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Baricitinib:
JUSTICE trial

Baricitinib inhibits Janus kinase (JAK) enzymes, which are intracellular enzymes involved in stimulating hematopoiesis and immune cell function through a signaling pathway. It is currently approved for use for adjunctive therapy for alopecia areata and rheumatoid arthritis.

Wavy Abstract Background

Enroll in this clinical study

Maurice Smith

919-613-1386

maurice.w.smith@duke.edu


Opeyemi Olabisi, MD, PhD

919-660-6987

opeyemi.olabisi@duke.edu

How is Baricitinib being studied in APOL1 kidney disease?

Inflammatory cytokines, by activating the Janus kinase-STAT (JAK-STAT) pathway trigger high production of altered APOL1 protein in kidney cells.

Janus kinase-STAT Inhibition to Reduce APOL1 Associated Kidney Disease (JUSTICE) is a single-center, double-blinded, randomized trial of baricitinib therapy for APOL1-associated FSGS or hypertension Associated-CKD.


The goal of this Phase 2 clinical trial is to evaluate the efficacy and safety of Baricitinib to reduce albuminuria in African American/Blacks with APOL1-associated FSGS and APOL1-associated CKD due to hypertension (HTN-CKD). 75 participants will be randomized, participants in the intervention group will take one pill of Baricitinib daily with their regular medications vs one pill of matched placebo pill in the placebo group.

Eligibility Criteria

  1. Self-identified African American/Black

  2. Adults 18-70 years

  3. APOL1 genotype of G1G1, G1G2, or G2G2

  4. FSGS diagnosed by kidney biopsy or clinically diagnosed HTN-CKD

  5. Urine albumin ≥300 mg/g

  6. Estimated glomerular filtration rate (eGFR) ≥30 ml/min/1.73 m2

  7. Able to provide written informed consent

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