Janus Kinase-STAT Inhibition to Reduce APOL1 Associated Kidney Disease

• Status: Not yet recruiting
• Trial end date: 2026-03-31
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duke University
• Collaborators: Eli Lilly and Company; National Institute on Minority Health and Health Disparities (NIMHD)

Criteria

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) ≥30 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, cyclosporine, 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.