Kidney Week

Abstract: INFO07-TH

Design of a Phase 2 Trial, JUSTICE, Evaluating Baricitinib as Treatment for APOL1-Mediated Kidney Disease

Session Information

• Informational Posters - I
  November 02, 2023 | Location: Exhibit Hall, Pennsylvania Convention Center
  Abstract Time: 10:00 AM - 12:00 PM

Category: Diversity and Equity in Kidney Health

• No subcategory defined

Authors

• Olabisi, Opeyemi A., Duke University, Durham, North Carolina, United States

Opeyemi A. Olabisi,

• Smith, Maurice Walter, Duke University, Durham, North Carolina, United States

Maurice Walter Smith,

• Nystrom, Sarah, Duke University, Durham, North Carolina, United States

Sarah Nystrom,

• Soldano, Karen, Duke University, Durham, North Carolina, United States

Karen Soldano,

• Silas, Daniel Philip, Duke University, Durham, North Carolina, United States

Daniel Philip Silas,

• Datta, Somenath, Duke University, Durham, North Carolina, United States

Somenath Datta,

• Li, Guojie, Duke University, Durham, North Carolina, United States

Guojie Li,

• Lucas, Anika, Duke University, Durham, North Carolina, United States

Anika Lucas,

• Barrett, Nadine J., Duke University, Durham, North Carolina, United States

Nadine J. Barrett,

• Wolf, Myles, Duke University, Durham, North Carolina, United States

Myles Wolf,

Description

In the U.S., APOL1-mediated kidney disease (AMKD) is a major driver of racial inequities in kidney health. African American carriers of high-risk APOL1 genotypes develop focal segmental glomerulosclerosis (FSGS) and hypertension associated kidney disease at higher rates than carriers of low-risk APOL1 genotypes. AMKD progresses to dialysis 10-14 years earlier than CKD due to other causes. Currently, there is no specific treatment for AMKD. Cytokines induce expression of the disease-associated APOL1 variants via the JAK-STAT signaling pathway. Preclinical studies demonstrate that inhibitors of JAK1/2 block cytokine-induced APOL1 expression and APOL1-induced glomerular cell injury. JUSTICE (Janus kinase-STAT Inhibition to Reduce APOL1 Associated Kidney Disease) is a phase 2, double-blind, randomized, placebo-controlled study of baricitinib, a JAK1/2 inhibitor as a treatment for proteinuric AMKD. Eligibility criteria includes adult (18-70 years old) with high risk APOL1 genotypes and biopsy-proven FSGS or hypertension-associated CKD with albuminuria ≥ 300mg/g and eGFR >25 ml/min/1.73m². Key exclusion criteria include diagnosis of diabetes, HIV, solid organ transplant and prior or current treatment with JAK inhibitor. Eligible study participants are enrolled from all states in the U.S. Percent change in albuminuria from baseline to the 6-month treatment period is the primary endpoint.

Funding

• NIMHD Lilly