Clinical Trials

In order to improve healthcare for Veterans, we engage in a series of clinical trials, aimed at helping us identify problem areas, find solutions and improve the system.

Current BRINM Clinical Trials

PROMINENT Pemafibrate to Reduce cardiovascular OutcoMes by reducing triglycerides IN patiENts with diabetes

P.I.: Michelle Ratliffe, MD

Synopsis– This is a research study to find out if K-877 (also called pemafibrate), the study drug, compared to placebo (a treatment which looks like the medicine but contains no active pemafibrate), lowers cardiovascular (CV) complications (also referred to as “events”), such as heart attack, stroke, and death from these conditions, in adults with type-2 diabetes mellitus (T2D) who have elevated triglycerides (TGs; one type of fat), and low high-density lipoprotein cholesterol (HDL-C; “good” cholesterol).

Influenza Vaccine to Effectively Stop Cardio Thoracic Events and Decompensated heart failure (INVESTED)

P.I.: Michelle Ratliffe, MD

Synopsis– The purpose of this study is to see if a high-dose influenza (“flu”) vaccine is able to safely reduce heart or lung-related problems compared to the standard-dose flu vaccine. Both the high dose and standard dose flu vaccines called Fluzone® are manufactured by Sanofi Pasteur.

International Study of Comparative Health Effectiveness with Medical and Invasive Approaches- Chronic Kidney Disease (ISCHEMIA-CKD).

P.I.: Michelle Ratliffe, MD

Synopsis– Comparing two standard treatment options for people with advanced chronic kidney disease that have narrowed heart arteries due to the buildup of cholesterol to determine which one is the better and safer choice.

Phase 3, Randomized, Open-Label, Active-Controlled Study Evaluating the Efficacy and Safety of Oral Vadadustat for the Correction of Anemia in Subjects with Non-Dialysis-Dependent Chronic Kidney Disease.

P.I.: Karen S. Servilla, MD, FACP

Synopsis – Testing the new medication, vadadustat to determine if it is an effective treatment for anemia (low red blood cell count) in patients with chronic (long-term)kidney disease.

A Phase II, Multicenter, Randomized, Open-label Study to Investigate the Safety and Efficacy of Pegfilgrastim (Neulasta®) in Patients with Alcoholic Hepatitis.

P.I.: Joseph Alcorn, MD

Synopsis– Studying new treatments for alcoholic hepatitis (AH) and investigating the pathophysiology (functional changes) of alcoholic hepatitis (liver inflammation caused by drinking alcohol). The primary purpose of this study is to determine whether treatment with pegfilgrastim (Neulasta®) in addition to prednisolone or pentoxifylline is more effective than treatment with prednisolone or pentoxifylline alone 06 in patients with AH.

Phase 3, Randomized, Open-Label, Active-Controlled Study Evaluating the Efficacy and Safety of Oral Vadadustat for the Maintenance Treatment of Anemia in Subjects with Non-Dialysis-Dependent Chronic Kidney Disease

P.I.: Karen S. Servilla, MD, FACP

Synopsis – Testing the new medication, vadadustat to determine if it is an effective maintenance treatment for anemia (low red blood cell count) in patients with chronic (long-term) kidney disease.