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NIRVANA: Nicotinamide Riboside in SARS-CoV-2 (COVID-19) Patients for Renal Protection

Sponsor
The University of Texas Health Science Center at San Antonio (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04818216
Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)
32
Enrollment
4
Locations
2
Arms
16.7
Anticipated Duration (Months)
8
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

An interventional clinical trial using oral nicotinamide riboside (NR) in hospitalized patients with COVID-19 infection and acute kidney injury to determine the effect of NR on whole blood nicotinamide adenine dinucleotide (NAD+) levels and to evaluate safety of the use of NR.

Condition or Disease Intervention/Treatment Phase
  • Drug: Placebo
  • Drug: Nicotinamide riboside
 Phase 2

Detailed Description

The study team chose a treatment protocol with NR as a treatment for patients who will be admitted with COVID-19 related illness and develop AKI after admission. Treatment duration will be for 10 days and the primary study endpoint will be the change in whole blood NAD+ from baseline to end of treatment in NR group vs placebo group. The study team will evaluate whole blood NAD+ levels as a marker of efficacy and biological effect of NR.

Study Design

Study Type:
Interventional
Actual Enrollment :
32 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Prospective, double-blind, placebo-controlled clinical interventional trialProspective, double-blind, placebo-controlled clinical interventional trial
Masking:
Double (Participant, Investigator)
Masking Description:
The study drug (NR or placebo) packaging and labeling will be designed to maintain the blinding of the investigator's team and the participants.
Primary Purpose:
Treatment
Official Title:
NIRVANA: NIcotinamide Riboside in SARS-CoV-2 pAtients for reNAl Protection
Actual Study Start Date :
Jun 11, 2021
Actual Primary Completion Date :
Nov 1, 2021
Anticipated Study Completion Date :
Nov 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Placebo Group

Placebo capsules will be administered 2 capsules twice daily for 10 days

Drug: Placebo
Placebo capsule containing inert ingredient
Other Names:
  • Microcrystalline cellulose

    		•
    Experimental: Nicotinamide Riboside Group

    Nicotinamide riboside 250mg capsules will be administered 2 capsules twice daily for 10 days

    Drug: Nicotinamide riboside
    250 mg Nicotinamide riboside capsules
    Other Names:
  • Niagen

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in whole blood NAD+ level [Baseline to 10 days]

      Measure of NAD+ level in whole blood from treatment beginning to end

    2. Number of Adverse Events of Grade 3 or Higher [Baseline to 10 days]

      Safety of NR in hospitalized patients with COVID-19 and AKI (defined as the occurrence of at least one serious adverse event of grade 3 or higher)

    3. Occurrence of Thrombocytopenia [Baseline to 10 days]

      Number occurrences of thrombocytopenia defined as >25% decline in blood platelet count from baseline.

    Secondary Outcome Measures

    1. Change in Area under the curve (AUC) [Baseline to 10 days]

      To determine the effect of NR on changes in AUC serum creatinine from baseline during the 10-day intervention

    2. Effect of NR on Major Adverse Kidney Events (MAKE) [30 days to 90 days]

      Time to first occurrence of MAKE defined as doubling of serum creatinine, the initiation of long-term dialysis, or death from any cause

    3. Change in estimated Glomerular Filtration Rate (eGFR) [30 days to 90 days]

      Measurement of change in eGFR at 30-90 days post randomization

    4. Change in Proteinuria [30 days to 90 days]

      Measurement of change in proteinuria at 30-90 days post randomization

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Provision of signed and dated informed consent form from a participant or legally authorized representative (LAR);

    2. Male or female, >18 years old;

    3. Hospitalized participants with a laboratory diagnosis of COVID-19 infection

    4. Evidence of persistent AKI as defined by the Kidney Disease: Improving Global Outcomes (KDIGO) guidelines (Table 3);

    5. Willing to adhere to the study intervention regimen;

    Exclusion Criteria:

    1. Hypersensitivity to nicotinamide riboside (NR);

    2. Pregnant or lactating women confirmed with positive laboratory pregnancy tests as per local requirements;

    3. eGFR <15 mL/min/1.73 m2 as per the Chronic Kidney Disease Epidemiology Collaboration equation at admission lab;

    4. Maintenance renal replacement therapy or initiation of renal replacement therapy before randomization

    5. Currently on NR or nicotinamide or vitamin B3 (niacin) supplementation (multivitamins are allowed);

    6. Concomitant cirrhosis of liver or acute liver failure;

    7. Any medical history or condition that might, in the opinion of the attending physician, put the participant at significant risk if he/she were to participate in the trial;

    8. Individuals with kidney transplant;

    9. Individuals with blood platelet count <100,000/microL

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Icahn School of Medicine at Mount Sinai New York New York United States 10029-6574
    2 The University of Texas Health Science Center at San Antonio San Antonio Texas United States 78229
    3 University Health Systems San Antonio Texas United States 78229
    4 Harborview Medical Center Seattle Washington United States 98104

    Sponsors and Collaborators

    • The University of Texas Health Science Center at San Antonio
    • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    Investigators

    • Principal Investigator: Kumar Sharma, MD, UT Health San Antonio

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Kumar Sharma, Holder of the L. David Hillis, M.D. Endowed Chair, Medicine -Renal Diseases, The University of Texas Health Science Center at San Antonio
    ClinicalTrials.gov Identifier:
    NCT04818216
    Other Study ID Numbers:
    • HSC20200914H
    • 3UH3DK114920-04S2
    First Posted:
    Mar 26, 2021
    Last Update Posted:
    Apr 4, 2022
    Last Verified:
    Mar 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    COVID-19
    Acute Kidney Injury
    Niacinamide
    Niacin
    Nicotinic Acids

    Study Results

    No Results Posted as of Apr 4, 2022