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| Name | Class |
|---|---|
| Elysium Health | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Basis | Active Comparator | 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. |
|
| Placebo | Placebo Comparator | Correspondent placebo, a capsule not containing the active component. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicotinamide Riboside + Pterostilbene | Drug | It will be administered a total of 1000 mg/day of NR and 200 mg/day of Ptero in a regimen of 2 capsules of Basis™ (each capsule 250 mg of NR and 50 mg of Ptero) 2 times a day by mouth for 2 weeks before surgery and 6 weeks after surgery. Each intake has to be apart from each other by, at least, 6 hours of interval. |
| Measure | Description | Time Frame |
|---|---|---|
| AKI | The primary endpoint will be change in incidence of AKI measured by estimated glomerular filtration rate (eGFR) using the RIFLE criteria. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Myocardial infarction | The secondary endpoint will be change in the incidence of myocardial infarction | 6 months |
| Bowel ischemia | The secondary endpoint will be change in the incidence of bowel ischemia |
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Inclusion Criteria:
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:
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.
Exclusion Criteria:
5.2.1 General Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Bernardo Mendes, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 12, 2025 | Mar 28, 2025 | 10 | ||
| Apr 11, 2025 |
| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| C018613 | nicotinamide-beta-riboside |
| C000721168 | Pterocarpus marsupium |
| D000098423 | Radial Basis Function Networks |
| ID | Term |
|---|---|
| D016571 | Neural Networks, Computer |
| D055641 | Mathematical Concepts |
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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.
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|
| Placebo | Drug | The correspondent placebo will be administered in a regimen of 2 capsules 2 times a day by mouth for 2 weeks before surgery and 6 weeks after surgery. Each intake has to be apart from each other by, at least, 6 hours of interval. |
|
| 6 months |
| Spinal cord injury | The secondary endpoint will be change in the incidence of spinal cord injury | 6 months |
| Nicotinamide Adenine Dinucleotide (NAD), Nicotinamide Mononucleotide (NMN), and Nicotinamide Riboside (NR) | NAD, NMN, NR levels in peripheral blood mononuclear cells (PBMCs) | 6 months |
| Tissue Inhibitor of Metalloproteinases 2 (TIMP2), Kidney Injury Molecule 1 (KIM-1), Insulin-like Growth Factor-binding Protein 7 (IGFBP7) | TIMP2, KIM-1, IGFBP7 levels in urine | 6 months |
| Quinolinate and Tryptophan | Quinolinate and Tryptophan levels in urine | 6 months |
| Apr 30, 2025 |
| 11 |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |