Phase 2
N=28
Nicotinamide Riboside in SARS-CoV-2 (COVID-19) Patients for Renal Protection
SARS-CoV-2 Infection · Acute Kidney Injury
Bottom Line
View on ClinicalTrials.gov: NCT04818216 ↗Enrolled (actual)
28
Serious AEs
67.9%
Results posted
Dec 2023
Primary outcome: Primary: Change in Whole Blood NAD+ Level — -0.02; 0.06 μg/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Placebo (Drug); Nicotinamide riboside (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The University of Texas Health Science Center at San Antonio
- Primary completion
- Dec 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Whole Blood NAD+ Level |
-0.02; 0.06 | — |
| PRIMARY Number of Participants With Adverse Events of Grade 3 or Higher |
8; 12 | — |
| PRIMARY Occurrence of Thrombocytopenia |
1; 1 | — |
| SECONDARY Change in Area Under the Curve (AUC) |
17.1; 17.9 | — |
| SECONDARY Effect of NR on Major Adverse Kidney Events (MAKE) |
6; 12 | — |
| SECONDARY Change in Estimated Glomerular Filtration Rate (eGFR) |
86.38; 79.02; 112.08; 129.91 | — |
| SECONDARY Change in Proteinuria |
— | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT04818216). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.