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

Completed · Not applicable · Has a placebo group

Conditions studied: Acute Kidney Injury

In brief

This study will determine the pharmacokinetics, pharmacodynamics and safety of escalating doses of Basis following twice daily oral administration in patients with acute kidney injury (AKI). Basis is a commercially available nutritional supplement consisting of nicotinamide riboside (NR) and pterostilbene that acts to increase sirtuin activity.

Key facts

Study ID

NCT03176628

Run by

Massachusetts General Hospital

People needed

24

Starts

2017-11-01

Expected to finish

2018-09-11

Last updated by the study team

2019-06-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female hospitalized patients, age ≥ 18 years.
• Patients who have developed AKI (defined by an increase in serum creatinine by ≥0.3 mg/dL within 48 hours; or an increase in serum creatinine to ≥1.5 times baseline, which is known or presumed to have occurred within the prior seven days).
• Adequate hematological and liver function, as assessed by the following laboratory requirements:
• Hemoglobin ≥10.0 g/dL
• 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.
• Able to provide written informed consent in compliance with the Human Investigation Review Committee (IRB).

You may not qualify if…

• 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.
• Unstable or clinically significant concurrent medical condition, psychiatric illness or social situation that would, in the opinion of the investigator, jeopardize the safety of a subject and/or their compliance with the protocol.
• Baseline CKD stage 4-5 (eGFR<30 mL/minute/1.73 m2 as determined using the Modification of Diet in Renal Disease (MDRD) equation; in cases where the MDRD equation may not be suitable, a 24 hour urine creatinine clearance test may be substituted), prior to current hospitalization
• Any malignancy with the exception of cervical carcinoma in situ,nonmelanoma skin cancer, or superficial bladder tumors that have been successfully and curatively treated with no evidence of recurrent or residual disease.

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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