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

Acute Kidney Injury Clinical Trial

— NIRVANA  

Official title:

NIRVANA: NIcotinamide Riboside in SARS-CoV-2 pAtients for reNAl Protection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04818216
• Other study ID #: HSC20200914H
• Secondary ID: 3UH3DK114920-04S
• Status: Completed
• Phase: Phase 2
• Start date: June 11, 2021
• Est. completion date: January 3, 2022

Study information

• Verified date: December 2023
• Source: The University of Texas Health Science Center at San Antonio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: January 3, 2022
• Est. primary completion date: December 9, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• COVID-19
• SARS-CoV-2 Infection

Intervention

Drug:
• Placebo
Placebo capsule containing inert ingredient
• Nicotinamide riboside
250 mg Nicotinamide riboside capsules

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	The University of Texas Health Science Center at San Antonio	San Antonio	Texas
United States	University Health Systems	San Antonio	Texas
United States	Harborview Medical Center	Seattle	Washington

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Whole Blood NAD+ Level	Measure of NAD+ level in whole blood from treatment beginning to end	Baseline to 10 days
Primary	Number of Participants With Adverse Events of Grade 3 or Higher	Safety of NR in hospitalized patients with COVID-19 and AKI (defined as adverse event of Grade 3 or higher). Not every grade 3 event was considered to be serious.	Baseline to 10 days
Primary	Occurrence of Thrombocytopenia	Number occurrences of thrombocytopenia defined as >25% decline in blood platelet count from baseline.	Baseline to 10 days
Secondary	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	Baseline to 10 days
Secondary	Effect of NR on Major Adverse Kidney Events (MAKE)	Number of occurrences of MAKE defined as doubling of serum creatinine, the initiation of long-term dialysis, or death from any cause.	30 days to 90 days
Secondary	Change in Estimated Glomerular Filtration Rate (eGFR)	Measurement of change in eGFR at 30-90 days post randomization	30 days to 90 days
Secondary	Change in Proteinuria	Measurement of change in proteinuria at 30-90 days post randomization	30 days to 90 days