Pharmacokinetics, Pharmacodynamics and Safety of Basis in Acute Kidney Injury Study

What Was Tested

This registered not phased trial tested NAD+.

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

Capsules identical in appearance and number to the agent used in Steps 1-4.

The registry classes the interventions as dietary supplement.

More on the Plan

Sirtuins are anti-aging enzymes that play a diverse role in cellular energy metabolism and gene regulation.

Mice deficient in SIRT1 are more susceptible to developing AKI and sirtuin activation is a potential treatment for AKI.

The study will potentially comprise up to four Steps.

During each Step, Basis (5 patients) or placebo (1 patient) will be given twice a day for 2 days.

Who Took Part

The registry lists 24 actual participants took part.

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

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Adequate hematological and liver function, as assessed by the following laboratory requirements:. Absolute neutrophil count (ANC) ≥1,500/mm3. Platelet count 100,000/mm3. Total bilirubin ≤1.5 x upper limit of normal (ULN). ALT and AST ≤2.5 x ULN.

The full record lists 9 inclusion and 6 exclusion criteria; among the exclusions: exposure to any investigational agent within 30 days prior to enrollment; known allergy to any of the study drugs or their excipients; currently pregnant (confirmed with a positive serum pregnancy test) or nursing.

How the Study Was Run

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

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

Groups ran in parallel: each of the participants stayed in one arm throughout.

As a double-blind NAD+ study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2017-11-01 with completion listed for 2018-09-11.

It ran at 1 site in United States.

Its stated primary purpose is other.

What Was Measured

Researchers chose this as the main measure: Maximum plasma concentration [Cmax] of NR (time frame: 2 days). Maximum plasma concentration [Cmax] of pterostilbene (time frame: 2 days). Area Under the Curve [AUC] of NR (time frame: 2 days).

It also tracked 3 secondary outcomes, for example NAD+ levels.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of NAD+ in 24 people.

Its size is small, so on its own it can only give an early look.

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

More context: the NAD+ compound page, all human trials.