A Phase II, Randomized, Double-blinded, Placebo-controlled Clinical Trial to Evaluate the Efficacy of BASIS™ (Nicotinamide Riboside and Pterostilbene) Treatment for Kidney Protection in Patients Treated by Complex Aortic Aneurysm Repair and Aortic Arch Reconstruction
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- AKI
研究概览
简要总结
This study is a single-center, prospective, randomized, double-blinded, placebo-controlled phase II clinical trial to evaluate the efficacy of "NAD+ supplementation" with Basis™ (Nicotinamide Riboside and Pterostilbene) in preventing acute kidney injury (AKI) in patients undergoing complex aortic aneurysm repair and open aortic arch reconstruction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A patient may be included in the study if the following conditions are present:
- •Male or female;
- •Age > 18 years old;
- •Patients who match the criteria for indication of elective open aortic arch replacement or repair:
- •Total arch;
- •Non-total arch;
- •Patients who match the criteria for indication of elective complex aortic aneurysm repair has to respect the following conditions:
- •a. Patients undergoing complex aortic aneurysm open reconstruction with a suprarenal clamp; i. thoracoabdominal aortic aneurysms Crawford extent I to IV ; ii. abdominal aortic aneurysms of juxtarenal, pararenal, or paravisceral type; b. For endovascular approach: i. patients with pararenal or thoracoabdominal aortic aneurysms Crawford extent I to IV and known stage III or IV of chronic kidney disease (CKD); ii. patients with pararenal or thoracoabdominal aortic aneurysms Crawford extent I to IV and solitary or single functioning kidney and known stage III or IV CKD;
- •Patients will be allowed to participate in concomitant endovascular aortic stent-graft trials and prospective cohort studies as long as these do not involve another investigational study drug.
排除标准
- •Patients must be excluded from the study if any of the following conditions are true:
- •5.2.1 General Exclusion Criteria
- •Unwilling to comply with the follow-up schedule;
- •Inability or refusal to give informed consent by the patient or a legally authorized representative;
- •Pregnant or breastfeeding;
- •Subject who takes multivitamins containing vitamin B3 derivatives in a dose > 200 mg/day; 5.2.2 Clinical / Laboratory Exclusion Criteria
- •Renal failure defined as eGFR< 15 mL/min/1.73m2
- •Patients in permanent Renal Replacement Therapy;
- •Patients with chronic liver disease: Child-Pugh score class B and C; 5.2.3 Medication Exclusion Criteria
- •Patients in chemotherapy scheme;
- •Patients taking any immunosuppressant, except for corticosteroids;
- •Patients taking any of these well-known P-glycoprotein substrates: digoxin, fexofenadine, indinavir, sirolimus.
研究组 & 干预措施
Basis
The investigational product, Basis™, contains a synthetic NR that is nature-identical to naturally-occurring NR, does not induce flushing or pruritus and has no effect on lipid levels. Also contains Pterostilbene (Ptero) that is a stilbenoid compound, characterized by two aromatic rings connected by a methylene bridge backbone, and it has two methoxy groups and one hydroxyl group extending from the aromatic rings.
干预措施: Nicotinamide Riboside + Pterostilbene (Drug)
Placebo
Correspondent placebo, a capsule not containing the active component.
干预措施: Placebo (Drug)
结局指标
主要结局
AKI
时间窗: 6 months
The primary endpoint will be change in incidence of AKI measured by estimated glomerular filtration rate (eGFR) using the RIFLE criteria.
次要结局
- Bowel ischemia(6 months)
- Spinal cord injury(6 months)
- Myocardial infarction(6 months)
- Nicotinamide Adenine Dinucleotide (NAD), Nicotinamide Mononucleotide (NMN), and Nicotinamide Riboside (NR)(6 months)
- Tissue Inhibitor of Metalloproteinases 2 (TIMP2), Kidney Injury Molecule 1 (KIM-1), Insulin-like Growth Factor-binding Protein 7 (IGFBP7)(6 months)
- Quinolinate and Tryptophan(6 months)
研究者
Bernardo C. Mendes
Principal Investigator
Mayo Clinic