Janus Kinase-STAT Inhibition to Reduce APOL1 Associated Kidney Disease (JUSTICE)

The purpose of this study is to determine if the drug, baricitinib, is safe and effective in reducing high levels of albumin in the urine (albuminuria) in African American/Blacks with APOL1- associated focal segmental glomerulosclerosis (FSGS) and non-diabetic APOL1-associated chronic kidney disease due to hypertension (HTN-CKD).

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Diseases
• Intervention / Treatment: Drug: Baricitinib; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke Research at Pickett Road

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults 18-70 years
• High Risk APOL1 genotype (i.e., G1G1, G2G2, or G1G2)
• FSGS diagnosed by kidney biopsy or clinically diagnosed HTN-CKD
• UACR ≥300 mg/dL
• Estimated glomerular filtration rate (eGFR) ≥26 ml/min/1.73 m2 at screening
• Stable antihypertensive regimen for ≥ 1 month prior to enrolment
• Able to provide written informed consent

Exclusion Criteria:

• Diabetes
• HIV
• Sickle cell disease.
• Tip variant of FSGS.
• Systolic BP >180 mmHg or diastolic BP >90 mmHg based on average of 3 measurements.
• Active serious viral, bacterial, fungal or parasitic infection.
• Symptomatic herpes zoster infection within 12 weeks prior to study entry.
• Positive hepatitis B surface antigen during screening (could enroll after treatment).
• Previous kidney transplant.
• History of chronic liver disease with the most recent available aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >1.5 times the ULN or the most recent available total bilirubin ≥1.5 times the ULN
• Hemoglobin <10 g/dL.
• Absolute lymphocyte count (ALC)<500cells/mm3 or absolute neutrophil count (ANC) < 1000 cells/mm3.
• Pregnant or nursing at time of enrollment
• Prior or current treatment with JAK inhibitor.
• Current use of potent immunosuppressants such as abatacept, adalimumab, anakinra, azathioprine, certolizumab, etanercept, golimumab, infliximab, probenecid, rituximab, ruxolitinib, sarilumab, tofacitinib, or tocilizumab.
• High dose corticosteroids (>10 mg per day of prednisone or equivalent) or an unstable dosing regimen of corticosteroids within 2 weeks of study entry or within 6 weeks of planned randomization.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Baricitinib; Participants will take one pill of Baricitinib daily with their regular medications.	Drug: Baricitinib; One pill daily
Placebo Comparator: Placebo; Participants will take a Baricitinib placebo pill matching Baricitinib daily with their regular medications.	Drug: Placebo; Baricitinib placebo pill

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percent change in albuminuria (UACR)	Baseline, monthly for 6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Percent change in eGFR as measured by blood test	Baseline, monthly for 6 months
Percent change in urine CXCL 9-11 as measured by urine test	Baseline, monthly for 6 months
Number of adverse events as measured by patient report	Up to 6 months
Number of adverse events as measured by clinical lab value of hemoglobin less than 9.5g/dL	Up to 6 months

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: Eli Lilly and Company; National Institute on Minority Health and Health Disparities (NIMHD)
• Investigators: Principal Investigator: Opeyemi Olabisi, MD, Duke University

Publications and helpful links

General Publications

• Barrett N, Odera JO, Bethea K, Smith M, Sadeghpour A, Matthews L, Lucas A, Godbee RL, Dowdy O, Miles L, Olabisi OA; CARE Community Partners. Hybrid Community-Electronic Health Record Approaches to Apolipoprotein L1 Kidney Disease Screening and Clinical Trials among Black Individuals. J Am Soc Nephrol. 2026 Mar 3. doi: 10.1681/ASN.0000001062. Online ahead of print.
• Shen CL, Richardson A, Martin-Fernandez M, Malle L, Buta S, Patel A, Rosberger H, Lim J, Horesh M, Saland J, Bogunovic D. Cytokine-Driven Janus Kinase Signal Transducer and Activator of Transcription Pathway Hyperactivity Predicts Disease Severity in Pediatric FSGS. Kidney360. 2026 Feb 1;7(2):260-268. doi: 10.34067/KID.0000001010. Epub 2025 Nov 14.

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2023
• Primary Completion (Actual): April 3, 2026
• Study Completion (Actual): April 3, 2026

Study Registration Dates

• First Submitted: January 31, 2022
• First Submitted That Met QC Criteria: January 31, 2022
• First Posted (Actual): February 14, 2022

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: APOL1; focal segmental glomerulosclerosis (FSGS)
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Glomerulonephritis; Nephritis; Pathological Conditions, Signs and Symptoms; Renal Insufficiency, Chronic; Glomerulosclerosis, Focal Segmental; baricitinib
• Other Study ID Numbers: Pro00108755; R01MD016401-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No