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

Duke University

Status and phase: Enrolling; Phase 2

Conditions: Chronic Kidney Diseases

Treatments: Drug: Placebo; Drug: Baricitinib

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT05237388

Pro00108755

R01MD016401-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Enrollment: 75 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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75 participants in 2 patient groups, including a placebo group

Baricitinib

Experimental group

Description:

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

Treatment:

Drug: Baricitinib

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo