NIRVANA: NIcotinamide Riboside in SARS-CoV-2 pAtients for reNAl Protection
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 4
- 主要终点
- Change in Whole Blood NAD+ Level
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
The study drug (NR or placebo) packaging and labeling will be designed to maintain the blinding of the investigator's team and the participants.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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;
排除标准
- •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
研究组 & 干预措施
Placebo Group
Placebo capsules will be administered 2 capsules twice daily for 10 days
干预措施: Placebo (Drug)
Nicotinamide Riboside Group
Nicotinamide riboside 250mg capsules will be administered 2 capsules twice daily for 10 days
干预措施: Nicotinamide riboside (Drug)
结局指标
主要结局
Change in Whole Blood NAD+ Level
时间窗: Baseline to 10 days
Measure of NAD+ level in whole blood from treatment beginning to end
Number of Participants With Adverse Events of Grade 3 or Higher
时间窗: Baseline to 10 days
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.
Occurrence of Thrombocytopenia
时间窗: Baseline to 10 days
Number occurrences of thrombocytopenia defined as \>25% decline in blood platelet count from baseline.
次要结局
- Change in Estimated Glomerular Filtration Rate (eGFR)(30 days to 90 days)
- Change in Area Under the Curve (AUC)(Baseline to 10 days)
- Effect of NR on Major Adverse Kidney Events (MAKE)(30 days to 90 days)
- Change in Proteinuria(30 days to 90 days)
研究者
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