Protection From Acute Kidney Injury (AKI) With Basis™ Treatment

What Was Tested

This registered phase 2 trial tested NAD+ for kidney protection (ckd, diabetic kidney, lupus kidney).

It had two arms (groups): Basis (active comparator) and Placebo (placebo 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.

Correspondent placebo, a capsule not containing the active component.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 54 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: 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:.

The full record lists 8 inclusion and 12 exclusion criteria; among the exclusions: patients must be excluded from the study if any of the following conditions are true:; general exclusion criteria; unwilling to comply with the follow-up schedule;.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

Random assignment meant chance, not the researchers, decided who got NAD+ and who got the comparison, which limits bias.

The NAD+ group and the comparison group ran side by side rather than switching.

Neither the kidney protection (ckd, diabetic kidney, lupus kidney) participants nor the staff measuring them knew who was on NAD+, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2020-12-01 with completion listed for 2024-03-14.

It ran at 1 site in United States.

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): AKI (time frame: 6 months).

It also tracked 6 secondary outcomes, for example Myocardial infarction, Bowel ischemia, Spinal cord injury, Nicotinamide Adenine Dinucleotide (NAD), Nicotinamide Mononucleotide (NMN), and Nicotinamide Riboside (NR), Tissue Inhibitor of Metalloproteinases 2 (TIMP2), Kidney Injury Molecule 1 (KIM-1), Insulin-like Growth Factor-binding Protein 7 (IGFBP7) and Quinolinate and Tryptophan.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of NAD+ in 54 people with kidney protection (ckd, diabetic kidney, lupus kidney).

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the NAD+ compound page, Kidney protection (CKD, diabetic kidney, lupus kidney) research.