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

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ClinicalTrials.gov Identifier: NCT04818216
Recruitment Status : Recruiting
First Posted : March 26, 2021
Last Update Posted : August 5, 2021
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Kumar Sharma, The University of Texas Health Science Center at San Antonio

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
SARS-CoV-2 Infection Acute Kidney Injury 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, 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 : June 11, 2021
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Niagen




Primary Outcome Measures :
  1. Change in whole blood NAD+ level [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 30 days to 90 days ]
    Measurement of change in eGFR at 30-90 days post randomization

  4. Change in Proteinuria [ Time Frame: 30 days to 90 days ]
    Measurement of change in proteinuria at 30-90 days post randomization



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04818216


Contacts
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Contact: Kumar Sharma, MD 210 567 4700 sharmak3@uthscsa.edu
Contact: Subrata Debnath, PhD 210 567 4700 nath@uthscsa.edu

Locations
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United States, New York
Icahn School of Medicine at Mount Sinai Not yet recruiting
New York, New York, United States, 10029-6574
United States, Texas
The University of Texas Health Science Center at San Antonio Recruiting
San Antonio, Texas, United States, 78229
Contact: Subrata Debnath, PhD    210-567-4700    nath@uthscsa.edu   
Contact: Kumar Sharma, MD    210 567 4700    sharmak3@uthscsa.edu   
University Health Systems Recruiting
San Antonio, Texas, United States, 78229
Contact: Kumar Sharma, MD    210-567-4700    sharmak3@uthscsa.edu   
Contact: Subrata Debnath, PhD    210-567-4700    nath@uthscsa.edu   
Principal Investigator: Kumar Sharma, MD         
United States, Washington
Harborview Medical Center Recruiting
Seattle, Washington, United States, 98104
Contact: Pavan Bhatraju, MD       bhatraju@uw.edu   
Contact: Linda Manahan       LManahan@Nephrology.washington.edu   
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Kumar Sharma, MD UT Health San Antonio
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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 ( U.S. NIH Grant/Contract )
First Posted: March 26, 2021    Key Record Dates
Last Update Posted: August 5, 2021
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Acute Kidney Injury
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Niacinamide
Niacin
Nicotinic Acids
Vitamin B Complex
Vitamins
Micronutrients
Physiological Effects of Drugs
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents