionalization, or inability to consent
- Use of immunosuppressive medications (i.e. steroids, calcineurin inhibitors)
- Malignancy requiring active treatment or currently under surveillance (at the discretion of the investigator)
- Cardiac pacemaker
- Current participation in another interventional trial
- Non-English speaking
- Hospitalization for heart attack, stroke, or unstable cardiac chest pain within the previous 3 months (e.g. myocardial infarction, unstable angina, cerebrovascular accident)
- Any medical condition that the investigator feels would prevent the participant from safely completing the exercise-based outcome measurements.
- Baseline systolic blood pressure >170 or diastolic blood pressure >100
- Persistent or permanent uncontrolled arrhythmia (at the discretion of the investigator)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cross-over Randomized Controlled Trial of Coenzyme Q10 or Nicotinamide Riboside in Chronic Kidney Disease
Chronic kidney disease is associated with the loss of skeletal muscle mass and function. This process detrimentally impacts mobility, functional independence, and quality of life. Mounting evidence suggests that chronic kidney disease impairs skeletal muscle functioning by injuring mitochondria, the central energy producing units of cells.
Potential treatment options to restore mitochondrial function include aerobic and weight bearing exercise and medications that directly improve mitochondrial energetics. Unfortunately, exercise programs may be difficult to implement in people who have chronic diseases, such as kidney disease.. Coenzyme Q10 (coQ10) and nicotinamide riboside (NR) are naturally occurring supplements that can directly improve mitochondrial efficiency. Both compounds help mitochondria produce more energy while generating less waste.
The primary purpose of this study is to test whether coQ10 and NR can improve muscle function among people with chronic kidney disease. What we learn in this study may help us better understand the mechanisms of skeletal muscle impairment among people with kidney disease and ultimately improve their ability to be active and independent.
Read the detailed description
Sarcopenia (decreased muscle mass or function) is common in patients with chronic kidney disease (CKD) patients with direct impacts on their metabolic and clinical outcomes. Existing evidence and the investigator's preliminary data suggest that mitochondrial dysfunction is a key underlying mechanism of sarcopenia in CKD. However, the ability of treatments to modify mitochondrial functioning in CKD patients is unknown. Coenzyme Q10 (coQ10) and nicotinamide riboside (NR) are naturally occurring supplements that reduce oxidative stress and restore substrate delivery to mitochondria, respectively.
Both processes have the potential to increase mitochondrial energy production with direct consequences for many metabolic and physical processes, including:
- aerobic capacity
- work efficiency
- mitochondrial energetics
- fatigue
- physical function
- inflammation
- oxidative stress
- heart failure symptoms
- metabolomics
These outcomes will assessed in all study participants who enroll in the trial. Addressing these knowledge gaps is necessary to shed new light on the pathophysiology of sarcopenia in CKD and suggest future interventions that reduce morbidity and mortality.
This is a randomized, placebo-controlled, double-blind crossover trial of coQ10 and NR treatments. Participants will receive coQ10 (1000 mg daily), NR (1200 mg daily), or placebo each for six-weeks in random order with a 7-day washout between treatment periods. The primary outcomes are aerobic capacity and muscle work efficiency, measured during cycle ergometry.
- Conditions
- Chronic Kidney Disease, Sarcopenia, Frailty
- Being tested
- CoQ10, Nicotinamide riboside, Placebo
- Keywords
- Mitochondria, Antioxidants, CoQ10, Nicotinamide riboside, Ergometry, Fatigue, Aerobic capacity
- Medical subject headings
- Renal Insufficiency, Chronic, Sarcopenia, Frailty, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoQ10Dietary supplement
Also called coenzyme Q10
CoQ10 tablet
Nicotinamide ribosideDietary supplement
Also called NR
NR tablet
PlaceboDietary supplement
Sugar pill designed to mimic coQ10 and NR
| Study group | Role | What they receive |
|---|---|---|
| CoQ10 | Active comparator | Coenzyme Q10, 2 - 250 mg tablets twice a day (1000 mg total daily dose) for 6 weeks Receives: Dietary Supplement: CoQ10 |
| Nicotinamide riboside | Active comparator | Nicotinamide riboside, 1 - 600 mg tablet twice a day (1200 mg total daily dose) for 6 weeks Receives: Dietary Supplement: Nicotinamide riboside |
| Placebo | Placebo comparator | Placebo, inactive sugar pill for 6 weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal Aerobic Capacity- CoQ10
The maximal aerobic capacity (oxygen uptake mL/min/kg body weight) during cycle ergometry at the end of each treatment period.
