Baricitinib for Chronic Kidney Disease

(JUSTICE Trial)

This trial tests a drug called baricitinib (also known as Olumiant) to determine its safety and effectiveness in reducing high levels of protein in the urine, often indicating kidney issues. It specifically targets African American or Black individuals with certain kidney conditions linked to a genetic factor called APOL1. Participants will take either baricitinib or a placebo (a pill with no active drug) alongside their regular medications. Suitable candidates have been diagnosed with kidney problems not caused by diabetes, such as high blood pressure-related kidney disease, and have stable blood pressure treatment. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering participants the opportunity to contribute to significant medical advancements.

The trial requires that you have been on a stable antihypertensive medication regimen for at least 1 month before joining. You cannot participate if you are currently using certain potent immunosuppressants or high-dose corticosteroids. The protocol does not specify other medication restrictions, so it's best to discuss your current medications with the trial team.

Research has shown that baricitinib is generally safe for most people and has been used to treat conditions like diabetic kidney disease. However, it is not recommended for individuals with severe kidney problems, such as those on dialysis or with very low kidney function. The drug may not exit the body quickly in these cases, potentially increasing its effects and side effects.

Unlike the standard treatments for chronic kidney disease, which often include blood pressure medications and blood sugar control, Baricitinib is unique because it targets the Janus kinase (JAK) pathway. This pathway plays a crucial role in inflammation and immune response, offering a novel way to address kidney damage that these traditional treatments may not fully tackle. Researchers are excited about Baricitinib as it could potentially reduce inflammation more effectively, possibly slowing down the progression of kidney disease in a way current options do not.

Research has shown that baricitinib, a medication that blocks certain proteins causing inflammation, may help with kidney problems. In people with diabetic kidney disease, baricitinib reduced the amount of albumin in urine, a sign of kidney issues. This trial will evaluate baricitinib's potential to address similar problems in chronic kidney disease from other causes, such as high blood pressure. Although baricitinib has mainly been studied in diabetes, its mechanism offers hope for broader applications. Additionally, baricitinib has proven effective in treating rheumatoid arthritis, even in individuals with some kidney issues, indicating its potential benefits for kidney health. Participants in this trial will receive either baricitinib or a placebo to assess its effectiveness in chronic kidney disease.³⁶⁷⁸⁹