Janus Kinase-STAT Inhibition to Reduce APOL1 Associated Kidney Disease

Chronic Kidney Diseases Clinical Trial

— JUSTICE  

Official title:

Janus Kinase-STAT Inhibition to Reduce APOL1 Associated Kidney Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05237388
• Other study ID #: Pro00108755
• Secondary ID: R01MD016401-01
• Status: Recruiting
• Phase: Phase 2
• Start date: April 20, 2023
• Est. completion date: March 31, 2026

Study information

• Verified date: March 2024
• Source: Duke University
• Contact: Maurice Smith
• Phone: 919 613 1386
• Email: maurice.w.smith[@]duke.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: March 31, 2026
• Est. primary completion date: March 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• Baricitinib
One pill daily
• Placebo
Baricitinib placebo pill

Locations

Country	Name	City	State
United States	Duke Research at Pickett Road	Durham	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Duke University	Eli Lilly and Company, National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent change in albuminuria (UACR)		Baseline, monthly for 6 months
Secondary	Percent change in eGFR as measured by blood test		Baseline, monthly for 6 months
Secondary	Percent change in urine CXCL 9-11 as measured by urine test		Baseline, monthly for 6 months
Secondary	Number of adverse events as measured by patient report		Up to 6 months
Secondary	Number of adverse events as measured by clinical lab value of hemoglobin less than 9.5g/dL		Up to 6 months