Measured: 6 weeks
Work Efficiency
The work efficiency (oxygen uptake mL/min/kg body weight at a specified constant of 60 watts work rate for 3 minutes) during cycle ergometry at the end of each treatment period. This is reported as the work performed at 60 watts divided by the energy expended at 0 watts times 100, and reported on the percent scale..
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2018
- Study start14 Nov 2018
- Primary completion26 Apr 2021
- Study completion26 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, placebo-controlled, cross-over trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bryan Kestenbaum, University of Washington
- Investigators
- Bryan Kestenbaum, MD, Principal investigator, University of WashingtonBaback Roshanravan, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03579693
- Sponsor's protocol ID
- STUDY00004998
- Other IDs
- R01DK101509
- Acronym
- CoNR
- Status last verified
- Dec 2022
- First submitted
- 25 Jun 2018
- Last updated
- 10 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ahmadi A, Valencia AP, Begue G, Norman JE, Fan S, Durbin-Johnson BP, Jenner BN, Campbell MD, Reyes G, Kapahi P, Himmelfarb J, de Boer IH, Marcinek DJ, Kestenbaum BR, Gamboa JL, Roshanravan B. A Pilot Trial of Nicotinamide Riboside and Coenzyme Q10 on Inflammation and Oxidative Stress in CKD. Clin J Am Soc Nephrol. 2025 Mar 1;20(3):346-357. doi: 10.2215/CJN.0000000624. Epub 2025 Jan 23.
PubMed 39847432Ahmadi A, Begue G, Valencia AP, Norman JE, Lidgard B, Bennett BJ, Van Doren MP, Marcinek DJ, Fan S, Prince DK, Gamboa J, Himmelfarb J, de Boer IH, Kestenbaum BR, Roshanravan B. Randomized crossover clinical trial of coenzyme Q10 and nicotinamide riboside in chronic kidney disease. JCI Insight. 2023 Jun 8;8(11):e167274. doi: 10.1172/jci.insight.167274.
PubMed 37159264
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-over Randomized Controlled Trial of Coenzyme Q10 or Nicotinamide Riboside in Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT03579693
- Acronym / sponsor ID
- CoNR / STUDY00004998
- Conditions
- Chronic Kidney Disease, Sarcopenia, Frailty
- Keywords
- Mitochondria, Antioxidants, CoQ10, Nicotinamide riboside, Ergometry, Fatigue, Aerobic capacity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 14 Nov 2018 (actual)
- Primary completion
- 26 Apr 2021 (actual)
- Study completion
- 26 Apr 2021 (actual)
- First posted
- 6 Jul 2018 (actual)
- Results
- Posted 10 Jan 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chronic kidney disease is associated with the loss of skeletal muscle mass and function. This process detrimentally impacts mobility, functional independence, and quality of life. Mounting evidence suggests that chronic kidney disease impairs skeletal muscle functioning by injuring mitochondria, the central energy producing units of cells.
Potential treatment options to restore mitochondrial function include aerobic and weight bearing exercise and medications that directly improve mitochondrial energetics. Unfortunately, exercise programs may be difficult to implement in people who have chronic diseases, such as kidney disease.. Coenzyme Q10 (coQ10) and nicotinamide riboside (NR) are naturally occurring supplements that can directly improve mitochondrial efficiency. Both compounds help mitochondria produce more energy while generating less waste.
The primary purpose of this study is to test whether coQ10 and NR can improve muscle function among people with chronic kidney disease. What we learn in this study may help us better understand the mechanisms of skeletal muscle impairment among people with kidney disease and ultimately improve their ability to be active and independent.
Detailed description
Sarcopenia (decreased muscle mass or function) is common in patients with chronic kidney disease (CKD) patients with direct impacts on their metabolic and clinical outcomes. Existing evidence and the investigator's preliminary data suggest that mitochondrial dysfunction is a key underlying mechanism of sarcopenia in CKD. However, the ability of treatments to modify mitochondrial functioning in CKD patients is unknown. Coenzyme Q10 (coQ10) and nicotinamide riboside (NR) are naturally occurring supplements that reduce oxidative stress and restore substrate delivery to mitochondria, respectively.
