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

Primary Purpose

SARS-CoV-2 Infection, Acute Kidney Injury

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Placebo
Nicotinamide riboside
Sponsored by
The University of Texas Health Science Center at San Antonio
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for SARS-CoV-2 Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Icahn School of Medicine at Mount Sinai
  • The University of Texas Health Science Center at San Antonio
  • University Health Systems
  • Harborview Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo Group

Nicotinamide Riboside Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in whole blood NAD+ level
Measure of NAD+ level in whole blood from treatment beginning to end
Number of Adverse Events of Grade 3 or Higher
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)
Occurrence of Thrombocytopenia
Number occurrences of thrombocytopenia defined as >25% decline in blood platelet count from baseline.

Secondary Outcome Measures

Change in Area under the curve (AUC)
To determine the effect of NR on changes in AUC serum creatinine from baseline during the 10-day intervention
Effect of NR on Major Adverse Kidney Events (MAKE)
Time to first occurrence of MAKE defined as doubling of serum creatinine, the initiation of long-term dialysis, or death from any cause
Change in estimated Glomerular Filtration Rate (eGFR)
Measurement of change in eGFR at 30-90 days post randomization
Change in Proteinuria
Measurement of change in proteinuria at 30-90 days post randomization

Full Information

First Posted
March 24, 2021
Last Updated
August 23, 2023
Sponsor
The University of Texas Health Science Center at San Antonio
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT04818216
Brief Title
Nicotinamide Riboside in SARS-CoV-2 (COVID-19) Patients for Renal Protection
Acronym
NIRVANA
Official Title
NIRVANA: NIcotinamide Riboside in SARS-CoV-2 pAtients for reNAl Protection
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
June 11, 2021 (Actual)
Primary Completion Date
December 9, 2021 (Actual)
Study Completion Date
January 3, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center at San Antonio
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SARS-CoV-2 Infection, Acute Kidney Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Prospective, double-blind, placebo-controlled clinical interventional trial
Masking
ParticipantInvestigator
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.
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
Placebo capsules will be administered 2 capsules twice daily for 10 days
Arm Title
Nicotinamide Riboside Group
Arm Type
Experimental
Arm Description
Nicotinamide riboside 250mg capsules will be administered 2 capsules twice daily for 10 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Microcrystalline cellulose
Intervention Description
Placebo capsule containing inert ingredient
Intervention Type
Drug
Intervention Name(s)
Nicotinamide riboside
Other Intervention Name(s)
Niagen
Intervention Description
250 mg Nicotinamide riboside capsules
Primary Outcome Measure Information:
Title
Change in whole blood NAD+ level
Description
Measure of NAD+ level in whole blood from treatment beginning to end
Time Frame
Baseline to 10 days
Title
Number of Adverse Events of Grade 3 or Higher
Description
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)
Time Frame
Baseline to 10 days
Title
Occurrence of Thrombocytopenia
Description
Number occurrences of thrombocytopenia defined as >25% decline in blood platelet count from baseline.
Time Frame
Baseline to 10 days
Secondary Outcome Measure Information:
Title
Change in Area under the curve (AUC)
Description
To determine the effect of NR on changes in AUC serum creatinine from baseline during the 10-day intervention
Time Frame
Baseline to 10 days
Title
Effect of NR on Major Adverse Kidney Events (MAKE)
Description
Time to first occurrence of MAKE defined as doubling of serum creatinine, the initiation of long-term dialysis, or death from any cause
Time Frame
30 days to 90 days
Title
Change in estimated Glomerular Filtration Rate (eGFR)
Description
Measurement of change in eGFR at 30-90 days post randomization
Time Frame
30 days to 90 days
Title
Change in Proteinuria
Description
Measurement of change in proteinuria at 30-90 days post randomization
Time Frame
30 days to 90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Provision of signed and dated informed consent form from a participant or legally authorized representative (LAR); Male or female, >18 years old; Hospitalized participants with a laboratory diagnosis of COVID-19 infection Evidence of persistent AKI as defined by the Kidney Disease: Improving Global Outcomes (KDIGO) guidelines (Table 3); Willing to adhere to the study intervention regimen; Exclusion Criteria: Hypersensitivity to nicotinamide riboside (NR); Pregnant or lactating women confirmed with positive laboratory pregnancy tests as per local requirements; eGFR <15 mL/min/1.73 m2 as per the Chronic Kidney Disease Epidemiology Collaboration equation at admission lab; Maintenance renal replacement therapy or initiation of renal replacement therapy before randomization Currently on NR or nicotinamide or vitamin B3 (niacin) supplementation (multivitamins are allowed); Concomitant cirrhosis of liver or acute liver failure; 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; Individuals with kidney transplant; Individuals with blood platelet count <100,000/microL
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kumar Sharma, MD
Organizational Affiliation
UT Health San Antonio
Official's Role
Principal Investigator
Facility Information:
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029-6574
Country
United States
Facility Name
The University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
University Health Systems
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All collected IPD, all IPD that underlie results in a publication
IPD Sharing Time Frame
At the time when summary data are published or otherwise made available

Learn more about this trial

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

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