Protection From Acute Kidney Injury (AKI) With Basis™ Treatment
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|ClinicalTrials.gov Identifier: NCT04342975|
Recruitment Status : Recruiting
First Posted : April 13, 2020
Last Update Posted : February 23, 2023
|Condition or disease||Intervention/treatment||Phase|
|AKI||Drug: Nicotinamide Riboside + Pterostilbene Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||238 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||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.|
|Masking:||Double (Participant, Investigator)|
|Official Title:||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|
|Actual Study Start Date :||December 1, 2020|
|Estimated Primary Completion Date :||October 2023|
|Estimated Study Completion Date :||October 2023|
Active Comparator: 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.
Drug: Nicotinamide Riboside + Pterostilbene
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.
Other Name: Basis
Placebo Comparator: Placebo
Correspondent placebo, a capsule not containing the active component.
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.
- AKI [ Time Frame: 6 months ]The primary endpoint will be change in incidence of AKI measured by estimated glomerular filtration rate (eGFR) using the RIFLE criteria.
- Myocardial infarction [ Time Frame: 6 months ]The secondary endpoint will be change in the incidence of myocardial infarction
- Bowel ischemia [ Time Frame: 6 months ]The secondary endpoint will be change in the incidence of bowel ischemia
- Spinal cord injury [ Time Frame: 6 months ]The secondary endpoint will be change in the incidence of spinal cord injury
- Nicotinamide Adenine Dinucleotide (NAD), Nicotinamide Mononucleotide (NMN), and Nicotinamide Riboside (NR) [ Time Frame: 6 months ]NAD, NMN, NR levels in peripheral blood mononuclear cells (PBMCs)
- Tissue Inhibitor of Metalloproteinases 2 (TIMP2), Kidney Injury Molecule 1 (KIM-1), Insulin-like Growth Factor-binding Protein 7 (IGFBP7) [ Time Frame: 6 months ]TIMP2, KIM-1, IGFBP7 levels in urine
- Quinolinate and Tryptophan [ Time Frame: 6 months ]Quinolinate and Tryptophan levels in urine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04342975
|Contact: Karina S Kanamori Mendes, MDemail@example.com|
|Contact: Jennifer Haenfirstname.lastname@example.org|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Contact: Karina S Kanamori Mendes, MD|
|Principal Investigator:||Bernardo Mendes, MD||Mayo Clinic|