75 Participants Needed

Baricitinib for Chronic Kidney Disease

(JUSTICE Trial)

JJ
OO
MS
Overseen ByMaurice Smith
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Duke University
Must be taking: Antihypertensives
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you have been on a stable antihypertensive medication regimen for at least 1 month before joining. You cannot participate if you are currently using certain potent immunosuppressants or high-dose corticosteroids. The protocol does not specify other medication restrictions, so it's best to discuss your current medications with the trial team.

What data supports the effectiveness of the drug Baricitinib for chronic kidney disease?

Baricitinib, a drug that blocks certain enzymes involved in inflammation, has shown promise in reducing kidney damage in people with diabetic kidney disease, which is a type of chronic kidney disease. This suggests it might help with other forms of chronic kidney disease as well.12345

How is the drug Baricitinib different from other treatments for chronic kidney disease?

Baricitinib is unique because it is primarily known as a treatment for rheumatoid arthritis and works by inhibiting Janus kinases (JAKs), which are enzymes involved in inflammation. This mechanism is different from other common treatments for chronic kidney disease, which often focus on controlling blood sugar or blood pressure.678910

What is the purpose of this trial?

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.

Research Team

OO

Opeyemi Olabisi, MD

Principal Investigator

Duke University

Eligibility Criteria

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.

Inclusion Criteria

My blood pressure medication has not changed in the last month.
I have been diagnosed with FSGS or have high blood pressure-related kidney disease.
Able to provide written informed consent
See 3 more

Exclusion Criteria

I am currently taking strong medications to suppress my immune system.
I have had a kidney transplant.
I have been treated with a JAK inhibitor before.
See 13 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Baricitinib or a placebo daily to assess the reduction of albuminuria

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Baricitinib
Trial Overview 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.
Participant Groups
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.

Baricitinib is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Olumiant for:
  • Rheumatoid arthritis
  • Severe alopecia areata
  • COVID-19
🇪🇺
Approved in European Union as Olumiant for:
  • Rheumatoid arthritis
  • Severe alopecia areata
  • COVID-19

Find a Clinic Near You

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials
2,495
Recruited
5,912,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials
473
Recruited
1,374,000+

Eli Lilly and Company

Industry Sponsor

Trials
2,708
Recruited
3,720,000+
Dr. Daniel Skovronsky profile image

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks profile image

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Findings from Research

Baricitinib, a selective JAK1 and JAK2 inhibitor, was found to be safe and well tolerated in healthy volunteers, with no serious treatment-related adverse events reported during the studies.
The drug demonstrated predictable pharmacokinetics, achieving peak plasma concentration within 1.5 hours and showing a dose-linear response, which suggests it could be effective for treating rheumatoid arthritis and other inflammatory disorders.
The pharmacokinetics, pharmacodynamics, and safety of baricitinib, an oral JAK 1/2 inhibitor, in healthy volunteers.Shi, JG., Chen, X., Lee, F., et al.[2021]
In a Phase 2 study involving 129 adults with Type 2 diabetes at high risk for diabetic kidney disease, baricitinib (4 mg daily) significantly reduced morning urine albumin-creatinine ratio (UACR) by 41% after 24 weeks compared to placebo, indicating its efficacy in lowering albuminuria.
Baricitinib also decreased several inflammatory biomarkers over the study period, although it was associated with a higher rate of anemia (32%) compared to placebo (3.7%), highlighting a potential safety concern that needs further investigation.
JAK1/JAK2 inhibition by baricitinib in diabetic kidney disease: results from a Phase 2 randomized controlled clinical trial.Tuttle, KR., Brosius, FC., Adler, SG., et al.[2021]
Baricitinib demonstrated a consistent safety profile over 128 weeks in patients with rheumatoid arthritis, with treatment-emergent adverse events occurring in 63% of patients on 4 mg and 67% on 8 mg, and no unexpected late safety signals identified.
Clinical improvements in disease symptoms were maintained beyond the initial 24-week blinded period, with similar or increased rates of disease improvement observed at weeks 76 and 128, indicating the long-term efficacy of baricitinib.
Safety and Efficacy of Baricitinib Through 128 Weeks in an Open-label, Longterm Extension Study in Patients with Rheumatoid Arthritis.Keystone, EC., Genovese, MC., Schlichting, DE., et al.[2021]

References

The pharmacokinetics, pharmacodynamics, and safety of baricitinib, an oral JAK 1/2 inhibitor, in healthy volunteers. [2021]
JAK1/JAK2 inhibition by baricitinib in diabetic kidney disease: results from a Phase 2 randomized controlled clinical trial. [2021]
Safety and Efficacy of Baricitinib Through 128 Weeks in an Open-label, Longterm Extension Study in Patients with Rheumatoid Arthritis. [2021]
Systematic Literature Review of Real-World Evidence on Baricitinib for the Treatment of Rheumatoid Arthritis. [2023]
Real-world Effectiveness and Safety of JAK Inhibitors in Rheumatoid Arthritis: A Single-centre Study. [2022]
Drug Testing for Residual Progression of Diabetic Kidney Disease in Mice Beyond Therapy with Metformin, Ramipril, and Empagliflozin. [2021]
SGLT2 inhibitors reduce adverse kidney and cardiovascular events in patients with advanced diabetic kidney disease: A population-based propensity score-matched cohort study. [2023]
Glucose-lowering treatment pathways of individuals with chronic kidney disease and type 2 diabetes according to the Kidney Disease: Improving Global Outcomes 2012 risk classification. [2023]
Efficacy and Safety of Dapagliflozin in Patients with Chronic Kidney Disease across the Spectrum of Frailty. [2023]
Impact of sodium-glucose cotransporter 2 inhibitors on renal function in participants with type 2 diabetes and chronic kidney disease with normoalbuminuria. [2022]
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