Both processes have the potential to increase mitochondrial energy production with direct consequences for many metabolic and physical processes, including:
- aerobic capacity
- work efficiency
- mitochondrial energetics
- fatigue
- physical function
- inflammation
- oxidative stress
- heart failure symptoms
- metabolomics
These outcomes will assessed in all study participants who enroll in the trial. Addressing these knowledge gaps is necessary to shed new light on the pathophysiology of sarcopenia in CKD and suggest future interventions that reduce morbidity and mortality.
This is a randomized, placebo-controlled, double-blind crossover trial of coQ10 and NR treatments. Participants will receive coQ10 (1000 mg daily), NR (1200 mg daily), or placebo each for six-weeks in random order with a 7-day washout between treatment periods. The primary outcomes are aerobic capacity and muscle work efficiency, measured during cycle ergometry.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- Randomized, placebo-controlled, cross-over trial
| Arm | Type | Receives |
|---|---|---|
| CoQ10 | Active comparator | Dietary Supplement: CoQ10Coenzyme Q10, 2 - 250 mg tablets twice a day (1000 mg total daily dose) for 6 weeks |
| Nicotinamide riboside | Active comparator | Dietary Supplement: Nicotinamide ribosideNicotinamide riboside, 1 - 600 mg tablet twice a day (1200 mg total daily dose) for 6 weeks |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo, inactive sugar pill for 6 weeks |
Who may qualify
- Ages
- 30 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Chronic kidney disease, defined in this study as an estimated glomerular filtration rate (eGFR) of <50ml/min/1.73m2 using the Chronic Kidney Disease Epidemiology Collaboration equation
Key exclusion criteria (22 listed)
- 6-minute walking distance >500meters
- Pregnancy
- Receiving renal replacement therapy (dialysis or kidney transplantation)
- Expectation to start dialysis within 6 months
- Insulin dependent diabetes mellitus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CoQ10Also: coenzyme Q10CoQ10 tablet | Dietary supplement | CoQ10 |
| Nicotinamide ribosideAlso: NRNR tablet | Dietary supplement | Nicotinamide riboside |
| PlaceboSugar pill designed to mimic coQ10 and NR | Dietary supplement | Placebo |
Primary outcome
Maximal Aerobic Capacity- CoQ10
Time frame: 6 weeks
The maximal aerobic capacity (oxygen uptake mL/min/kg body weight) during cycle ergometry at the end of each treatment period.
Work Efficiency
Time frame: 6 weeks
The work efficiency (oxygen uptake mL/min/kg body weight at a specified constant of 60 watts work rate for 3 minutes) during cycle ergometry at the end of each treatment period. This is reported as the work performed at 60 watts divided by the energy expended at 0 watts times 100, and reported on the percent scale..
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39847432Ahmadi A, Valencia AP, Begue G, Norman JE, Fan S, Durbin-Johnson BP, Jenner BN, Campbell MD, Reyes G, Kapahi P, Himmelfarb J, de Boer IH, Marcinek DJ, Kestenbaum BR, Gamboa JL, Roshanravan B. A Pilot Trial of Nicotinamide Riboside and Coenzyme Q10 on Inflammation and Oxidative Stress in CKD. Clin J Am Soc Nephrol. 2025 Mar 1;20(3):346-357. doi: 10.2215/CJN.0000000624. Epub 2025 Jan 23.
- Derived from this study: PubMed 37159264Ahmadi A, Begue G, Valencia AP, Norman JE, Lidgard B, Bennett BJ, Van Doren MP, Marcinek DJ, Fan S, Prince DK, Gamboa J, Himmelfarb J, de Boer IH, Kestenbaum BR, Roshanravan B. Randomized crossover clinical trial of coenzyme Q10 and nicotinamide riboside in chronic kidney disease. JCI Insight. 2023 Jun 8;8(11):e167274. doi: 10.1172/jci.insight.167274.
- Website for the Kidney Research Institute at the University of WashingtonLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bryan Kestenbaum, MD principal investigator
University of Washington
Baback Roshanravan, MD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CoQ10 and Nicotinamide riboside in people with Chronic Kidney Disease and Sarcopenia, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal Aerobic Capacity- CoQ10 (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03579693, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2023.