NIRVANA clinical study seeks the answer in San Antonio, Seattle and New York.
Researchers at The University of Texas Health Science Center at San Antonio, also referred to as UT Health San Antonio, The University of Washington at Seattle and the Icahn School of Medicine at Mount Sinai in New York have launched NIRVANA, a National Institutes of Health-funded pilot clinical study to treat acute kidney injury (AKI) in COVID-19 patients.
UT Health San Antonio is the coordinating center for the study. The first San Antonio patients have been enrolled at University Hospital, said NIRVANA Principal Investigator and Project Director Kumar Sharma, MD, professor of medicine, director of the Center for Renal Precision Medicine and vice chair of research at UT Health San Antonio.
Vitamin found in diet
The study team is evaluating the effects of a natural treatment called nicotinamide riboside. A form of vitamin B3, nicotinamide riboside is present in small amounts in milk. The randomized study will test the safety of nicotinamide riboside in hospitalized COVID-19 patients and if a biomarker relevant to acute kidney injury will be improved with the study treatment.
“The potential benefit for patients enrolled in this study would be less kidney injury and preservation of kidney function,” Dr. Sharma said. “Our goal is to reduce the severity of acute kidney disease in patients with COVID-19 and potentially other types of acute kidney disease.”
Acute kidney injury, which is reversible, is sudden loss of kidney function. It is also called acute renal failure. Patients with AKI are at higher risk to develop chronic kidney disease, which requires dialysis treatment to filter waste from the blood and may necessitate kidney transplant.
How does the treatment work?
Evidence suggests that nicotinamide riboside and other forms of vitamin B3 can stimulate mitochondrial function in patients with AKI, Dr. Sharma said. Mitochondria are the powerhouses in cells. Our bodies need these power plants to generate energy and operate properly because all organs, especially the brain, heart, and kidney, require ATP, which is the body’s energy currency.
For longer than a decade, Dr. Sharma’s research team has studied mitochondrial dysfunction as a key factor underlying several types of kidney disease, including diabetic kidney disease and obesity-related kidney disease.
“The mitochondrial effect is just being recognized as a problem in COVID-19, and this is one of the first studies, if not the first, to look at improving mitochondrial function in hospitalized COVID-19 patients,” Dr. Sharma said.
The NIRVANA clinical trial is enrolling 60 patients in San Antonio, with the sites in Seattle and New York enrolling another 40, said Subrata Debnath, PhD, co-investigator and lead project coordinator from UT Health San Antonio.
COVID-19 and acute kidney injury
The risk of AKI is greatly increased in COVID-19 patients, according to dozens of studies conducted in China, Europe and the U.S.
“When patients develop AKI with COVID, their mortality is much higher,” Dr. Sharma said. The mortality varies in this patient population and has been reported to be in the range of 35% with rates as high as 75% to 90% in patients requiring kidney replacement therapy. (Reference: https://www.nature.com/articles/s41581-020-00356-5)
NIRVANA is a double-blind, placebo-controlled clinical trial. Patients hospitalized with COVID-19 and AKI will receive either an inactive placebo or the study drug nicotinamide riboside orally twice daily for a total of 10 days.
The Nephrology Division and the Department of Medicine of UT Health San Antonio are playing a significant role with faculty members Mir Tariq Ali, MD; Samin Sharma, MD; and Tareq Nassar, MD, all serving as co-investigators, along with Nick Niazi, MD, second-year nephrology fellow. W. Brian Reeves, MD, professor and chairman of the Department of Medicine, and Thomas Patterson, MD, professor and chief of infectious diseases, are co-clinical investigators on the study, as are Saket Kottewar, MD, MPH, MHA, and Sheena Grant, MD, from the Division of General and Hospital Medicine. University Hospital of University Health in San Antonio is the main participating hospital and is fully supportive of the inpatient study. The Texas Kidney Foundation provides community support. Pavan Bhatraju, MD, MSc, at the University of Washington at Seattle and Steven Coca, DO, MS, at the Icahn School of Medicine at Mount Sinai are site principal investigators at their respective institutions.