Valproic Acid (VPA) for Acute Kidney Injury (AKI) in Liver Transplant Patients

• Status: Withdrawn
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to find out if a drug called valproic acid (VPA) will protect organs (like the kidneys) from harmful effects caused by the temporary drop and then rise of blood flow and oxygen (called ischemia reperfusion (I/R) injury that sometimes happens during liver transplant surgery. VPA is an approved drug for treating conditions such as seizures and migraines for many years. However, it is not approved for use at the higher dose that will be used in this study or for protecting organs from I/R injury. This study will enroll liver transplant patients and randomly assign them to receive either VPA diluted in salt water or salt water without VPA (placebo) and then follow the patients and compare their organ function and overall outcome. This study is masked meaning that the patients, doctors, and nurses will not know which patient received which treatment. The study treatment will be given in addition to the care that liver transplant patients normally receive. The researchers doing this study believe that VPA will lessen organ injury caused by I/R, meaning that patients who receive VPA will experience less kidney injury when compared to patients who receive the placebo.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Westat
• Collaborators: Clinipace Worldwide; United States Department of Defense
• Treatments: Valproic Acid

Criteria

Inclusion Criteria:

• Is aged 18 to 80 years old;

• Is male or non-pregnant, non-breastfeeding female;

• Is able to provide written informed consent or has an LAR from whom consent can be obtained;

• Body mass index (BMI) is between 18 kg/m2 and 35 kg/m2;

• Expected transfusion of 3 or more units of red cell product, as determined by the patient's provider; and

• Is scheduled to undergo liver transplant surgery without hepatocellular carcinoma (HCC) exception points.

Exclusion Criteria:

• Has a known history of adverse reaction to VPA;

• Is currently receiving VPA;

• Is pregnant or breastfeeding;

• Is in need of a simultaneous kidney transplant, or currently on RRT for either AKI or hepato-renal syndrome, type I (HRS-I);

• Is currently incarcerated or pending incarceration;

• Is known to have mitochondrial disorders caused by polymerase γ (POLG) mutations;

• Has acute liver failure;

• Has porto-pulmonary hypertension;

• Has hepato-pulmonary syndrome;

• Transplant procedure is a veno-venous bypass procedure;

• Is a living-donor transplant or a split liver transplant;

• Is scheduled to undergo liver transplant surgery with HCC exception points; or

• Has other unspecified reason/condition that, in the opinion of the clinical site PI, make the patient unsuitable for enrollment.