RecruitingPhase 2NCT05237388

Janus Kinase-STAT Inhibition to Reduce APOL1 Associated Kidney Disease

Sponsor

Duke University

Enrollment

75 participants

Start Date

Apr 20, 2023

Study Type

INTERVENTIONAL

Conditions

Chronic Kidney Diseases

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).

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria7

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 Criteria16

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.