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

April 21, 2026 updated by: Duke University
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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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)
Time Frame: Baseline, monthly for 6 months
Baseline, monthly for 6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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