Janus Kinase-STAT Inhibition to Reduce APOL1 Associated Kidney Disease

Completed · Phase 2 · Has a placebo group

Conditions studied: Chronic Kidney Diseases

In brief

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).

Key facts

Study ID

NCT05237388

Run by

Duke University

People needed

8

Starts

2023-04-20

Expected to finish

2026-04-03

Last updated by the study team

2026-04-24

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Duke Research at Pickett Road — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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