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Janus Kinase Inhibitor

Baricitinib for Chronic Kidney Disease (JUSTICE Trial)

Phase 2

Recruiting

Led By Opeyemi Olabisi, MD

Research Sponsored by Duke University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adults 18-70 years

FSGS diagnosed by kidney biopsy or clinically diagnosed HTN-CKD

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 months

Awards & highlights

JUSTICE Trial Summary

This trial will test if the drug baricitinib is safe and effective in reducing high levels of albumin in the urine for African Americans/Blacks with APOL1- associated FSGS and non-diabetic APOL1-associated CKD due to hypertension.

Who is the study for?

This trial is for African American/Black adults aged 18-70 with high-risk APOL1 genotype, diagnosed FSGS or HTN-CKD without diabetes, HIV, sickle cell disease, recent serious infections, previous kidney transplant, certain liver conditions or low blood counts. Participants must have stable blood pressure and not be on potent immunosuppressants.Check my eligibility

What is being tested?

The study tests if baricitinib can safely reduce albuminuria in patients with APOL1-associated kidney diseases compared to a placebo. It's focused on those who don't have diabetes but suffer from FSGS or chronic kidney disease due to hypertension.See study design

What are the potential side effects?

Baricitinib may cause side effects like infection risk increase due to immune system suppression, potential liver enzyme elevation which could indicate liver injury, and possibly changes in blood cell counts leading to anemia or increased bleeding/infection risk.

JUSTICE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 70 years old.

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I have been diagnosed with FSGS or have high blood pressure-related kidney disease.

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I have a high-risk APOL1 genotype.

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My kidney function test shows a rate of at least 26 ml/min.

JUSTICE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percent change in albuminuria (UACR)

Secondary outcome measures

Number of adverse events as measured by clinical lab value of hemoglobin less than 9.5g/dL

Number of adverse events as measured by patient report

Percent change in eGFR as measured by blood test

+1 more

JUSTICE Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: BaricitinibExperimental Treatment1 Intervention

Participants will take one pill of Baricitinib daily with their regular medications.

Group II: PlaceboPlacebo Group1 Intervention

Participants will take a Baricitinib placebo pill matching Baricitinib daily with their regular medications.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Baricitinib

2017

Completed Phase 3

~9510

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute on Minority Health and Health Disparities (NIMHD)NIH

383 Previous Clinical Trials

1,216,284 Total Patients Enrolled

Duke UniversityLead Sponsor

2,364 Previous Clinical Trials

3,420,567 Total Patients Enrolled

Eli Lilly and CompanyIndustry Sponsor

2,620 Previous Clinical Trials

3,216,524 Total Patients Enrolled

Media Library

Baricitinib (Janus Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05237388 — Phase 2

Chronic Kidney Disease Research Study Groups: Placebo, Baricitinib

Chronic Kidney Disease Clinical Trial 2023: Baricitinib Highlights & Side Effects. Trial Name: NCT05237388 — Phase 2

Baricitinib (Janus Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05237388 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are octogenarians being included in this study?

"The necessary qualifications for inclusion in this trial involve being between 18 and 70 years of age."

Answered by AI

Are there any adverse effects associated with the usage of Baricitinib?

"With a score of 2, Baricitinib is deemed to have some evidence for safety but no clinical data affirming its efficacy."

Answered by AI

Is this experimental therapy available to volunteers yet?

"As of this moment, the information found on clinicaltrials.gov indicates that patient recruitment for this trial is still in progress. It was first published on November 1st 2022 and has been amended as recently as September 26th 2022."

Answered by AI

How many individuals are participating in this research experiment?

"Affirmative. Records hosted on clinicaltrials.gov confirm that this medical investigation, which was first listed on November 1st 2022 is currently recruiting patients. Approximately 75 enrollees need to be acquired from one location."

Answered by AI

Am I eligible to join this research project?

"This trial seeks to enrol 75 members of the public that suffer from renal issues and are between 18-70 years old. To be eligible, applicants must have a High Risk APOL1 genotype (G1G1, G2G2 or G1G2), FSGS confirmed by biopsy or clinical diagnosis of HTN-CKD with UACR ≥300 mg/dL, eGFR at screening is required to exceed 30 ml/min/1.73 m2, a stable antihypertensive regimen for more than one month prior to signup and they need to provide written consent after being informed about"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Janus Kinase-STAT Inhibition to Reduce APOL1 Associated Kidney Disease

2023. "Janus Kinase-STAT Inhibition to Reduce APOL1 Associated Kidney Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05237388.

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