What side effects are associated with this type of intervention?

Common treatments for Chronic Kidney Disease (CKD) include antihypertensive drugs, diuretics, and medications to control blood glucose and cholesterol levels. Side effects of these treatments can include electrolyte imbalances, increased urination, dizziness, and gastrointestinal issues. For treatments similar to Baricitinib, which is a Janus Kinase (JAK) inhibitor, side effects may include increased risk of infections, liver enzyme elevations, and blood abnormalities such as anemia and thrombocytopenia. It is important to monitor these side effects closely in patients undergoing treatment.

What prior FDA approvals exist?

The FDA has approved several treatments for Chronic Kidney Disease (CKD), primarily focusing on managing symptoms and slowing disease progression. These include angiotensin-converting enzyme (ACE) inhibitors and angiotensin II receptor blockers (ARBs) to control blood pressure and reduce proteinuria. Sodium-glucose co-transporter-2 (SGLT2) inhibitors, such as dapagliflozin, have also been approved for CKD treatment due to their renal protective effects. While Baricitinib, a Janus Kinase (JAK) inhibitor, is being studied for its potential in reducing albuminuria in CKD, there are currently no FDA-approved JAK inhibitors specifically for CKD treatment.

What other types of research exist?

Promising alternatives to Baricitinib for CKD patients include Everolimus and Sunitinib. These drugs have been studied in various trials for their efficacy in renal conditions and may offer novel treatment options for CKD patients in 2024.

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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

Must not have

Current use of potent immunosuppressants such as abatacept, adalimumab, anakinra, azathioprine, certolizumab, etanercept, golimumab, infliximab, probenecid, rituximab, ruxolitinib, sarilumab, tofacitinib, or tocilizumab

Previous kidney transplant

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Summary

This trial is testing if baricitinib can safely reduce high levels of albumin in the urine for African American/Blacks with certain kidney conditions. The drug works by reducing inflammation in the kidneys. Baricitinib has been previously tested for its effectiveness in reducing albumin in adults with Type 2 diabetes who are at high risk for worsening kidney disease.

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently taking strong medications to suppress my immune system.

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I have had a kidney transplant.

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I have been treated with a JAK inhibitor before.

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My liver tests are higher than normal due to chronic liver disease.

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I am HIV positive.

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I have sickle cell disease.

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I am currently fighting a serious infection.

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My kidney disease is identified as the tip variant of FSGS.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2015 Phase 3 trial • 1307 Patients • NCT01710358

Nasopharyngitis

Upper respiratory tract infection

Bronchitis

Influenza

Back pain

Urinary tract infection

Pharyngitis

100%

80%

60%

40%

20%

Study treatment Arm

BaricitinibTreatment B

Baricitinib Follow-up

Adalimumab Treatment B

Placebo Follow-up

Placebo Treatment B

Adalimumab Follow-up

Baricitinib Treatment A

Adalimumab Treatment A

Placebo Treatment A

Rescue

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 / 12Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Chronic Kidney Disease (CKD) include angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor blockers (ARBs), and Janus Kinase (JAK) inhibitors like Baricitinib. ACE inhibitors and ARBs work by reducing blood pressure and proteinuria, thereby slowing the progression of kidney damage. JAK inhibitors, such as Baricitinib, target the JAK-STAT signaling pathway, which is involved in inflammation and immune responses. By inhibiting this pathway, JAK inhibitors can reduce inflammation and potentially decrease the progression of kidney disease. These mechanisms are crucial for CKD patients as they help manage symptoms, reduce complications, and slow disease progression, improving overall quality of life.

Evidence-Based Medical Therapy in Patients With Heart Failure With Reduced Ejection Fraction and Chronic Kidney Disease.Effects of oral alkali drug therapy on clinical outcomes in pre-dialysis chronic kidney disease patients: a systematic review and meta-analysis.Socio-economic impact in CKD.