Valproic Acid (VPA) for Acute Kidney Injury (AKI) in Liver Transplant Patients
Status:
Withdrawn
Trial end date:
2023-06-01
Target enrollment:
Participant gender:
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
Details
Lead Sponsor:
Westat
Collaborators:
Clinipace Worldwide United States Department of Defense