Trial of Nicotinamide Riboside and Co-enzyme Q10 in Chronic Kidney Disease

NCT03579693 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: STUDY00004998R01DK101509
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Chronic Kidney Disease; Sarcopenia; Frailty

Keywords

Mitochondria; Antioxidants; CoQ10; Nicotinamide riboside; Ergometry; Fatigue; Aerobic capacity

Outcome Measures

Primary Outcomes (2)

• 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.

  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..

  6 weeks

Study Arms (3)

CoQ10

ACTIVE COMPARATOR

Coenzyme Q10, 2 - 250 mg tablets twice a day (1000 mg total daily dose) for 6 weeks

Dietary Supplement: CoQ10

Nicotinamide riboside

ACTIVE COMPARATOR

Nicotinamide riboside, 1 - 600 mg tablet twice a day (1200 mg total daily dose) for 6 weeks

Dietary Supplement: Nicotinamide riboside

Placebo

PLACEBO COMPARATOR

Placebo, inactive sugar pill for 6 weeks

Dietary Supplement: Placebo

Interventions

CoQ10 DIETARY_SUPPLEMENT

CoQ10 tablet

Also known as: coenzyme Q10

CoQ10

Nicotinamide riboside DIETARY_SUPPLEMENT

NR tablet

Also known as: NR

Nicotinamide riboside

Placebo DIETARY_SUPPLEMENT

Sugar pill designed to mimic coQ10 and NR

Placebo

Eligibility Criteria

• Age: 30 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• University of Washington: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Washington

Seattle, Washington, 98104, United States

Location

Related Publications (2)

• 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.

  PMID: 39847432 DERIVED

• Ahmadi 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.

  PMID: 37159264 DERIVED

Related Links

• Website for the Kidney Research Institute at the University of Washington

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Sarcopenia; Frailty; Fatigue

Interventions

coenzyme Q10; nicotinamide-beta-riboside

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms

Results Point of Contact

• Title: Bryan Kestenbaum, MD
• Organization: University of Washington

brk@uw.edu

206-685-7343

Study Officials

• Bryan Kestenbaum, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

• Baback Roshanravan, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, School of Medicine: Department of Medicine: Nephrology

Model Details: Randomized, placebo-controlled, cross-over trial

Study Record Dates

• First Submitted: June 25, 2018
• First Posted: July 6, 2018
• Study Start: November 14, 2018
• Primary Completion: April 26, 2021
• Study Completion: April 26, 2021
• Last Updated: January 10, 2023
• Results First Posted: January 10, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)