Pharmacokinetics, Pharmacodynamics and Safety of Basis in Acute Kidney Injury Study (BAKIS)
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|ClinicalTrials.gov Identifier: NCT03176628|
Recruitment Status : Completed
First Posted : June 5, 2017
Last Update Posted : June 27, 2019
|Condition or disease||Intervention/treatment||Phase|
|Acute Kidney Injury||Dietary Supplement: Basis Dietary Supplement: Placebo||Not Applicable|
Acute kidney injury (AKI) is common, growing in incidence, and associated with significant morbidity and mortality. 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.
This is a randomized, double-blind, placebo-controlled, stepwise study of escalating doses of Basis (NR/pterostilbene) in patients with AKI. The study will potentially comprise up to four Steps. The purpose of the stepwise approach is to identify the dose of Basis that achieves at least a 50% and up to 100% increase in white blood cell (WBC) content of nicotinamide adenine dinucleotide (NAD+) without side-effects.
During each Step, Basis (5 patients) or placebo (1 patient) will be given twice a day for 2 days. Patients will have frequent blood sampling performed for a 24 hour period following dosing on Day 1 and then at 48 hr. The measurements in blood will include NR/pterostilbene blood concentrations and NAD+ and NAAD (nicotinic acid adenine dinucleotide) concentrations in WBCs.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized 5 subjects in active arm (Basis) : 1 subject in control (placebo)|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Masking Description:||Placebo capsules are identical in appearance to active agent.|
|Official Title:||Randomized, Double-blind, Placebo-controlled, Stepwise Study of the Pharmacokinetics, Pharmacodynamics & Safety of Escalating Doses of Basis (Nicotinamide Riboside and Pterostilbene) in Patients With Acute Kidney Injury (AKI)|
|Actual Study Start Date :||November 1, 2017|
|Actual Primary Completion Date :||September 11, 2018|
|Actual Study Completion Date :||September 11, 2018|
Nicotinamide riboside (NR) and pterostilbene oral capsules 250mg/50mg (Step 1) twice daily for 2 days. If the study progresses to Steps 2, 3, and 4, then 2x, 3x, and 4x the doses in Step 1 will be administered.
Dietary Supplement: Basis
NR is a form of vitamin B3; Pterostilbene is a natural dietary compound and the primary antioxidant component of blueberries
Other Name: nicotinamide riboside (NR) and pterostilbene
Placebo Comparator: Placebo
Capsules identical in appearance and number to the agent used in Steps 1-4.
Dietary Supplement: Placebo
- Maximum plasma concentration [Cmax] of NR [ Time Frame: 2 days ]Maximum plasma concentration [Cmax] of NR after oral administration of Basis
- Maximum plasma concentration [Cmax] of pterostilbene [ Time Frame: 2 days ]Maximum plasma concentration [Cmax] of pterostilbene after oral administration of Basis
- Area Under the Curve [AUC] of NR [ Time Frame: 2 days ]Area Under the Curve [AUC] of NR after oral administration of Basis
- Area Under the Curve [AUC] of pterostilbene [ Time Frame: 2 days ]Area Under the Curve [AUC] of pterostilbene after oral administration of Basis
- Incidence of Treatment-Emergent Adverse Events (Safety) [ Time Frame: 2 days ]Subjects will be interviewed to determine onset of nausea, abdominal pain, vomiting, diarrhea, or rash. Adverse events will be characterized as probably related, probably not related, or unknown
- Incidence of Treatment-Emergent Laboratory Abnormalities (Safety) [ Time Frame: 2 days ]comprehensive metabolic panel (including liver function tests), complete blood count
- NAD+ levels [ Time Frame: 2 days ]To determine the increase in NAD+ levels in white blood cells (WBCs) following twice daily Basis administration
- Dose finding for 50% increase in NAD+ levels in WBCs [ Time Frame: 2 days ]Dose of Basis that leads to 50% increase in NAD+ levels in WBC
- Dose finding for 100% increase in NAD+ levels in WBCs [ Time Frame: 2 days ]Dose of Basis that leads to 100% increase in NAD+ levels in WBC
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): NCT03176628
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02118|
|Principal Investigator:||Eugene Rhee, MD||Massachusetts General Hospital|