Baricitinib for Chronic Kidney Disease
(JUSTICE Trial)
Trial Summary
Will I have to stop taking my current medications?
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.
What data supports the effectiveness of the drug Baricitinib for chronic kidney disease?
How is the drug Baricitinib different from other treatments for chronic kidney disease?
Baricitinib is unique because it is primarily known as a treatment for rheumatoid arthritis and works by inhibiting Janus kinases (JAKs), which are enzymes involved in inflammation. This mechanism is different from other common treatments for chronic kidney disease, which often focus on controlling blood sugar or blood pressure.678910
What is the purpose of this trial?
This trial is testing if baricitinib can safely reduce high levels of albumin in the urine for African American/Blacks with certain kidney conditions. The drug works by reducing inflammation in the kidneys. Baricitinib has been previously tested for its effectiveness in reducing albumin in adults with Type 2 diabetes who are at high risk for worsening kidney disease.
Research Team
Opeyemi Olabisi, MD
Principal Investigator
Duke University
Eligibility Criteria
This trial is for African American/Black adults aged 18-70 with high-risk APOL1 genotype, diagnosed FSGS or HTN-CKD without diabetes, HIV, sickle cell disease, recent serious infections, previous kidney transplant, certain liver conditions or low blood counts. Participants must have stable blood pressure and not be on potent immunosuppressants.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either Baricitinib or a placebo daily to assess the reduction of albuminuria
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Baricitinib
Baricitinib is already approved in United States, European Union for the following indications:
- Rheumatoid arthritis
- Severe alopecia areata
- COVID-19
- Rheumatoid arthritis
- Severe alopecia areata
- COVID-19
Find a Clinic Near You
Who Is Running the Clinical Trial?
Duke University
Lead Sponsor
National Institute on Minority Health and Health Disparities (NIMHD)
Collaborator
Eli Lilly and Company
Industry Sponsor
Dr. Daniel Skovronsky
Eli Lilly and Company
Chief Medical Officer since 2018
MD from Harvard Medical School
David A. Ricks
Eli Lilly and Company
Chief Executive Officer since 2017
BSc from Purdue University, MBA from Indiana University