Interventional Study
a clinical trial in which a new drug or device is used to measure a specific outcome.
CARE and JUSTICE
JUSTICE Clinical Trial Janus kinase-STAT Inhibition to Reduce APOL1 Associated Kidney Disease (JUSTICE)
JUSTICE is a single-center, double-blinded, randomized trial of baricitinib therapy for APOL1-associated FSGS or Hypertension Associated-CKD.
Trial Physician / Study Coordinator
Maurice Smith
Email PhoneSite Name
Duke University
300 North Duke Street, Durham, NC 27701
Interventional Study
a clinical trial in which a new drug or device is used to measure a specific outcome.
CARE and JUSTICE
JUSTICE Clinical Trial Janus kinase-STAT Inhibition to Reduce APOL1 Associated Kidney Disease (JUSTICE)
JUSTICE is a single-center, double-blinded, randomized trial of baricitinib therapy for APOL1-associated FSGS or Hypertension Associated-CKD.
Eligibility Criteria
Patient Population
Focal Segmental Glomerulosclerosis or clinically diagnosed HTN-CKD
Age
18 — 26+
History of transplant allowed?
No
History of dialysis allowed?
No
eGFR
15 — > 60
UPCR
3.0 or Above
Permitted medication history
Ace Inhibitors/ARB, Prednisone (Steroids), Other, None
Patient should be
Treatment Resistant, Neither of These
About the Drug
What is involved for the patient
Participants will be randomized to receive baricitinib or placebo control. Urine and a small blood sample will be collected monthly to monitor kidney function. Participants will be followed for 6 months. Participants will receive compensation each month.
Sponsor
NIAHD
Estimated End Date
2026
About the Trial
Study Drug
Baricitinib
Study Goal
The goal of JUSTICE clinical trial is to determine whether inhibition of APOL1 protein production by baricitinib would slow down progression of APOL1-mediated kidney disease and reduce spillage of protein in the urine.